Clinical trial • Phase III • Immunology|Gastroenterology|Rare Disease
seladelpar for Primary biliary cholangitis
Phase III trial of seladelpar for Primary biliary cholangitis. open-label, none/not specified-controlled. 272 participants.
Overview
- Trial Therapeutic Area
- Immunology|Gastroenterology|Rare Disease
- Trial Disease
- Primary biliary cholangitis
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 29-05-2024
- First CTIS Authorization Date
- 11-07-2024
Trial design
open-label, none/not specified-controlled Phase III trial in Netherlands, Hungary, Austria and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 272
Eligibility
Recruits 272 The trial record indicates vulnerable population selection (isVulnerablePopulationSelected = true). Subjects must provide written informed consent: "Must have given informed consent (signed and dated)". Multiple informed consent forms are provided (main ICF, pregnant-partner/newborn ICFs, genomic ICF, optional research ICFs) in country-specific languages. No explicit mention of assent procedures for minors is provided in the available documents..
- Pregnancy Exclusion
- For females, pregnancy or breast-feeding
- Vulnerable Population
- The trial record indicates vulnerable population selection (isVulnerablePopulationSelected = true). Subjects must provide written informed consent: "Must have given informed consent (signed and dated)". Multiple informed consent forms are provided (main ICF, pregnant-partner/newborn ICFs, genomic ICF, optional research ICFs) in country-specific languages. No explicit mention of assent procedures for minors is provided in the available documents.
Inclusion criteria
- {"criterion_text":"-Must have given informed consent (signed and dated)"}
- {"criterion_text":"-Participated in a prior PBC study with seladelpar (e.g., including CB8025-21629, CB8025-31735, or CB8025-31731), current PBC studies (CB8025-32048 or CB8025-21838), or completed a future PBC study with seladelpar that allows rollover into CB8025-31731-RE, and meet eligibility criteria for the current study."}
- {"criterion_text":"-Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose"}
Exclusion criteria
- {"criterion_text":"-Exclusion criteria are only applicable for subjects with a study drug interruption greater than 4 weeks prior to Day 1 of this study and for subjects who participated in CB8025-21838 irrespective of seladelpar interruption 1. Treatment-related AE leading to study drug discontinuation in a previous PBC study with seladelpar"}
- {"criterion_text":"-Known history of alpha-1-antitrypsin deficiency"}
- {"criterion_text":"-Known history of chronic viral hepatitis"}
- {"criterion_text":"-For females, pregnancy or breast-feeding"}
- {"criterion_text":"-Use of colchicine, methotrexate, azathioprine or long-term use of systemic steroids (e.g. prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to Screening. See the concomitant medication section for additional medications that may be excluded."}
- {"criterion_text":"-Current use of fibrates or use of fibrates within 3 months prior to Screening"}
- {"criterion_text":"-Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening"}
- {"criterion_text":"-Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening"}
- {"criterion_text":"-History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening"}
- {"criterion_text":"-Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening"}
- {"criterion_text":"-Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study as judged by the Investigator"}
- {"criterion_text":"-A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer, any active infection)"}
- {"criterion_text":"-Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, antiTNF or other immunosuppressive biologics)"}
- {"criterion_text":"-Other medications that effect liver or GI functions such as absorption of medications may be prohibited and should be discussed with the medical monitor on a case-by-case basis"}
- {"criterion_text":"-Positive for: a. Hepatitis B, defined as the presence of hepatitis B surface antigen b. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid c. Human immunodeficiency virus (HIV) antibody"}
- {"criterion_text":"-Active COVID-19 infection during Screening."}
- {"criterion_text":"-AST or ALT above 3 × the upper limit of normal (ULN)"}
- {"criterion_text":"-Total bilirubin above 2 × ULN"}
- {"criterion_text":"-MELD score ≥ 12. For subjects on anticoagulation medication, evaluation of the baseline INR, in concert with any current dose adjustments in anti-coagulant medications, will be taken into account when calculating this score. This will be done in consultation with the medical monitor."}
- {"criterion_text":"-Evidence of advanced PBC as defined by the Rotterdam criteria (albumin below 1 × lower limit of normal AND total bilirubin above 1 × ULN)"}
- {"criterion_text":"-Estimated glomerular filtration rate ≤ 45 mL/min/1.73 m2 (calculated by Modification of Diet in Renal Disease formula)"}
- {"criterion_text":"-Auto-immune hepatitis"}
- {"criterion_text":"-Primary sclerosing cholangitis"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Treatment-emergent AEs (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0), biochemistry and hematology results are collected","definition_or_measurement_approach":"Treatment-emergent adverse events collected and graded using NCI CTCAE Version 5.0; collection of biochemistry and hematology laboratory results."}
Secondary endpoints
- {"endpoint_text":"-Occurrence of the following adjudicated PBC clinical outcomes: -Overall death -Liver transplantation -MELD score ≥ 15 for at least 2 consecutive visits -Ascites requiring treatment -Hospitalization for new onset or recurrence, of any: -Variceal bleeding, Hepatic encephalopathy, Spontaneous bacterial peritonitis","definition_or_measurement_approach":"Adjudicated clinical PBC outcomes tracked including all-cause mortality, liver transplantation, MELD ≥15 on ≥2 consecutive visits, clinically significant ascites, and hospitalizations for variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis (definitions and adjudication described in protocol)."}
- {"endpoint_text":"-Biochemical markers: -Response on composite of ALP and total bilirubin -Proportion of subjects with normalization of ALP -Relative and absolute changes of the following: -Alkaline phosphatase (ALP) -Aspartate aminotransferase (AST) -Alanine aminotransferase (ALT) -Gamma-glutamyl transferase (GGT) -Bilirubin (total, direct, indirect)","definition_or_measurement_approach":"Biochemical response assessed by composite ALP and total bilirubin criteria; proportion with ALP normalization; relative and absolute changes in listed liver enzymes and bilirubin measured by standard laboratory assays."}
- {"endpoint_text":"-Change from Baseline in pruritus NRS","definition_or_measurement_approach":"Pruritus measured using the Numerical Rating Scale (NRS); change from baseline score calculated."}
Recruitment
- Registry Or Advocacy Recruitment
- True — Site-and-Patient-advocacy contact lists are provided (document: 'Site-and-Patient-advocacy_Contact-List-for-ICF_AT_clean_Public').
- Digital Remote Recruitment
- True — digital/remote methods documented include email communication (Scout Email Communication), eCOA/ePRO handheld and electronic patient-reported outcome tools (multiple 'ePRO'/'eCOA' documents), and Direct-to-Patient logistics.
- Planned Sample Size
- 272
- Recruitment Window Months
- 59
- Consent Approach
- Informed consent is required from each subject ("Must have given informed consent (signed and dated)"). Subjects sign the main ICF prior to any study procedures; additional specific consent forms are provided for pregnant participants, pregnant partners/newborn follow-up, genomic research, optional sub-studies and optional procedures. Country-specific ICFs are provided in multiple languages (examples in the record include: English, Dutch, Hungarian, Greek, French, Polish, Spanish, German, Italian, Czech, Romanian). There is no explicit mention of assent procedures for minors in the available documents.
Methods
- Direct to Patient (DTP) distribution and home delivery (documented via third party MARKEN Germany GmbH with duty 'Direct to Patient (DTP)')
- Email outreach via Scout Clinical (documents: 'Scout Email Communication'; third party 'Scout Clinical' involved) for patient communication and recruitment support
- Primary care / PCP patient-enrolment letters (document: 'ASSURE_PCP-Patient-Enrollment-Letter') and patient welcome/visit reminder cards (documents: 'Patient Welcome Letter', 'Patient-Visit-Reminder-Card')
- On-site/site-based recruitment through participating hospitals and hepatology/gastroenterology clinics (multiple site documents and ICFs per country)
Geography
- Total Number Of Sites
- 29
- Total Number Of Participants
- 272
Netherlands
- Earliest CTIS Part Ii Submission Date
- 21-06-2024
- Latest Decision Or Authorization Date
- 11-07-2024
- Processing Time Days
- 20
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Stichting Radboud universitair medisch centrum
- Department Name
- MDL
- Principal Investigator Name
- Eric Tjwa
- Principal Investigator Email
- Eric.Tjwa@radboudumc.nl
- Contact Person Name
- Eric Tjwa
- Contact Person Email
- Eric.Tjwa@radboudumc.nl
Hungary
- Earliest CTIS Part Ii Submission Date
- 22-05-2024
- Latest Decision Or Authorization Date
- 15-07-2024
- Processing Time Days
- 54
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
- Principal Investigator Name
- Attila Haragh
- Principal Investigator Email
- haragatt@pazmanykabel.hu
- Contact Person Name
- Attila Haragh
- Contact Person Email
- haragatt@pazmanykabel.hu
- Site Name
- Semmelweis University
- Department Name
- I. sz. Sebeszeti es Intervencios Gasztroenterologiai Klinika
- Principal Investigator Name
- Krisztina Hagymasi
- Principal Investigator Email
- hagymasi.krisztina@med.semmelweis-univ.hu
- Contact Person Name
- Krisztina Hagymasi
- Contact Person Email
- hagymasi.krisztina@med.semmelweis-univ.hu
Austria
- Earliest CTIS Part Ii Submission Date
- 01-07-2024
- Latest Decision Or Authorization Date
- 16-07-2024
- Processing Time Days
- 15
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Klinikum Wels-Grieskirchen GmbH
- Department Name
- Department of Internal Medicine I, Klinikum Wels-Grieskirchen
- Principal Investigator Name
- Harald Hofer
- Principal Investigator Email
- harald.hofer@klinikum-wegr.at
- Contact Person Name
- Harald Hofer
- Contact Person Email
- harald.hofer@klinikum-wegr.at
Poland
- Earliest CTIS Part Ii Submission Date
- 22-05-2024
- Latest Decision Or Authorization Date
- 15-07-2024
- Processing Time Days
- 54
- Number Of Sites
- 2
- Number Of Participants
- 11
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
- Department Name
- Oddział Gastroenterologii i Hepatologii
- Principal Investigator Name
- Agata Bacik
- Principal Investigator Email
- agatapl@poczta.fm
- Contact Person Name
- Agata Bacik
- Contact Person Email
- agatapl@poczta.fm
- Site Name
- ID Clinic Arkadiusz Pisula
- Department Name
- Investigator
- Principal Investigator Name
- Ewa Janczewska
- Principal Investigator Email
- e.janczewska@poczta.fm
- Contact Person Name
- Ewa Janczewska
- Contact Person Email
- e.janczewska@poczta.fm
Spain
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 15-07-2024
- Processing Time Days
- 53
- Number Of Sites
- 7
- Number Of Participants
- 13
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hepatology Department
- Principal Investigator Name
- Elena Gomez Dominguez
- Principal Investigator Email
- elenagodo@hotmail.com
- Contact Person Name
- Elena Gomez Dominguez
- Contact Person Email
- elenagodo@hotmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Liver Unit-Internla Medicine department
- Principal Investigator Name
- Ares Villagrasa Vilella
- Principal Investigator Email
- aresaurora.villagrasa@vallhebron.cat
- Contact Person Name
- Ares Villagrasa Vilella
- Contact Person Email
- aresaurora.villagrasa@vallhebron.cat
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Servicio de Gastroenterología.
- Principal Investigator Name
- Rosa Maria Morillas
- Principal Investigator Email
- rmorillas.germanstrias@gencat.cat
- Contact Person Name
- Rosa Maria Morillas
- Contact Person Email
- rmorillas.germanstrias@gencat.cat
- Site Name
- Hospital Universitario La Paz
- Department Name
- Servicio de Digestivo
- Principal Investigator Name
- Pilar Castillo Grau
- Principal Investigator Email
- pcastillograu@gmail.com
- Contact Person Name
- Pilar Castillo Grau
- Contact Person Email
- pcastillograu@gmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Gastroenteroloy and Hepatology department
- Principal Investigator Name
- Alvaro Diaz Gonzalez
- Principal Investigator Email
- alvaro.diaz@scsalud.es
- Contact Person Name
- Alvaro Diaz Gonzalez
- Contact Person Email
- alvaro.diaz@scsalud.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Gastroenterology and Hepatology Department
- Principal Investigator Name
- Raul Jesus Andrade Bellido
- Principal Investigator Email
- andrade@uma.es
- Contact Person Name
- Raul Jesus Andrade Bellido
- Contact Person Email
- andrade@uma.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Liver Unit
- Principal Investigator Name
- Maria Carlota Londoño Hurtado
- Principal Investigator Email
- mlondono@clinic.cat
- Contact Person Name
- Maria Carlota Londoño Hurtado
- Contact Person Email
- mlondono@clinic.cat
Belgium
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 11-07-2024
- Processing Time Days
- 49
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- UZ Leuven
- Department Name
- Gastroenterology & Hepatology
- Principal Investigator Name
- Jef Verbeek
- Principal Investigator Email
- jef.verbeek@uzleuven.be
- Contact Person Name
- Jef Verbeek
- Contact Person Email
- jef.verbeek@uzleuven.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Hepatology & Gastroenterology
- Principal Investigator Name
- Xavier Verhelst
- Principal Investigator Email
- xavier.verhelst@uzgent.be
- Contact Person Name
- Xavier Verhelst
- Contact Person Email
- xavier.verhelst@uzgent.be
France
- Earliest CTIS Part Ii Submission Date
- 22-05-2024
- Latest Decision Or Authorization Date
- 16-07-2024
- Processing Time Days
- 55
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- HepatoGastroenterology Department
- Principal Investigator Name
- Christophe CORPECHOT
- Principal Investigator Email
- christophe.corpechot@aphp.fr
- Contact Person Name
- Christophe CORPECHOT
- Contact Person Email
- christophe.corpechot@aphp.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- HepatoGastroenterology Department
- Principal Investigator Name
- Domitille Erard
- Principal Investigator Email
- domitille.erard@chu-lyon.fr
- Contact Person Name
- Domitille Erard
- Contact Person Email
- domitille.erard@chu-lyon.fr
Greece
- Earliest CTIS Part Ii Submission Date
- 23-05-2024
- Latest Decision Or Authorization Date
- 29-07-2024
- Processing Time Days
- 67
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- General University Hospital Of Larissa
- Department Name
- Department of Medicine and Reasearch Laboratory of Internal Medicine
- Principal Investigator Name
- George Dalekos
- Principal Investigator Email
- georgedalekos@gmail.com
- Contact Person Name
- George Dalekos
- Contact Person Email
- georgedalekos@gmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 15-07-2024
- Processing Time Days
- 52
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Interní a kardiologická klinika - Oddělení gastroenterologie, hepatologie a pankreatologie
- Principal Investigator Name
- Adam Vašura
- Principal Investigator Email
- adam.vasura@fno.cz
- Contact Person Name
- Adam Vašura
- Contact Person Email
- adam.vasura@fno.cz
Italy
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 16-07-2024
- Processing Time Days
- 53
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Department Name
- Sezione Di Endocrinologia - Dipartimento Di Oncologia Sperimentale Ed Applicazioni Cliniche (dosac)
- Principal Investigator Name
- Vincenza Calvaruso
- Principal Investigator Email
- vincenza.calvaruso@unipa.it
- Contact Person Name
- Vincenza Calvaruso
- Contact Person Email
- vincenza.calvaruso@unipa.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- Medicina Interna metabolica
- Principal Investigator Name
- Alessia Cavicchioli
- Principal Investigator Email
- alessia.cavicchioli.1990@gmail.com
- Contact Person Name
- Alessia Cavicchioli
- Contact Person Email
- alessia.cavicchioli.1990@gmail.com
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- Gastroenterologia
- Principal Investigator Name
- Pietro Invernizzi
- Principal Investigator Email
- pietro.invernizzi@unimib.it
- Contact Person Name
- Pietro Invernizzi
- Contact Person Email
- pietro.invernizzi@unimib.it
Romania
- Earliest CTIS Part Ii Submission Date
- 22-05-2024
- Latest Decision Or Authorization Date
- 16-07-2024
- Processing Time Days
- 55
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Institutul Clinic Fundeni
- Department Name
- Gastroenterology III
- Principal Investigator Name
- Liliana-Simona Gheorghe
- Principal Investigator Email
- drlgheorghe@gmail.com
- Contact Person Name
- Liliana-Simona Gheorghe
- Contact Person Email
- drlgheorghe@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 01-07-2024
- Latest Decision Or Authorization Date
- 15-07-2024
- Processing Time Days
- 14
- Number Of Sites
- 6
- Number Of Participants
- 12
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medical Polyclinic
- Principal Investigator Name
- Ulrike Morgera
- Principal Investigator Email
- ulrike.morgera@charite.de
- Contact Person Name
- Ulrike Morgera
- Contact Person Email
- ulrike.morgera@charite.de
- Site Name
- ifi-Medizin GmbH
- Department Name
- Haus L
- Principal Investigator Name
- Peter Buggisch
- Principal Investigator Email
- Peter.Buggisch@amedes-group.com
- Contact Person Name
- Peter Buggisch
- Contact Person Email
- Peter.Buggisch@amedes-group.com
- Site Name
- Gastroenterologische Gemeinschaftspraxis Herne
- Principal Investigator Name
- Matthias Hinz
- Principal Investigator Email
- hinz@gastro-praxis-herne.de
- Contact Person Name
- Matthias Hinz
- Contact Person Email
- hinz@gastro-praxis-herne.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Medizinische Klinik, Innere Medizin 1
- Principal Investigator Name
- Christoph Berg
- Principal Investigator Email
- christoph.berg@med.uni-tuebingen.de
- Contact Person Name
- Christoph Berg
- Contact Person Email
- christoph.berg@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Gastroenterology, Pneumology and Endocrinology
- Principal Investigator Name
- Peter Dietrich
- Principal Investigator Email
- peter.dietrich@uk-erlangen.de
- Contact Person Name
- Peter Dietrich
- Contact Person Email
- peter.dietrich@uk-erlangen.de
- Site Name
- Gastroenterologic Hepatologic Center Kiel (Gastroenterologisch-Hepatologisches MVZ Kiel GmbH)
- Department Name
- Gastroenterologic Hepatologic Center Kiel
- Principal Investigator Name
- Holger Hinrichsen
- Principal Investigator Email
- holger.hinrichsen@gastroenterologie-kiel.de
- Contact Person Name
- Holger Hinrichsen
- Contact Person Email
- holger.hinrichsen@gastroenterologie-kiel.de
Sponsor
Primary sponsor
- Full Name
- Gilead Sciences Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Global Ltd.
- Responsibilities
- codes: 1,5
- Name
- PPD Development LP
- Responsibilities
- codes: 1,10,11,12,14,2,5,8,9
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"EDC/RAVE and Patient Profiles/CSA","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Metabolon Inc.","duties_or_roles":"Biomarkers, exploratory measures, Sample receiving","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"codes: 1,5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"Exploratory measures","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"FMD K And L Inc.","duties_or_roles":"Biostatistics","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Analytical chemistry, Sample receiving","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Certara USA Inc.","duties_or_roles":"Pharmacology Analysis","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"United BioSource (Suisse) S.A.","duties_or_roles":"Safety Database","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharma Start LLC","duties_or_roles":"Home Health Care","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"Direct to Patient (DTP)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes: 1,10,11,12,14,2,5,8,9","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePatient Reported Outcomes (ePRO)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Quest Diagnostics Nichols Institute Inc.","duties_or_roles":"Serology/Endocrinology","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"Clinical chemistry, Clinical haematology, Serology/Endocrinology, Immunology","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Travel and Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Medpace Reference Laboratories LLC","duties_or_roles":"Clinical chemistry, Clinical haematology, Analytical chemistry","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"Biopsy slide preparation and staining","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- MBX-8025 10 mg capsule
- Active Substance
- seladelpar
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Frequency
- once daily
- Maximum Dose
- 10 mg
- Investigational Product Name
- MBX-8025 5 mg capsule
- Active Substance
- seladelpar
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Frequency
- once daily
- Maximum Dose
- 10 mg
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