Clinical trial • Phase II • Cardiology
NINERAFAXSTAT TRIHYDROCHLORIDE MONOHYDRATE for Non-obstructive hypertrophic cardiomyopathy
Phase II trial of NINERAFAXSTAT TRIHYDROCHLORIDE MONOHYDRATE for Non-obstructive hypertrophic cardiomyopathy.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Non-obstructive hypertrophic cardiomyopathy
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 06-08-2025
- First CTIS Authorization Date
- 20-11-2025
Trial design
Randomised, placebo: 'tablet, identical in appearance to ninerafaxstat tablets' (matching placebo). active comparator: ninerafaxstat 200 mg mr bid (modified-release tablet, oral).-controlled Phase II trial in Austria, France, Poland and others.
- Randomised
- Yes
- Comparator
- Placebo: 'Tablet, identical in appearance to ninerafaxstat tablets' (matching placebo). Active comparator: Ninerafaxstat 200 mg MR BID (modified-release tablet, oral).
- Target Sample Size
- 80
- Trial Duration For Participant
- 365
Stratification factors
- CPET exercise modality
- KCCQ-CSS score
- BMI
Eligibility
Recruits 80 isVulnerablePopulationSelected is true. Participants must be able to comprehend and sign an informed consent form: "Able to comprehend and willing to sign an informed consent form (ICF), and willing to comply with all trial procedures and restrictions for the duration specified in the Schedule of Events. Understands the risks involved." Pregnant or breastfeeding women are excluded and specific pregnancy-related ICFs/documents are provided..
- Pregnancy Exclusion
- 6. Pregnancy and Lactation: • Pregnant or breastfeeding women. • Women of childbearing potential not willing to use effective contraception during the study and for a specified period after the last dose.
- Vulnerable Population
- isVulnerablePopulationSelected is true. Participants must be able to comprehend and sign an informed consent form: "Able to comprehend and willing to sign an informed consent form (ICF), and willing to comply with all trial procedures and restrictions for the duration specified in the Schedule of Events. Understands the risks involved." Pregnant or breastfeeding women are excluded and specific pregnancy-related ICFs/documents are provided.
Inclusion criteria
- {"criterion_text":"- All inclusion criteria can be found in the protocol (Section 5.1). 1. Informed Consent: Able to comprehend and willing to sign an informed consent form (ICF), and willing to comply with all trial procedures and restrictions for the duration specified in the Schedule of Events. Understands the risks involved.\n- 2. Age: Individual ≥18 years of age at the time of signing informed consent.\n- 3. Echocardiography: Has adequate acoustic windows for echocardiography.\n- 4. Clinical Diagnosis: Has a clinical diagnosis of hypertrophic cardiomyopathy (HCM) consistent with current American College of Cardiology/American Heart Association and European Society of Cardiology Guideline definition, with unexplained left ventricular hypertrophy (LVH) in the absence of other cardiac or systemic diseases that can produce the magnitude of hypertrophy observed."}
Exclusion criteria
- {"criterion_text":"- All exclusion criteria can be found in the protocol (Section 5.2). 1. Informed Consent: Inability or unwillingness to provide informed consent or comply with trial procedures.\n- 2. Cardiovascular Conditions: •\tHistory of obstructive hypertrophic cardiomyopathy (HCM) with left ventricular outflow tract (LVOT) gradient ≥30 mmHg at rest or with provocation. •\tHistory of major adverse cardiovascular events (MACE) within 6 months prior to screening, including myocardial infarction, stroke, or cardiac surgery.\n- 3. Medical Conditions: •\tSignificant comorbidities that may impact the ability to complete the trial or the interpretation of results, such as uncontrolled diabetes, severe renal impairment, or active infection. •\tKnown history of hepatitis B or C infection, or HIV infection.\n- 4. Medications: •\tUse of disallowed medications that may interfere with the trial, such as other investigational drugs within 30 days prior to screening. •\tRequirement for treatment with drugs that may affect the study outcomes, such as certain antiarrhythmic or antihypertensive medications.\n- 5. Substance Abuse: History of alcohol or substance abuse within the past year.\n- 6. Pregnancy and Lactation: •\tPregnant or breastfeeding women. •\tWomen of childbearing potential not willing to use effective contraception during the study and for a specified period after the last dose.\n- 7. Other Exclusions: •\tParticipation in another clinical trial within 30 days prior to screening. •\tAny condition that, in the opinion of the investigator, would make participation in the trial unsafe or otherwise not in the best interest of the participant."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline to Week 12 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS).","definition_or_measurement_approach":"Change from baseline to Week 12 in the KCCQ Clinical Summary Score (KCCQ-CSS); measured by KCCQ score at baseline and at Week 12."}
Secondary endpoints
- {"endpoint_text":"- 1. Change in ventilatory efficiency (VE/VCO2 slope) during CPET from baseline to Week 12","definition_or_measurement_approach":"Change from baseline to Week 12 in VE/VCO2 slope measured during cardiopulmonary exercise testing (CPET)."}
- {"endpoint_text":"- 2. Change from baseline to Week 12 in the KCCQ-TSS","definition_or_measurement_approach":"Change from baseline to Week 12 in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS)."}
- {"endpoint_text":"- 3. Change from baseline to Week 12 in the KCCQ-PLS","definition_or_measurement_approach":"Change from baseline to Week 12 in the KCCQ Physical Limitation Score (KCCQ-PLS)."}
- {"endpoint_text":"- 4. Change from baseline to Week 12 in the KCCQ-OSS","definition_or_measurement_approach":"Change from baseline to Week 12 in the KCCQ Overall Summary Score (KCCQ-OSS)."}
- {"endpoint_text":"- 5. Change in exercise duration during CPET from baseline to Week 12","definition_or_measurement_approach":"Change from baseline to Week 12 in exercise duration during CPET (timed CPET performance)."}
Recruitment
- Registry Or Advocacy Recruitment
- True, Fondazione Toscana Gabriele Monasterio (listed as a patient organisation/association involved as third party) and a 'Site-Patient-advocacy-Contact-List' document are present.
- Planned Sample Size
- 80
- Recruitment Window Months
- 10
- Consent Approach
- Participants must provide written informed consent themselves (inclusion criterion: 'Able to comprehend and willing to sign an informed consent form (ICF)...'). Only adults ≥18 years may enroll (no assent). Multiple language ICFs and related documents are provided (examples include English, German, French, Spanish, Portuguese, Polish, Italian, Dutch). Pregnancy-related ICFs are available where applicable; pregnancy and lactation are exclusion criteria.
Methods
- Country-specific recruitment arrangements packages (documents titled 'Recruitment arrangements' for multiple countries) - materials include fact sheets, recruitment brochures, flipcharts, appointment cards, patient letters and GP/doctor letters.
- Direct site-based recruitment using patient letters and doctor-to-doctor/GP letters (country-specific documents present for DE, FR, PL, IT, ES, PT, NL, BE, AT).
- Printed materials and appointment cards (country-specific) to schedule screening/visits.
- Core laboratory outreach (e.g. cardiopulmonary exercise testing and echocardiography core labs named in third-party roles) supporting site activities.
Geography
- Total Number Of Sites
- 40
- Total Number Of Participants
- 130
Austria
- Earliest CTIS Part Ii Submission Date
- 02-10-2025
- Latest Decision Or Authorization Date
- 23-11-2025
- Processing Time Days
- 52
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Medical University Of Graz
- Department Name
- Klinische Abteilung für Kardiologie
- Principal Investigator Name
- Nicolas Dominik Verheyen
- Principal Investigator Email
- nicolas.verheyen@medunigraz.at
- Contact Person Name
- Nicolas Dominik Verheyen
- Contact Person Email
- nicolas.verheyen@medunigraz.at
France
- Earliest CTIS Part Ii Submission Date
- 03-11-2025
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 18
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Cardiology
- Principal Investigator Name
- Nicolas PIRIOU
- Principal Investigator Email
- nicolas.piriou@chu-nantes.fr
- Contact Person Name
- Nicolas PIRIOU
- Contact Person Email
- nicolas.piriou@chu-nantes.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Principal Investigator Name
- Albert HAGEGE
- Principal Investigator Email
- albert.hagege@aphp.fr
- Contact Person Name
- Albert HAGEGE
- Contact Person Email
- albert.hagege@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Cardiology
- Principal Investigator Name
- François ROUBILLE
- Principal Investigator Email
- f-roubille@chu-montpellier.fr
- Contact Person Name
- François ROUBILLE
- Contact Person Email
- f-roubille@chu-montpellier.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 18-11-2025
- Latest Decision Or Authorization Date
- 30-11-2025
- Processing Time Days
- 12
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclaw
- Department Name
- Ośrodek Chorób Serca, Klinika Kardiologii, Oddział Niewydolności Serca
- Principal Investigator Name
- Bartosz Krakowiak
- Principal Investigator Email
- bartek.krakowiak@gmail.com
- Contact Person Name
- Bartosz Krakowiak
- Contact Person Email
- bartek.krakowiak@gmail.com
- Site Name
- Kardio Brynow Sp. z o.o.
- Principal Investigator Name
- Wojciech Wojakowski
- Principal Investigator Email
- wojtek.wojakowski@gmail.com
- Contact Person Name
- Wojciech Wojakowski
- Contact Person Email
- wojtek.wojakowski@gmail.com
- Site Name
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Department Name
- Klinika Kardiologii
- Principal Investigator Name
- Agnieszka Pawlak
- Principal Investigator Email
- agnieszka.pawlak@pimmswia.gov.pl
- Contact Person Name
- Agnieszka Pawlak
- Contact Person Email
- agnieszka.pawlak@pimmswia.gov.pl
Netherlands
- Earliest CTIS Part Ii Submission Date
- 18-11-2025
- Latest Decision Or Authorization Date
- 20-11-2025
- Processing Time Days
- 2
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Amsterdam UMC Research B.V.
- Department Name
- Cardiology
- Principal Investigator Name
- Ahmad Amin
- Principal Investigator Email
- a.s.amin@amsterdamumc.nl
- Contact Person Name
- Ahmad Amin
- Contact Person Email
- a.s.amin@amsterdamumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Cardiology
- Principal Investigator Name
- Michelle Michels
- Principal Investigator Email
- m.michels@erasmusmc.nl
- Contact Person Name
- Michelle Michels
- Contact Person Email
- m.michels@erasmusmc.nl
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Cardiology
- Principal Investigator Name
- Robin Nijveldt
- Principal Investigator Email
- onderzoek.cardio@radboudumc.nl
- Contact Person Name
- Robin Nijveldt
- Contact Person Email
- onderzoek.cardio@radboudumc.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Cardiology
- Principal Investigator Name
- Nina Ajmone Marsan
- Principal Investigator Email
- N.Ajmone@lumc.nl
- Contact Person Name
- Nina Ajmone Marsan
- Contact Person Email
- N.Ajmone@lumc.nl
Belgium
- Earliest CTIS Part Ii Submission Date
- 27-08-2025
- Latest Decision Or Authorization Date
- 20-11-2025
- Processing Time Days
- 85
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Cardiology
- Principal Investigator Name
- Emeline Van Craenenbroeck
- Principal Investigator Email
- emeline.vancraenenbroeck@uantwerpen.be
- Contact Person Name
- Emeline Van Craenenbroeck
- Contact Person Email
- emeline.vancraenenbroeck@uantwerpen.be
Germany
- Earliest CTIS Part Ii Submission Date
- 03-11-2025
- Latest Decision Or Authorization Date
- 20-11-2025
- Processing Time Days
- 17
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Klinik für Kardiologie, Angiologie und Pneumologie
- Principal Investigator Name
- Benjamin Meder
- Principal Investigator Email
- Benjamin.Meder@med.uni-heidelberg.de
- Contact Person Name
- Benjamin Meder
- Contact Person Email
- Benjamin.Meder@med.uni-heidelberg.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik für Kardiologie und Pneumologie
- Principal Investigator Name
- Soeren Brandenburg
- Principal Investigator Email
- soeren.brandenburg@med.uni-goettingen.de
- Contact Person Name
- Soeren Brandenburg
- Contact Person Email
- soeren.brandenburg@med.uni-goettingen.de
- Site Name
- Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
- Department Name
- Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie
- Principal Investigator Name
- Smita Scholtz
- Principal Investigator Email
- sscholtz@hdz-nrw.de
- Contact Person Name
- Smita Scholtz
- Contact Person Email
- sscholtz@hdz-nrw.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Klinik für Innere Medizin I
- Principal Investigator Name
- Julian Westphal
- Principal Investigator Email
- Julian.Westphal@med.uni-jena.de
- Contact Person Name
- Julian Westphal
- Contact Person Email
- Julian.Westphal@med.uni-jena.de
Portugal
- Earliest CTIS Part Ii Submission Date
- 08-10-2025
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 44
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Unidade Local De Saude Do Alto Ave E.P.E.
- Department Name
- Cardiology Department
- Principal Investigator Name
- Olga Azevedo
- Principal Investigator Email
- olgazevedo@yahoo.com.br
- Contact Person Name
- Olga Azevedo
- Contact Person Email
- olgazevedo@yahoo.com.br
- Site Name
- Hospital Da Luz S.A.
- Department Name
- Cardiology Department
- Principal Investigator Name
- Alexandra Toste
- Principal Investigator Email
- atoste@hospitaldaluz.pt
- Contact Person Name
- Alexandra Toste
- Contact Person Email
- atoste@hospitaldaluz.pt
- Site Name
- Unidade Local De Saude De Sao Jose E.P.E.
- Department Name
- Cardiology Department
- Principal Investigator Name
- Sílvia Aguiar Rosa
- Principal Investigator Email
- silvia.rosa@ulssjose.min-saude.pt
- Contact Person Name
- Sílvia Aguiar Rosa
- Contact Person Email
- silvia.rosa@ulssjose.min-saude.pt
Spain
- Earliest CTIS Part Ii Submission Date
- 23-10-2025
- Latest Decision Or Authorization Date
- 05-12-2025
- Processing Time Days
- 43
- Number Of Sites
- 15
- Number Of Participants
- 45
Sites
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Cardiology
- Principal Investigator Name
- Roberto Barriales Villa
- Principal Investigator Email
- Roberto.barriales.villa@sergas.es
- Contact Person Name
- Roberto Barriales Villa
- Contact Person Email
- Roberto.barriales.villa@sergas.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Cardiology
- Principal Investigator Name
- Marta De Antonio Ferrer
- Principal Investigator Email
- mantoniof@santpau.cat
- Contact Person Name
- Marta De Antonio Ferrer
- Contact Person Email
- mantoniof@santpau.cat
- Site Name
- Bellvitge University Hospital
- Department Name
- Cardiology
- Principal Investigator Name
- Carles Diez Lopez
- Principal Investigator Email
- soceldiez@gmail.com
- Contact Person Name
- Carles Diez Lopez
- Contact Person Email
- soceldiez@gmail.com
- Site Name
- Hospital Alvaro Cunqueiro
- Department Name
- Cardiology
- Principal Investigator Name
- Rafael Jose Cobas Paz
- Principal Investigator Email
- rafael.jose.cobas.paz@sergas.es
- Contact Person Name
- Rafael Jose Cobas Paz
- Contact Person Email
- rafael.jose.cobas.paz@sergas.es
- Site Name
- Hospital Son Llatzer
- Department Name
- Cardiology
- Principal Investigator Name
- Tomas Ripoll Vera
- Principal Investigator Email
- tripoll@hsll.es
- Contact Person Name
- Tomas Ripoll Vera
- Contact Person Email
- tripoll@hsll.es
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Cardiology
- Principal Investigator Name
- Juan Ramon Gimeno Blanes
- Principal Investigator Email
- jgimeno@secardiologia.es
- Contact Person Name
- Juan Ramon Gimeno Blanes
- Contact Person Email
- jgimeno@secardiologia.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Cardiology
- Principal Investigator Name
- Maria Luisa Peña Peña
- Principal Investigator Email
- marialuisacardio@gmail.com
- Contact Person Name
- Maria Luisa Peña Peña
- Contact Person Email
- marialuisacardio@gmail.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Cardiology
- Principal Investigator Name
- Pablo Garcia Pavia
- Principal Investigator Email
- pablogpavia@yahoo.es
- Contact Person Name
- Pablo Garcia Pavia
- Contact Person Email
- pablogpavia@yahoo.es
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Cardiology
- Principal Investigator Name
- Vicente Eduardo Climent Paya
- Principal Investigator Email
- vcliment@coma.es
- Contact Person Name
- Vicente Eduardo Climent Paya
- Contact Person Email
- vcliment@coma.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Cardiology
- Principal Investigator Name
- Esther Zorio Grima
- Principal Investigator Email
- zorio_est@gva.es
- Contact Person Name
- Esther Zorio Grima
- Contact Person Email
- zorio_est@gva.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Cardiology
- Principal Investigator Name
- Javier Limeres Freire
- Principal Investigator Email
- javier.limeres@vallhebron.cat
- Contact Person Name
- Javier Limeres Freire
- Contact Person Email
- javier.limeres@vallhebron.cat
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Cardiology
- Principal Investigator Name
- David Cordero Pereda
- Principal Investigator Email
- davidcorderopereda@gmail.com
- Contact Person Name
- David Cordero Pereda
- Contact Person Email
- davidcorderopereda@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Cardiology
- Principal Investigator Name
- Ana Garcia Alvarez
- Principal Investigator Email
- anagarci@clinic.cat
- Contact Person Name
- Ana Garcia Alvarez
- Contact Person Email
- anagarci@clinic.cat
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Cardiology
- Principal Investigator Name
- Rafael Jesus Hidalgo Urbano
- Principal Investigator Email
- rjhidalur@yahoo.es
- Contact Person Name
- Rafael Jesus Hidalgo Urbano
- Contact Person Email
- rjhidalur@yahoo.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Cardiology
- Principal Investigator Name
- Luis Miguel Rincon Diaz
- Principal Investigator Email
- lmrincond@saludcastillayleon.es
- Contact Person Name
- Luis Miguel Rincon Diaz
- Contact Person Email
- lmrincond@saludcastillayleon.es
Italy
- Earliest CTIS Part Ii Submission Date
- 11-11-2025
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 101
- Number Of Sites
- 6
- Number Of Participants
- 18
Sites
- Site Name
- Istituto Auxologico Italiano
- Department Name
- Unità Operativa di Riabilitazione Cardiologica
- Principal Investigator Name
- Lia Crotti
- Principal Investigator Email
- l.crotti@auxologico.it
- Contact Person Name
- Lia Crotti
- Contact Person Email
- l.crotti@auxologico.it
- Site Name
- Policlinico San Donato S.p.A.
- Department Name
- Cardiologia
- Principal Investigator Name
- Massimo Francesco Piepoli
- Principal Investigator Email
- massimo.piepoli@unimi.it
- Contact Person Name
- Massimo Francesco Piepoli
- Contact Person Email
- massimo.piepoli@unimi.it
- Site Name
- Fondazione Toscana Gabriele Monasterio
- Department Name
- Cardio-Thoracic- UOC Cardiology and cardiovascular medicine
- Principal Investigator Name
- Giancarlo Todiere
- Principal Investigator Email
- gtodiere@ftgm.it
- Contact Person Name
- Giancarlo Todiere
- Contact Person Email
- gtodiere@ftgm.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Advanced Biomedical Sciences Department
- Principal Investigator Name
- Maria Angela Losi
- Principal Investigator Email
- losi@unina.it
- Contact Person Name
- Maria Angela Losi
- Contact Person Email
- losi@unina.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Cardiologia 2 - Insufficienza Cardiaca eTrapianti
- Principal Investigator Name
- Enrico Ammirati
- Principal Investigator Email
- enrico.ammirati@ospedaleniguarda.it
- Contact Person Name
- Enrico Ammirati
- Contact Person Email
- enrico.ammirati@ospedaleniguarda.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Clinica Medica II Piano Cardiologia
- Principal Investigator Name
- Iacopo Olivotto
- Principal Investigator Email
- lacopo.olivotto@unifi.it
- Contact Person Name
- Iacopo Olivotto
- Contact Person Email
- lacopo.olivotto@unifi.it
Sponsor
Primary sponsor
- Full Name
- Imbria Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Development LP
- Responsibilities
- Multiple sponsor duties (codes: 1,10,11,12,13,2,4,5) as listed in third-party duties
- Name
- Icon Clinical Research Limited
- Responsibilities
- Pharmacovigilance; other listed sponsor duties
- Name
- Suvoda LLC
- Responsibilities
- Data management/monitoring role (sponsor duties code: 3 as listed)
- Name
- Medidata Solutions Inc.
- Responsibilities
- Data platform/solutions (sponsor duties code: 7 as listed)
Third parties
- {"country":"United States","full_name":"Yale University","duties_or_roles":"Echocardiography core laboratory","organisation_type":"Educational Institution"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Sponsor duties codes: 1,10,11,12,13,2,4,5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Sponsor duties code: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duties code: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Massachusetts General Hospital","duties_or_roles":"Cardiopulmonary exercise testing core laboratory","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Pharmacovigilance and other safety activities (sponsorDuties include pharmacovigilance)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Ninerafaxstat
- Active Substance
- NINERAFAXSTAT TRIHYDROCHLORIDE MONOHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus 1 (as listed in product dictionary)
- Starting Dose
- 200 mg MR BID
- Dose Levels
- 200 mg MR BID (max daily dose 400 mg)
- Frequency
- BID
- Maximum Dose
- 400 mg per day
- Investigational Product Name
- Tablet, identical in appearance to ninerafaxstat tablets
- Modality
- Other
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