Clinical trial • Phase I • Gastroenterology
naronapride for Idiopathic gastroparesis | Diabetic gastroparesis
Phase I trial of naronapride for Idiopathic gastroparesis | Diabetic gastroparesis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Idiopathic gastroparesis | Diabetic gastroparesis
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-02-2025
- First CTIS Authorization Date
- 25-04-2025
Trial design
Randomised, comparator: healthy subjects (non-drug comparator)-controlled Phase I trial across 3 sites in Germany, Poland, Belgium.
- Randomised
- Yes
- Comparator
- Comparator: healthy subjects (non-drug comparator)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 60
Eligibility
Recruits 60 Vulnerable population selected; no further details on consent or assent provided in the available record..
- Vulnerable Population
- Vulnerable population selected; no further details on consent or assent provided in the available record.
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 18
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 60
Germany
- Earliest CTIS Part Ii Submission Date
- 22-04-2025
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 316
- Number Of Sites
- 1
- Number Of Participants
- 24
Sites
- Site Name
- SocraTec R&D Concepts in Drug Research and Development GmbH
- Department Name
- CPU
- Contact Person Name
- Ulrike Burkhardt
- Contact Person Email
- info@socratec-pharma.de
Poland
- Earliest CTIS Part Ii Submission Date
- 28-08-2025
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 186
- Number Of Sites
- 1
- Number Of Participants
- 26
Sites
- Site Name
- Biokinetica S.A.
- Department Name
- n.a.
- Contact Person Name
- Monika Tomaszewska-Kiecana
- Contact Person Email
- Monika.Kiecana@biokinetica.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 13-08-2025
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 223
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- UZ Leuven
- Department Name
- Gastroenterology
- Contact Person Name
- Jan Tack
- Contact Person Email
- jan.tack@kuleuven.be
Sponsor
Primary sponsor
- Full Name
- Dr. Falk Pharma GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- naronapride
- Active Substance
- naronapride
- Modality
- Small molecule
- Dose Levels
- three different doses
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