Clinical trial • Phase I • Gastroenterology
linaprazan glurate for Erosive gastroesophageal reflux disease | Gastroesophageal reflux
Phase I trial of linaprazan glurate for Erosive gastroesophageal reflux disease | Gastroesophageal reflux. 129 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Erosive gastroesophageal reflux disease | Gastroesophageal reflux
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 07-08-2024
- First CTIS Authorization Date
- 16-08-2024
Trial design
Phase I trial across 1 site in Sweden.
- Target Sample Size
- 129
Recruitment
- Planned Sample Size
- 129
- Recruitment Window Months
- 47
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 129
Sweden
- Earliest CTIS Part Ii Submission Date
- 11-07-2024
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 613
- Number Of Sites
- 1
- Number Of Participants
- 129
Sites
- Site Name
- CTC Clinical Trial Consultants AB
- Department Name
- CTC Clinical Trial Consultants AB
- Contact Person Name
- Erik Rein Hedin
- Contact Person Email
- erik.rein-hedin@ctc-ab.se
Sponsor
Primary sponsor
- Full Name
- Cinclus Pharma Holding AB (publ)
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- linaprazan glurate
- Active Substance
- linaprazan glurate
- Modality
- Small molecule
- Routes Of Administration
- oral (tablets)
- Route
- oral
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