Clinical trial • Phase I • Other
Vafidemstat for Healthy volunteers
Phase I trial of Vafidemstat for Healthy volunteers. open-label, none/not specified-controlled. 8 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 24-03-2026
- First CTIS Authorization Date
- 30-04-2026
Trial design
open-label, none/not specified-controlled Phase I trial across 1 site in Netherlands.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 8
Eligibility
Recruits 8 No vulnerable populations selected; study population: healthy male participants; consent details not provided..
- Vulnerable Population
- No vulnerable populations selected; study population: healthy male participants; consent details not provided.
Recruitment
- Planned Sample Size
- 8
- Recruitment Window Months
- 1
- Consent Approach
- Informed consent process not described. Participants are healthy male adults; consent/assent documents and languages not provided.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 8
Netherlands
- Earliest CTIS Part Ii Submission Date
- 24-04-2026
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 6
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Pharmaceutical Research Associates Group B.V.
- Department Name
- Program Management
- Contact Person Name
- Renger Tiessen
- Contact Person Email
- renger.tiessen@iconplc.com
Sponsor
Primary sponsor
- Full Name
- Oryzon Genomics S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Contract research organisations
- Name
- Pharmaceutical Research Associates Group B.V.
- Responsibilities
- Program Management; site contact (person: Renger Tiessen, email: renger.tiessen@iconplc.com)
Investigational products
- Investigational Product Name
- [14C]-VAFIDEMSTAT
- Active Substance
- Vafidemstat
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
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