Clinical trial • Phase I • Other
Clinical trial in Opioid-induced respiratory depression
Phase I trial for Opioid-induced respiratory depression. 130 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Opioid-induced respiratory depression
- Trial Stage
- Phase I
- Drug Modality
- Vaccine
Key dates
- Initial CTIS Submission Date
- 20-10-2025
- First CTIS Authorization Date
- 23-02-2026
Trial design
Phase I trial across 1 site in Netherlands.
- Target Sample Size
- 130
Eligibility
Recruits 130 No vulnerable populations selected; informed consent/assent handling not specified in provided documents..
- Vulnerable Population
- No vulnerable populations selected; informed consent/assent handling not specified in provided documents.
Recruitment
- Planned Sample Size
- 130
- Recruitment Window Months
- 17
- Consent Approach
- Informed consent process not specified in provided documents (who provides consent, age-specific documents, and available languages not described).
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 130
Netherlands
- Earliest CTIS Part Ii Submission Date
- 13-02-2026
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 10
- Number Of Sites
- 1
- Number Of Participants
- 130
Sites
- Site Name
- Centre for Human Drug Research
- Department Name
- n.a.
- Contact Person Name
- Marieke Niesters
- Contact Person Email
- clintrials@chdr.nl
Sponsor
Primary sponsor
- Full Name
- ARMR Sciences Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
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