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NCT03795519 · ClinicalTrials.gov registry record · Phase 1
A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Olinciguat in Healthy Male Volunteers
A Phase 1 study of Healthy Volunteers, sponsored by Cyclerion Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT03795519: Completed Phase 1 study of Healthy Volunteers, sponsored by Cyclerion Therapeutics.
NCT03795519 is a Phase 1 study of Healthy Volunteers that has completed, run by Cyclerion Therapeutics. The registered enrollment target is 8 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03795519, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Cyclerion Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective is to characterize the pharmacokinetics (PK) of olinciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of \[14C\]-olinciguat.
Conditions Studied
Interventions
- DRUG [14C]-olinciguat
Study Locations (1)
Wisconsin
- Covance Clinical Research Unit Inc. - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-01-17 |
| Est. Completion | 2019-02-27 |
| Phase | Phase 1 |
What the finished NCT03795519 record still lists
NCT03795519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which [14C]-olinciguat is the first listed.
NCT03795519 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03795519 about?
NCT03795519 is a clinical study titled "A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Olinciguat in Healthy Male Volunteers". The primary objective is to characterize the pharmacokinetics (PK) of olinciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of \[14C\]-olinciguat.
What is the current status of trial NCT03795519?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2019-01-17. Estimated completion is 2019-02-27.
What conditions does trial NCT03795519 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT03795519?
The interventions under investigation include: [14C]-olinciguat (DRUG).
Who is sponsoring clinical trial NCT03795519?
This trial is sponsored by Cyclerion Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03795519 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03795519's enrollment target sits among peer trials
8 269th of 283 higher than 7 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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