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NCT05042986 · ClinicalTrials.gov registry record · Early Phase 1
A Study of the Absorption, Metabolism, and Excretion of [14C]-SKI-O-703 Following a Single Oral Dose in Healthy Male Subjects
A Early Phase 1 study, sponsored by Oscotec.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
NCT05042986: Completed Early Phase 1 study, sponsored by Oscotec.
NCT05042986 is a Early Phase 1 study that has completed, run by Oscotec. The registered enrollment target is 8 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05042986, a Early Phase 1 study, has completed, sponsored by Oscotec.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This will be a Phase I, open-label, nonrandomized, single dose study in healthy male subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the study site on Day -1 and be confined to the study site until at least Day 8. On the morning of Day 1, all subjects will receive a single oral dose of \[14C\]-SKI-O-703. Subjects will be discharged if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections, ≥ 90% mass balance recovery, and ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods. If discharge criteria are not met by Day 8, subjects will remain in the study site up to Day 15.
Interventions
- DRUG .[14C]-SKI-O-703
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-08-10 |
| Est. Completion | 2021-09-29 |
| Phase | Early Phase 1 |
What the finished NCT05042986 record still lists
NCT05042986 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 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which .[14C]-SKI-O-703 is the first listed.
NCT05042986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05042986 about?
NCT05042986 is a clinical study titled "A Study of the Absorption, Metabolism, and Excretion of [14C]-SKI-O-703 Following a Single Oral Dose in Healthy Male Subjects". This will be a Phase I, open-label, nonrandomized, single dose study in healthy male subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the study site on Day -1 and be confined ...
What is the current status of trial NCT05042986?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2021-08-10. Estimated completion is 2021-09-29.
What interventions are being tested in trial NCT05042986?
The interventions under investigation include: .[14C]-SKI-O-703 (DRUG).
Who is sponsoring clinical trial NCT05042986?
This trial is sponsored by Oscotec, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05042986's enrollment target sits among peer trials
8 1783rd of 2000 higher than 176 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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