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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 is a Early Phase 1 study that has completed, run by Oscotec. The registered enrollment target is 8 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05042986
The ClinicalTrials.gov registry entry for NCT05042986 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oscotec, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which .[14C]-SKI-O-703 is the first listed.
NCT05042986 reports 0 study locations.
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.
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