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A Study of the Absorption, Metabolism, and Excretion of [14C]-SKI-O-703 Following a Single Oral Dose in Healthy Male Subjects

NCT05042986 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-04-20

No results posted yet for this 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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

.[14C]-SKI-O-703

Single oral dose of 200 mg (100 μCi in 200 mg salt \[0.5 μCi/mg as salt\], equivalent to 100 μCi in 142 mg active \[0.7 μCi/mg as active\]) of \[14C\]-SKI-O-703 containing approximately 100 μCi of \[14C\]-SKI-O-703 per capsule after an overnight fast.

Sponsors & Collaborators

  • Oscotec Inc.

    lead INDUSTRY

Principal Investigators

  • Study Chair · Oscotec Inc.

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-10
Primary Completion
2021-09-29
Completion
2021-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05042986 on ClinicalTrials.gov