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

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.

Timeline

Start

2021-08-10

Primary completion

2021-09-29

Completion

2021-09-29

Drugs

Indications

No indication recorded.