NCT06325930

A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6

An Open-Label Phase 1 Study in Healthy Adult Male Subjects to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6 Following Single-Dose Oral Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Rivus Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single dose of \[14C\]-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing.

Detailed description

This is a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single dose of \[14C\]-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing. Healthy, adult males aged 18 to 55, inclusive, who have provided written informed consent, will be screened, and subjects who meet all eligibility criteria may be enrolled into the study within 28 days of Screening. Approximately 8 eligible subjects will be admitted on Day -1, and baseline assessments will be completed. On Day 1, 8 subjects will receive a single dose of \[14C\]-HU6 in a fed state. If ≥ 85% (mean of all subjects) of the 14C label has been recovered in samples collected and analyzed through 336 hours after dosing and the mean of individual 14C recovery is \< 1% on each of 2 consecutive days, all subjects will be discharged from the Pharmaron Clinical Pharmacology Center (CPC) on Day 15 after completion of all 336-hour timepoint assessments.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	[14C]-HU6	\[14C\]-HU6 following a single dose of HU6 in healthy, adult male subjects

Timeline

• Start date: 2024-03-26
• Primary completion: 2024-05-07
• Completion: 2024-05-07
• First posted: 2024-03-22
• Last updated: 2024-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study