NCT07170189

Phase 1, Open-Label, Randomized, Study of the Safety and Pharmacokinetics of HU6

A Phase 1, Open-label, Randomized, Five-Part Study to Assess the Pharmacokinetics and Safety of Tablet and Capsule Formulations of HU6 in Overweight Participants.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Rivus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a five-part study being conducted to evaluate the safety, tolerability and pharmacokinetics of the HU6 tablet and capsule formulations at steady state in the fed and fasted state for HU6 450 mg once daily (QD) dose (as single or multiple tablets) or HU6 300 mg twice daily (BID) (supplied as two 150 mg tablets) or HU6 150 mg drug substance in a capsule × 3 (450 mg total dose) QD or HU6 150 mg granulated blend in a capsule × 3 (450 mg total dose) QD.

Detailed description

This is a five-part study being conducted to evaluate the safety, tolerability and pharmacokinetics of the HU6 tablet and capsule formulations at steady state in the fed and fasted state for 450 mg once daily (QD) dose (as single or multiple tablets) or 300 mg twice daily (BID) (supplied as two 150 mg tablets) or HU6 150 mg drug substance in a capsule × 3 (450 mg total dose) QD or HU6 150 mg granulated blend in a capsule × 3 (450 mg total dose) QD. Population pharmacokinetic (popPK) modeling indicated a potential difference in PK profile when multiple dose units are administered versus a single dose unit in tablet and capsule formulations.

Conditions

• Overweight

Interventions

Type	Name	Description
DRUG	HU6	HU6 tablet or capsule

Timeline

• Start date: 2025-10-13
• Primary completion: 2025-12-04
• Completion: 2025-12-04
• First posted: 2025-09-12
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study