Phase 1, Open-Label, Randomized, Study of the Safety and Pharmacokinetics of HU6
NCT07170189 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2026-01-21
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.
Conditions
Interventions
- DRUG
-
HU6
HU6 tablet or capsule
Sponsors & Collaborators
-
Rivus Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-10-13
- Primary Completion
- 2025-12-04
- Completion
- 2025-12-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
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