drugset / Trial / NCT07170189

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

NCT07170189 ↗

Phase 1 Completed 59 enrolled Rivus Pharmaceuticals, Inc.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2025-10-13
Primary completion
2025-12-04
Completion
2025-12-04

Drugs

EvaluationDrugModalityDoseRoute
Subject HU6 Unknown 300 mg —
Subject HU6 Unknown 450 mg —

Indications