NCT05433506

Safety and Pharmacokinetics of HU6

A Phase 1, Two-Part Study to Assess the Safety and Pharmacokinetics of Tablet and Capsule Formulations of HU6 in Obese Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Rivus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Part 1 is an open-label, randomized, Latin-square 2x2 crossover study. Twelve subjects will be randomized (1:1) to treatment sequence to determine the order in which they will receive the tablet or capsule formulation in Period 1 and Period 2. Part 2 is an open-label study of up to 4 single, ascending dose levels of HU6 administered as the tablet formulation. Eight subjects will be enrolled to participate in all of the ascending study periods.

Detailed description

Part 1 is an open-label, randomized, Latin-square 2x2 crossover study. Twelve subjects will be randomized (1:1) to treatment sequence to determine the order in which they will receive the tablet or capsule formulation in Period 1 and Period 2. There will be a minimum 10 day washout period between dosing in Period 1 and Period 2. Part 2 is an open-label study of up to 4 single, ascending dose levels of HU6 administered as the tablet formulation. Eight subjects will be enrolled to participate in all of the ascending study periods. There will be a minimum 14-day washout period between dosing in each study period. The washout is longer in Part 2 to allow time for pharmacokinetic analyses and data review between study periods.

Conditions

• Obese

Interventions

Type	Name	Description
DRUG	HU6 Tablet	Six subjects will receive a tablet formulation.
DRUG	HU6 Capsule	Six subjects will receive the capsule formulation

Timeline

• Start date: 2022-09-15
• Primary completion: 2023-01-30
• Completion: 2023-03-15
• First posted: 2022-06-27
• Last updated: 2023-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study