NCT06486558

Relative Bioavailability Study of HU6

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Rivus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a 2-part study. Part 1 will assess the relative bioavailability of the new 450 mg tablet test formulation compared to the 150 mg capsule reference formulation (3 x 150 mg). Part 1 dosing will be conducted in the fasted state. Part 2 will assess the effect of food (and fat content) on the pharmacokinetics of the 450 mg tablet test formulation.

Detailed description

This is a 2-part study. Part 1 is an open-label, randomized, Latin-square 2x2 crossover study. Forty subjects will be randomized to treatment sequence to determine the order in which they will receive the tablet (test) or capsule (reference) formulation in the fasted state. Fourteen days will separate dosing in Period 1 and Period 2. After Part 1 is completed, the Part 1 pharmacokinetic blood samples will be shipped for bioanalysis. Study conduct will proceed to Part 2. Fourteen days will separate dosing in Part 1 Period 2 and Part 2 Period 1. Part 2 is an open-label, randomized, Latin-square 2x2 crossover study. The approximately 40 subjects who participated in Part 1 will be randomized to treatment sequence to determine the order in which they will receive the tablet (test) formulation in the high fat fed state or the low fat fed state. Fourteen days will separate dosing in Period 1 and Period 2

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HU6 450 mg Tablet	new 450 mg tablet test formulation
DRUG	HU6 150 mg Capsules x 3 (Total dose = 450 mg)	150 mg capsule reference formulation (3 x 150 mg).

Timeline

• Start date: 2024-07-24
• Primary completion: 2024-11-15
• Completion: 2024-12-15
• First posted: 2024-07-03
• Last updated: 2025-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study