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Safety and Pharmacokinetics of HU6

Obese Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05433506
Study type Interventional
Source Rivus Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 1
Start date September 15, 2022
Completion date March 15, 2023
View Details
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