Clinical Trials Logo
  1. Home
  2. Obese
  3. NCT05433506

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
See also
  Status Clinical Trial Phase
Completed NCT04105075 - COPD in Obese Patients
Completed NCT04099654 - The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery N/A
Recruiting NCT05857150 - Exercise Response in Humans With Obesity
Completed NCT03532672 - Early Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity N/A
Completed NCT02618486 - The Effects of Obesity on Non Surgical Periodontal Therapy N/A
Completed NCT02086448 - Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP) N/A
Completed NCT01724515 - PGC-1 and Mitochondrial Dysfunction in Diabetes N/A
Completed NCT01724502 - Mitochondrial Dysfunction in Diabetes N/A
Active, not recruiting NCT01634204 - Efficacy of a Web-based Weight Loss Program Phase 2
Completed NCT01479933 - Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes N/A
Completed NCT01421589 - Growth Hormone Treatment on Phosphocreatine Recovery in Obesity N/A
Completed NCT03528304 - Native Women's Wellness: Contingency Management for Tobacco Cessation and Weight Loss N/A
Completed NCT01467817 - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI) N/A
Completed NCT01726647 - Metabolism Associated With Abdominal Fat Mass Distribution N/A
Active, not recruiting NCT02125149 - The Expecting Study N/A
Completed NCT05737927 - Pharmacodynamics and Pharmacokinetics of Different Glucose Bead Formulations in Obese Healthy Subjects Phase 1
Completed NCT02871882 - Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus Phase 2
Completed NCT03298464 - Study of NGM313 in Obese Participants Phase 1
Completed NCT05061173 - Comparison of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults N/A
Completed NCT02919176 - Brown Fat Activation Study Early Phase 1