NCT02121860

PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers

An Open-Label Pharmacokinetic and Pharmacodynamic Study of a Single Dose of IDN-6556 in Subjects With Hepatic Impairment and in Matched Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Conatus Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with mild, moderate, and severe hepatic impairment (defined as Child-Pugh A, B, and C, respectively) and matched healthy volunteers with normal hepatic function.

Conditions

• Hepatic Impairment
• Liver Diseases
• Digestive System Diseases

Interventions

Type	Name	Description
DRUG	IDN-6556

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-04-24
• Last updated: 2016-02-24
• Results posted: 2016-02-24

Locations

3 sites across 1 country: United States