Clinical Trials/NCT02121860

NCT02121860

Completed

Phase 1

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

Conatus Pharmaceuticals Inc.3 sites in 1 country37 target enrollmentApril 2014

ConditionsHepatic Impairment Liver Diseases Digestive System Diseases

InterventionsIDN-6556

DrugsIDN-6556

Overview

Phase: Phase 1
Intervention: IDN-6556
Conditions: Hepatic Impairment
Sponsor: Conatus Pharmaceuticals Inc.
Enrollment: 37
Locations: 3
Primary Endpoint: AUC
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

July 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Conatus Pharmaceuticals Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All Subjects:
•Male or female subjects 18 years of age or older, able to provide written informed consent, understand and comply with all scheduled visits, and other requirements of the study
•Body mass index (BMI) 18.0 - 40.0 kg/m2 and body weight \>45 kg
•Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from Screening to one month after the last dose of study drug
•Matched Healthy Volunteers:
•Medically healthy as determined by the Investigator
•Supine blood pressure ≤145/90 mmHg
•No significant uncontrolled systemic or major illness that, in the opinion of the Investigator, would preclude the subject from participating in and completing the study
•Demographically comparable to subjects with hepatic impairment as follows:
•Mean body weight within ±15 kg

Exclusion Criteria

•All Subjects:
•Known infection with human immunodeficiency virus (HIV) upon serological testing
•Evidence of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, renal, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
•Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pharmacokinetics of the investigational medicinal product (e.g., inflammatory bowel disease, resections of the small or large intestine, etc.)
•History of febrile illness within 5 days prior to dosing Note: Subjects can be rescreened once afebrile and more than 5 days have elapsed since the febrile illness.
•Known ongoing drug abuse within one month prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during Screening and/or at Day -1
•Subjects with active or history of malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
•Dosing in another clinical trial within 30 days prior to the study drug administration
•If female: known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
•Matched Healthy Volunteers:

Arms & Interventions

Chil-Pugh Class A

All subjects with mild hepatic impairment received a single 50 mg oral dose of IDN-6556

Intervention: IDN-6556

Chil-Pugh Class B

All subjects with moderate hepatic impairment received a single 50 mg oral dose of IDN-6556

Intervention: IDN-6556

Chil-Pugh Class C

All subjects with severe hepatic impairment received a single 50 mg oral dose of IDN-6556

Intervention: IDN-6556

Normal Hepatic Function

All healthy volunteers subjects received a single 50 mg oral dose of IDN-6556

Intervention: IDN-6556

Outcomes

Primary Outcomes

AUC

Time Frame: 48 Hours

Area under the plasma concentration curve (AUC) to 12 hours post-dose (AUC0-12); AUC to the last observed plasma concentration (AUClast);

Cmax

Time Frame: 48 Hours

Maximum concentration (Cmax)

Secondary Outcomes

Levels of cCK18/M30(predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose)
Levels of Caspase 3/7 RLU(predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose)