Study in Healthy Adults to Evaluate Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir

Abbott

Status and phase

Completed

Phase 1

Conditions

HCV Infection

Treatments

Drug: Placebo for ritonavir

Drug: Placebo for ABT-450

Drug: ABT-450

Drug: ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00931281

M10-861

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple doses of an experimental hepatitis C virus (HCV) protease inhibitor with ritonavir in healthy volunteers.

Full description

This is a multiple ascending dose, non-fasting, open label, randomized study.

Enrollment

38 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

overall healthy subjects
non-childbearing potential females included

Exclusion criteria

history of significant sensitivity to any drug
positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
history of gastrointestinal issues or procedures
history of seizures, diabetes or cancer (except basal cell carcinoma)
clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder
use of tobacco or nicotine-containing products within the 6-month period prior to study drug administration
donation or loss of 550mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration
abnormal screening laboratory results that are considered clinically significant by the investigator
current enrollment in another clinical study
previous enrollment in this study
recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol
pregnant or breastfeeding female
requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis