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

Abbott

Status and phase

Completed

Phase 1

Conditions

HCV Infection

Treatments

Drug: ritonavir

Drug: ABT-450

Study type

Interventional

Funder types

Industry

Identifiers

NCT00909311

M10-923

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of food on pharmacokinetics, safety and tolerability of an experimental Hepatitis C Virus (HCV) protease inhibitor with ritonavir in healthy volunteers.

Full description

This is an open-label, randomized, 2 cross-over period fasting and non-fasting study.

Enrollment

8 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 with the 6-month period prior to study drug administration;
donation or loss of 550 mL 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