Randomized, Open-label, 2-period Cross-over Study in Healthy Adults to Evaluate the Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir

Abbott1 site in 1 country8 target enrollmentMay 2009

ConditionsHCV Infection

InterventionsABT-450 ritonavir

DrugsABT-450 ritonavir

Overview

Phase: Phase 1
Intervention: ABT-450
Conditions: HCV Infection
Sponsor: Abbott
Enrollment: 8
Locations: 1
Primary Endpoint: Pharmacokinetics (blood draws, pre- and post-dose)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

July 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Abbott

Eligibility Criteria

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;