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

Phase 1

Completed

• Conditions: HCV Infection
• Interventions: Drug: ABT-450; Drug: ritonavir

• Registration Number: NCT00909311
• Lead Sponsor: Abbott

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-27
• Study First Submitted QC: 2009-05-27
• Study First Posted: 2009-05-28
• Primary Completion: 2009-07
• Status Verified: 2009-09
• Last Update Submitted: 2010-10-11
• Last Update Posted: 2010-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	ritonavir	Non-fasting
2	ritonavir	Fasting
1	ABT-450	Non-fasting
2	ABT-450	Fasting

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (blood draws, pre- and post-dose)	17 days
Safety and tolerability (ECGs, AEs, vitals, physical exams, routine labs)	30 days

Trial Locations

Locations (1)

Site Reference ID/Investigator# 19421; 🇺🇸 Waukegan, Illinois, United States