Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Abbott; AbbVie
• Treatments: Ritonavir

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

• 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