Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HCV Infection
Intervention: ABT-450 (Drug); ritonavir (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s): Isabelle A Gaultier, M.S., IBMH, Study Director, Affiliation: Abbott
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetics (blood draws, pre- and post-dose)Safety and tolerability (ECGs, AEs, vitals, physical exams, routine labs)
Detailed description:
This is an open-label, randomized, 2 cross-over period fasting and non-fasting study.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Site Reference ID/Investigator# 19421, Waukegan, Illinois 60085, United States
Additional Information
Starting date: May 2009
Last updated: October 11, 2010
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