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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

Page last updated: August 23, 2015

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