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

HCV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909311
• Other study ID #: M10-923
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2009
• Last updated: October 11, 2010
• Start date: May 2009

Study information

• Verified date: September 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HCV Infection

Intervention

Drug:
• ABT-450
capsules, QD, 1 dose in each cross-over period
• ritonavir
capsule, QD, 1 dose in each cross-over period

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 19421	Waukegan	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (blood draws, pre- and post-dose)		17 days	No
Primary	Safety and tolerability (ECGs, AEs, vitals, physical exams, routine labs)		30 days	Yes