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

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00909311
Collaborator
(none)
8
Enrollment
1
Location
2
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
May 1, 2009
Actual Primary Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Non-fasting

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

Drug: ritonavir
capsule, QD, 1 dose in each cross-over period
Other Names:
  • ABT-538
  • Norvir

    		•
    Active Comparator: 2

    Fasting

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

    Drug: ritonavir
    capsule, QD, 1 dose in each cross-over period
    Other Names:
  • ABT-538
  • Norvir

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (blood draws, pre- and post-dose) [17 days]

    2. Safety and tolerability (ECGs, AEs, vitals, physical exams, routine labs) [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Reference ID/Investigator# 19421 Waukegan Illinois United States 60085

    Sponsors and Collaborators

    • Abbott

    Investigators

    • Study Director: Isabelle A Gaultier, M.S., IBMH, Abbott

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00909311
    Other Study ID Numbers:
    • M10-923
    First Posted:
    May 28, 2009
    Last Update Posted:
    Oct 13, 2010
    Last Verified:
    Sep 1, 2009
    Keywords provided by , ,
    Food effect
    Additional relevant MeSH terms:
    Hepatitis C
    Ritonavir

    Study Results

    No Results Posted as of Oct 13, 2010