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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00909311
Recruitment Status : Completed
First Posted : May 28, 2009
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE May 27, 2009
First Posted Date  ICMJE May 28, 2009
Last Update Posted Date October 13, 2010
Study Start Date  ICMJE May 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2009)
  • Pharmacokinetics (blood draws, pre- and post-dose) [ Time Frame: 17 days ]
  • Safety and tolerability (ECGs, AEs, vitals, physical exams, routine labs) [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
Official Title  ICMJE 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
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.
Detailed Description This is an open-label, randomized, 2 cross-over period fasting and non-fasting study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HCV Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    Non-fasting
    Interventions:
    • Drug: ABT-450
    • Drug: ritonavir
  • Active Comparator: 2
    Fasting
    Interventions:
    • Drug: ABT-450
    • Drug: ritonavir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2009)
8
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00909311
Other Study ID Numbers  ICMJE M10-923
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adebayo Lawal, MD/Medical Director, Abbott
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Isabelle A Gaultier, M.S., IBMH Abbott
PRS Account Abbott
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP