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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00909311
First received: May 27, 2009
Last updated: October 11, 2010
Last verified: September 2009

May 27, 2009
October 11, 2010
May 2009
July 2009   (final data collection date for primary outcome measure)
  • Pharmacokinetics (blood draws, pre- and post-dose) [ Time Frame: 17 days ] [ Designated as safety issue: No ]
  • Safety and tolerability (ECGs, AEs, vitals, physical exams, routine labs) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00909311 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
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

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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
HCV Infection
  • Drug: ABT-450
    capsules, QD, 1 dose in each cross-over period
    Other Name: ABT-450
  • Drug: ritonavir
    capsule, QD, 1 dose in each cross-over period
    Other Names:
    • ABT-538
    • ritonavir
    • Norvir
  • Active Comparator: 1
    Non-fasting
    Interventions:
    • Drug: ABT-450
    • Drug: ritonavir
  • Active Comparator: 2
    Fasting
    Interventions:
    • Drug: ABT-450
    • Drug: ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
Not Provided
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00909311
M10-923
No
Adebayo Lawal, MD/Medical Director, Abbott
Abbott
Not Provided
Study Director: Isabelle A Gaultier, M.S., IBMH Abbott
Abbott
September 2009

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