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

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ClinicalTrials.gov Identifier: NCT00909311
Recruitment Status : Completed
First Posted : May 28, 2009
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:
Abbott

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
HCV Infection Drug: ABT-450 Drug: ritonavir Phase 1

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

Study Type : Interventional  (Clinical Trial)
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 2009
Actual Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ritonavir
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Pharmacokinetics (blood draws, pre- and post-dose) [ Time Frame: 17 days ]
  2. Safety and tolerability (ECGs, AEs, vitals, physical exams, routine labs) [ Time Frame: 30 days ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909311


Locations
United States, Illinois
Site Reference ID/Investigator# 19421
Waukegan, Illinois, United States, 60085
Sponsors and Collaborators
Abbott
Investigators
Study Director: Isabelle A Gaultier, M.S., IBMH Abbott

Responsible Party: Adebayo Lawal, MD/Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00909311     History of Changes
Other Study ID Numbers: M10-923
First Posted: May 28, 2009    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: September 2009

Keywords provided by Abbott:
Food effect

Additional relevant MeSH terms:
Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors