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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
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

Enrollment: 8
Study Start Date: May 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Non-fasting
 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: 2
Fasting
 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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Adebayo Lawal, MD/Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00909311     History of Changes
Other Study ID Numbers: M10-923
Study First Received: May 27, 2009
Last Updated: October 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Food effect

Additional relevant MeSH terms:
Ritonavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013