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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014