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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00931281
First received: June 5, 2009
Last updated: October 11, 2010
Last verified: September 2010
  Purpose

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple doses of an experimental hepatitis C virus (HCV) protease inhibitor with ritonavir in healthy volunteers.


Condition Intervention Phase
HCV Infection
Drug: ABT-450
Drug: ritonavir
Drug: Placebo for ABT-450
Drug: Placebo for ritonavir
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Blinded, Randomized, Nonfasting, Placebo-Controlled Study in Healthy Adults to Evaluate Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Ascending Doses 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: 38
Study Start Date: June 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
ABT-450/ritonavir
Drug: ABT-450
capsules, QD or BID, 14 days, ascending doses
Other Name: ABT-450
Drug: ritonavir
capsules, QD or BID, 14 days, ascending doses
Other Names:
  • ABT-538
  • ritonavir
  • Norvir
Placebo Comparator: 2
Placebo for ABT-450/placebo for ritonavir
Drug: Placebo for ABT-450
capsule, QD or BID, 14 days
Other Name: placebo
Drug: Placebo for ritonavir
capsule, QD or BID, 14 days
Other Name: placebo

Detailed Description:

This is a multiple ascending dose, non-fasting, open label, randomized 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 within the 6-month period prior to study drug administration
  • donation or loss of 550mL 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: NCT00931281

Locations
United States, Illinois
Site Reference ID/Investigator# 18161
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: Isabelle Gaultier, Scientific Director, Abbott
ClinicalTrials.gov Identifier: NCT00931281     History of Changes
Other Study ID Numbers: M10-861
Study First Received: June 5, 2009
Last Updated: October 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Multiple Ascending Doses

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 April 17, 2014