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
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: 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 August 21, 2014