COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00931281
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : October 13, 2010
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
HCV Infection Drug: ABT-450 Drug: ritonavir Drug: Placebo for ABT-450 Drug: Placebo for ritonavir Phase 1

Detailed Description:
This is a multiple ascending dose, non-fasting, open label, randomized study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2009
Actual Primary Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ritonavir

Arm Intervention/treatment
Active Comparator: 1
Drug: ABT-450
capsules, QD or BID, 14 days, ascending doses

Drug: ritonavir
capsules, QD or BID, 14 days, ascending doses
Other Names:
  • ABT-538
  • 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

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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT00931281

Layout table for location information
United States, Illinois
Site Reference ID/Investigator# 18161
Waukegan, Illinois, United States, 60085
Sponsors and Collaborators
Layout table for investigator information
Study Director: Isabelle A Gaultier, M.S., IBMH Abbott

Layout table for additonal information
Responsible Party: Isabelle Gaultier, Scientific Director, Abbott Identifier: NCT00931281    
Other Study ID Numbers: M10-861
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: September 2010
Keywords provided by Abbott:
Multiple Ascending Doses
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
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