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Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1

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.
 
ClinicalTrials.gov Identifier: NCT00850044
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : November 20, 2017
Sponsor:
Information provided by:
AbbVie

Brief Summary:
The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Nonfasting Study in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Doses of ABT-450 With and Without Ritonavir
Study Start Date : February 2009
Actual Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C
Drug Information available for: Ritonavir

Arm Intervention/treatment
Active Comparator: 1
ABT-450
Drug: ABT-450
capsules,QD, one dose, see Arm Descriptions for more information

Placebo Comparator: 2
Placebo for ABT-450
Drug: placebo for ABT-450
capsules, QD, one dose
Other Name: placebo

Active Comparator: 3
ABT-450/ritonavir
Drug: ABT-450
capsules,QD, one dose, see Arm Descriptions for more information

Drug: ritonavir
capsules, QD, one dose, escalating doses, see Arm Descriptions for more information
Other Names:
  • ABT-538
  • Norvir

Placebo Comparator: 4
Placebo for ABT-450/placebo for ritonavir
Drug: placebo for ABT-450
capsules, QD, one dose
Other Name: placebo

Drug: Placebo for ritonavir
capsules, QD, one dose
Other Name: placebo




Primary Outcome Measures :
  1. Pharmacokinetics (blood draws, pre- and post-dose) [ Time Frame: 4 days ]
  2. Safety and Tolerability (ECGs, AEs, vitals, physical exams, routine labs) [ Time Frame: 10 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00850044


Locations
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United States, Illinois
Site Reference ID/Investigator# 15981
Waukegan, Illinois, United States, 60085
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: Adebayo A Lawal, MD Abbott

Publications of Results:
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Responsible Party: Adebayo Lawal, M.D./Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00850044    
Other Study ID Numbers: M10-749
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: September 2010
Keywords provided by AbbVie:
FIH
SAD
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Ritonavir
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