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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of the ABT-333 Tablet

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: NCT00909636
Recruitment Status : Completed
First Posted : May 28, 2009
Last Update Posted : October 13, 2010
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of escalating multiple doses of the ABT-333 tablet formulation in healthy adult subjects.

Condition or disease Intervention/treatment Phase
HCV Infection Drug: ABT-333 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333 in Healthy Adults
Study Start Date : May 2009
Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Dasabuvir
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1. ABT-333 Tablet
Three 400mg ABT-333 Tablets, BID
Drug: ABT-333
See arm description for more information
Active Comparator: 2. ABT-333 Tablet
Four 400mg ABT-333 Tablets, BID
Drug: ABT-333
See arm description for more information
Placebo Comparator: 3. Placebo
Three or four placebo tablets, BID
Drug: Placebo
See arm description for more information

Outcome Measures

Primary Outcome Measures :
  1. To assess multiple dose safety and tolerability of an ABT-333 tablet formulation relative to placebo by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring. [ Time Frame: 10 days ]
  2. Values for the pharmacokinetic parameters of ABT-333 will be evaluated after pre- and post-dose blood draws. [ Time Frame: 10 days ]

Eligibility Criteria

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

Inclusion Criteria:

  • overall healthy subjects between the ages of 18 to 55 years old;
  • if female, subject must be either postmenopausal for at least 2 years or surgically sterile;
  • females must have negative results for pregnancy tests performed;
  • if male, subject must be surgically sterile or practicing at least 1 of the following methods of birth control:

    • partner(s) using IUD,
    • partner(s) using oral, injected or implanted methods of hormonal contraceptives,
    • subject and/or partner(s) using double-barrier method;
  • Body Mass Index is 18 to 29, inclusive

Exclusion Criteria:

  • history of significant sensitivity to any drug;
  • positive test for HAV IgM, HBsAg, HCV Ab or 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;
  • clinically significant abnormal screening laboratory analyses and ECGs:

    • ALT > ULN,
    • AST > ULN,
    • ECG with QTcF>450 msec in females and >430 msec in males,
    • or ECG with 2nd or 3rd degree atrioventricular block;
  • 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 or use within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication;
  • use of known inhibitors or inducers of cytochrome P450 3A or cytochrome P450 2C8 within 1 month prior to study drug administration;
  • positive screen for drugs of abuse, alcohol, or cotinine;
  • receipt of any drug by injection within 30 days prior to study drug administration;
  • receipt of any investigational product within a time period equal to 10 half-lives of the product or a minimum of 6 weeks prior to study drug administration;
  • consumption of alcohol within 48 hours prior to study drug administration;
  • consumption of grapefruit, grapefruit products, star fruit, or star fruit products within the 72-hour period prior to study drug administration;
  • consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-333;
  • history of cardiac disease, including family history of long-QT syndrome or unexplained sudden death.
Contacts and Locations

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): NCT00909636

United States, Illinois
Site Reference ID/Investigator# 20081
Waukegan, Illinois, United States, 60085
Sponsors and Collaborators
Study Director: Daniel Cohen, MD Abbott
More Information

Responsible Party: Daniel Cohen, MD/Study Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00909636     History of Changes
Other Study ID Numbers: M11-031
First Posted: May 28, 2009    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: September 2010

Keywords provided by Abbott:
multiple ascending doses (MAD)