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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00909636
First received: May 27, 2009
Last updated: October 11, 2010
Last verified: September 2010

May 27, 2009
October 11, 2010
May 2009
July 2009   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • Values for the pharmacokinetic parameters of ABT-333 will be evaluated after pre- and post-dose blood draws. [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00909636 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of the ABT-333 Tablet
A Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333 in Healthy Adults

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HCV Infection
  • Drug: ABT-333
    See arm description for more information
    Other Name: ABT-333
  • Drug: Placebo
    See arm description for more information
    Other Name: Placebo
  • Active Comparator: 1. ABT-333 Tablet
    Three 400mg ABT-333 Tablets, BID
    Intervention: Drug: ABT-333
  • Active Comparator: 2. ABT-333 Tablet
    Four 400mg ABT-333 Tablets, BID
    Intervention: Drug: ABT-333
  • Placebo Comparator: 3. Placebo
    Three or four placebo tablets, BID
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Not Provided
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00909636
M11-031
No
Daniel Cohen, MD/Study Medical Director, Abbott
Abbott
Not Provided
Study Director: Daniel Cohen, MD Abbott
Abbott
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP