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
  Purpose

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 Intervention Phase
HCV Infection
Drug: ABT-333
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: May 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. ABT-333 Tablet
Three 400mg ABT-333 Tablets, BID
Drug: ABT-333
See arm description for more information
Other Name: ABT-333
Active Comparator: 2. ABT-333 Tablet
Four 400mg ABT-333 Tablets, BID
Drug: ABT-333
See arm description for more information
Other Name: ABT-333
Placebo Comparator: 3. Placebo
Three or four placebo tablets, BID
Drug: Placebo
See arm description for more information
Other Name: Placebo

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909636

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

No publications provided

Responsible Party: Daniel Cohen, MD/Study Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00909636     History of Changes
Other Study ID Numbers: M11-031
Study First Received: May 27, 2009
Last Updated: October 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
multiple ascending doses (MAD)

ClinicalTrials.gov processed this record on April 17, 2014