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
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, see Learn About Clinical Studies.

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 July 20, 2014