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Bioavailability of ABT-333 Tablet Versus First in Human (FIH) Capsule Formulation and Safety, Tolerability and PK Study of Single Doses of ABT-333 in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00895102
First Posted: May 8, 2009
Last Update Posted: October 13, 2010
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.
Information provided by:
Abbott
  Purpose
The purpose of this study is to determine the bioavailability, pharmacokinetic and safety profiles of an experimental Hepatitis C virus (HCV) polymerase inhibitor in healthy volunteers.

Condition Intervention Phase
HCV Infection Drug: ABT-333 Tablet Drug: Placebo Drug: ABT-333 Capsule Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: An Open-Label Randomized, Crossover Study to Evaluate the Bioavailability of ABT-333 Tablets Versus Capsules, and A Double-blind, Randomized, Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Ascending Doses of ABT-333 Tablets Versus Placebo in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • To determine relative bioavailability of the ABT-333 tablet formulation compared to the FIH capsule formulation [ Time Frame: 2 days post dosing ]
  • To evaluate single dose safety and tolerability of a ABT-333 tablet formulation relative to placebo [ Time Frame: 2 days post dosing ]
  • To evaluate single dose pharmacokinetics of a ABT-333 tablet formulation [ Time Frame: 2 days post dosing ]
  • Pharmacokinetics [ Time Frame: 5 days ]

Enrollment: 34
Study Start Date: April 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. ABT-333 Capsule vs ABT-333 Tablet
400mg ABT-333 Tablet, QD, single dose vs eight 50mg ABT-333 Capsules, QD, single dose
Drug: ABT-333 Tablet
See Arm Description for more information.
Other Name: ABT-333
Drug: ABT-333 Capsule
See arm description for more information
Active Comparator: 2. ABT-333 Tablet
ABT-333 400mg Tablet, QD, single ascending doses (1200mg, 1600mg, 2400mg)
Drug: ABT-333 Tablet
See Arm Description for more information.
Other Name: ABT-333
Drug: Placebo
See Arm Description for more information.
Placebo Comparator: 3. Placebo
Placebo tablets, QD, single ascending doses
Drug: ABT-333 Tablet
See Arm Description for more information.
Other Name: ABT-333
Drug: Placebo
See Arm Description for more information.

  Eligibility

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
  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): NCT00895102


Locations
United States, Illinois
Site Reference ID/Investigator# 19441
Waukegan, Illinois, United States, 60085
Sponsors and Collaborators
Abbott
Investigators
Study Director: Daniel Cohen, MD Abbott
  More Information

Responsible Party: Daniel Cohen, MD/Study Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00895102     History of Changes
Other Study ID Numbers: M11-032
First Submitted: May 7, 2009
First Posted: May 8, 2009
Last Update Posted: October 13, 2010
Last Verified: September 2010

Keywords provided by Abbott:
Bioavailability (BA)
Single Ascending Dose (SAD)