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:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00895102
First received: May 7, 2009
Last updated: October 12, 2010
Last verified: September 2010
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

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 ] [ Designated as safety issue: No ]
  • To evaluate single dose safety and tolerability of a ABT-333 tablet formulation relative to placebo [ Time Frame: 2 days post dosing ] [ Designated as safety issue: Yes ]
  • To evaluate single dose pharmacokinetics of a ABT-333 tablet formulation [ Time Frame: 2 days post dosing ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: 5 days ] [ Designated as safety issue: No ]

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.
Other Name: Placebo
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.
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;
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Daniel Cohen, MD/Study Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00895102     History of Changes
Other Study ID Numbers: M11-032
Study First Received: May 7, 2009
Last Updated: October 12, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014