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
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: 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 July 20, 2014