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Completed

NCT Number: NCT00895102

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

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.

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Key information

Conditions

HCV Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 19441

Waukegan, Illinois, 60085, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABT-333 Tablet

Drug

See Arm Description for more information.

Other names: ABT-333

Placebo

Drug

See Arm Description for more information.

ABT-333 Capsule

Drug

See arm description for more information

Primary outcomes

  1. To determine relative bioavailability of the ABT-333 tablet formulation compared to the FIH capsule formulation

    Time frame: 2 days post dosing

  2. To evaluate single dose safety and tolerability of a ABT-333 tablet formulation relative to placebo

    Time frame: 2 days post dosing

  3. To evaluate single dose pharmacokinetics of a ABT-333 tablet formulation

    Time frame: 2 days post dosing

  4. Pharmacokinetics

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
First posted
May 8, 2009
Registry last updated
Oct 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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