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

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

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.

Study Overview

• Status: Completed
• Conditions: HCV Infection
• Intervention / Treatment: Drug: ABT-333 Tablet; Drug: ABT-333 Capsule; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Waukegan, Illinois, United States, 60085
      • Site Reference ID/Investigator# 19441

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: ABT-333; Drug: Placebo; See Arm Description for more information.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): June 1, 2009

Study Registration Dates

• First Submitted: May 7, 2009
• First Submitted That Met QC Criteria: May 7, 2009
• First Posted (ESTIMATE): May 8, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 13, 2010
• Last Update Submitted That Met QC Criteria: October 12, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Single Ascending Dose (SAD); Bioavailability (BA)
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: M11-032