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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00895102

Enrollment

Registered

2009-05-08

Start date

2009-04-30

Completion date

Unknown

Last updated

2010-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV Infection

Keywords

Bioavailability (BA), Single Ascending Dose (SAD)

Brief summary

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.

Interventions

DRUGABT-333 Tablet

See Arm Description for more information.

DRUGPlacebo

See Arm Description for more information.

DRUGABT-333 Capsule

See arm description for more information

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026