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

Abbott

Status and phase: Completed; Phase 1

Conditions: HCV Infection

Treatments: Drug: ABT-333 Capsule; Drug: ABT-333 Tablet; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00895102

M11-032

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

34 participants in 3 patient groups, including a placebo group

1. ABT-333 Capsule vs ABT-333 Tablet

Active Comparator group

Description:

400mg ABT-333 Tablet, QD, single dose vs eight 50mg ABT-333 Capsules, QD, single dose

Treatment:

Drug: ABT-333 Capsule

Drug: ABT-333 Tablet

2. ABT-333 Tablet

Active Comparator group

Description:

ABT-333 400mg Tablet, QD, single ascending doses (1200mg, 1600mg, 2400mg)

Treatment:

Drug: ABT-333 Tablet

Drug: Placebo

3. Placebo

Placebo Comparator group

Description:

Placebo tablets, QD, single ascending doses

Treatment:

Drug: ABT-333 Tablet

Drug: Placebo