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

HCV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895102
• Other study ID #: M11-032
• Status: Completed
• Phase: Phase 1
• First received: May 7, 2009
• Last updated: October 12, 2010
• Start date: April 2009

Study information

• Verified date: September 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• HCV Infection

Intervention

Drug:
• ABT-333 Tablet
See Arm Description for more information.
• Placebo
See Arm Description for more information.
• ABT-333 Capsule
See arm description for more information

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 19441	Waukegan	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine relative bioavailability of the ABT-333 tablet formulation compared to the FIH capsule formulation		2 days post dosing	No
Primary	To evaluate single dose safety and tolerability of a ABT-333 tablet formulation relative to placebo		2 days post dosing	Yes
Primary	To evaluate single dose pharmacokinetics of a ABT-333 tablet formulation		2 days post dosing	No
Primary	Pharmacokinetics		5 days	No