Single and Multiple Dose Evaluation of ABT-072 and to Evaluate the Effect of Food on the Pharmacokinetics of ABT-072

Abbott

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: ABT-072; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00982826

M11-057

Details and patient eligibility

About

To assess the safety, tolerability and pharmacokinetics of the ABT-072 tablet formulation administered as a single dose and then administered as multiple doses for 7 days. The effect of food on the safety, tolerability and pharmacokinetics of the ABT-072 tablet will also be evaluated.

Full description

The study consists of two substudies. Substudy 1 is a two-period, single ascending dose (SAD) and multiple ascending dose (MAD) blinded, randomized, placebo-controlled, non-fasting study. Designated groups that participate in Period 1 (SAD) will also participate in Period 2 (MAD). Substudy 2 is an open-label, randomized two-period, crossover study to examine the effect of food on the pharmacokinetics of ABT 072.

Enrollment: 52 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overall healthy subjects, non-childbearing females included.

Exclusion criteria

• Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
• Pregnant or breast-feeding female.
• Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
• Positive screen for drugs of abuse, alcohol, or cotinine.
• 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 within the 6-month period preceding study drug administration.

Trial design

52 participants in 5 patient groups

1

Experimental group

Description:

ABT-072 tablet single ascending dose

Treatment:

Drug: ABT-072

2

Experimental group

Description:

Placebo tablet

Treatment:

Drug: Placebo

3

Experimental group

Description:

ABT-072 tablet administered under non-fasting conditions.

Treatment:

Drug: ABT-072

4

Experimental group

Description:

ABT-072 tablet administered under fasting conditions

Treatment:

Drug: ABT-072

5

Experimental group

Description:

ABT-072 tablet multiple ascending dose

Treatment:

Drug: ABT-072