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

Abbott52 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Hepatitis C

Interventions

ABT-072DRUG

See Arms information for a detailed description.

PlaceboDRUG

See Arms information for a detailed description.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Site Reference ID/Investigator# 23742

Waukegan, Illinois, United States

Outcomes

Primary Outcomes

To determine the single and multiple dose safety and tolerability of the ABT-072 tablet formulation under non-fasting conditions.

Time frame: Up to 14 days post last dose.

To determine the single and multiple dose safety pharmacokinetics of the ABT-072 tablet formulation under non-fasting conditions.

Time frame: 72 hours post last dose.

Secondary Outcomes

To assess the effect of food on the pharmacokinetics of the ABT-072 tablet formulation.

Time frame: 72 hours post last dose.

Data from ClinicalTrials.gov

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