A Study of Single Doses of ABT-072 in Japanese Healthy Male Adults

Abbott24 enrolled

Overview

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of blinded, single ascending oral doses of ABT 072 under non-fasting conditions in healthy adult Japanese male subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hepatitis C

Interventions

ABT-072DRUG

See arm description for more information

PlaceboDRUG

See arm description for more information

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Overall healthy adult Japanese males 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. * 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)

Unnamed facility

Kagoshima, Prefecture, Japan

Outcomes

Primary Outcomes

Safety and tolerability assessment

Safety and tolerability assessment by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring.

Time frame: Day 1 to Day 4 and Day 15.

Pharmacokinetic profile evaluation

Single Dose Pharmacokinetic profile evaluation

Time frame: Day 1 to Day 4

Data from ClinicalTrials.gov

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