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

Abbott

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: ABT-072; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01081483

M11-310

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

ABT-072 Tablet

Active Comparator group

Description:

ABT-072 50 mg Tablet, every day (QD), single ascending doses, groups 1-3

Treatment:

Drug: ABT-072

Placebo

Placebo Comparator group

Description:

Placebo Tablet, QD, single doses, groups 1-3

Treatment:

Drug: Placebo