A Study of Single Doses of ABT-072 in Japanese Healthy Male Adults
- Registration Number
- NCT01081483
- Lead Sponsor
- Abbott
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABT-072 Tablet ABT-072 ABT-072 50 mg Tablet, every day (QD), single ascending doses, groups 1-3 Placebo Placebo Placebo Tablet, QD, single doses, groups 1-3
- Primary Outcome Measures
Name Time Method Safety and tolerability assessment Day 1 to Day 4 and Day 15. Safety and tolerability assessment by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring.
Pharmacokinetic profile evaluation Day 1 to Day 4 Single Dose Pharmacokinetic profile evaluation
- Secondary Outcome Measures
Name Time Method