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

A Blinded, Randomized, Placebo-controlled Phase 1 Study in Healthy Male Adults to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single Doses of ABT-072

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01081483

Enrollment

Registered

2010-03-05

Start date

2010-03-31

Completion date

Unknown

Last updated

2010-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Healthy Volunteers, HCV Infections

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.

Interventions

DRUGABT-072

See arm description for more information

DRUGPlacebo

See arm description for more information

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026