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

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

ABT-072

Placebo

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Healthy Volunteers, HCV Infections

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ABT-072 Tablet

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Safety and tolerability assessment

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

Pharmacokinetic profile evaluation

Single Dose Pharmacokinetic profile evaluation

Secondary Outcome Measures

Full Information

NCT ID

NCT01081483

First Posted

March 4, 2010

Last Updated

October 22, 2010

Sponsor

Abbott

Collaborators

Abbott Japan Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01081483

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott

Collaborators

Abbott Japan Co.,Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

Healthy Volunteers, HCV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABT-072 Tablet

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ABT-072

Intervention Description

See arm description for more information

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

See arm description for more information

Primary Outcome Measure Information:

Title

Safety and tolerability assessment

Description

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.

Title

Pharmacokinetic profile evaluation

Description

Single Dose Pharmacokinetic profile evaluation

Time Frame

Day 1 to Day 4

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kazuko Kobayashi

Organizational Affiliation

Abbott Japan Co.,Ltd

Official's Role

Study Director

Facility Information:

City

Kagoshima

State/Province

Prefecture

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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