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

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01081483
• Collaborator: Abbott Japan Co.,Ltd (Industry)
• Enrollment: 24
• Location: 1
• Arms: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: ABT-072; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Mar 1, 2010
• Actual Primary Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ABT-072 Tablet ABT-072 50 mg Tablet, every day (QD), single ascending doses, groups 1-3	Drug: ABT-072; See arm description for more information
Placebo Comparator: Placebo Placebo Tablet, QD, single doses, groups 1-3	Drug: Placebo; See arm description for more information

Outcome Measures

Primary Outcome Measures

1. 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.

2. Pharmacokinetic profile evaluation [Day 1 to Day 4]

   Single Dose Pharmacokinetic profile evaluation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Kagoshima	Prefecture	Japan

Sponsors and Collaborators

• Abbott
• Abbott Japan Co.,Ltd

Investigators

• Study Director: Kazuko Kobayashi, Abbott Japan Co.,Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01081483
• Other Study ID Numbers: M11-310
• First Posted: Mar 5, 2010
• Last Update Posted: Oct 25, 2010
• Last Verified: Sep 1, 2010

• Keywords provided by , ,: Healthy Volunteers; HCV Infections
• Additional relevant MeSH terms: Hepatitis C

Study Results

No Results Posted as of Oct 25, 2010