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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081483
• Other study ID #: M11-310
• Status: Completed
• Phase: Phase 1
• First received: March 4, 2010
• Last updated: October 22, 2010
• Start date: March 2010

Study information

• Verified date: September 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• ABT-072
See arm description for more information
• Placebo
See arm description for more information

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Abbott Japan Co.,Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability assessment	Safety and tolerability assessment by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring.	Day 1 to Day 4 and Day 15.	Yes
Primary	Pharmacokinetic profile evaluation	Single Dose Pharmacokinetic profile evaluation	Day 1 to Day 4	No