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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01081483
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : October 25, 2010
Abbott Japan Co.,Ltd
Information provided by:

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 Type : Interventional  (Clinical Trial)
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 : March 2010
Actual Primary Completion Date : June 2010

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

Primary Outcome Measures :
  1. Safety and tolerability assessment [ Time Frame: 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 [ Time Frame: Day 1 to Day 4 ]
    Single Dose Pharmacokinetic profile evaluation

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01081483

Kagoshima, Prefecture, Japan
Sponsors and Collaborators
Abbott Japan Co.,Ltd
Study Director: Kazuko Kobayashi Abbott Japan Co.,Ltd

Responsible Party: Kazuhiko Sawa, Abbott Japan Co., Ltd Identifier: NCT01081483     History of Changes
Other Study ID Numbers: M11-310
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: September 2010

Keywords provided by Abbott:
Healthy Volunteers
HCV Infections

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases