This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Abbott Japan Co.,Ltd
Information provided by:
Abbott Identifier:
First received: March 4, 2010
Last updated: October 22, 2010
Last verified: September 2010
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 Intervention Phase
Hepatitis C Drug: ABT-072 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (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

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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.

  • Pharmacokinetic profile evaluation [ Time Frame: Day 1 to Day 4 ]
    Single Dose Pharmacokinetic profile evaluation

Enrollment: 24
Study Start Date: March 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01081483

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

Responsible Party: Kazuhiko Sawa, Abbott Japan Co., Ltd Identifier: NCT01081483     History of Changes
Other Study ID Numbers: M11-310
Study First Received: March 4, 2010
Last Updated: October 22, 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 processed this record on July 27, 2017