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

This study has been completed.
Sponsor:
Collaborator:
Abbott Japan Co.,Ltd
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01081483
First received: March 4, 2010
Last updated: October 22, 2010
Last verified: September 2010
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Safety and tolerability assessment [ Time Frame: Day 1 to Day 4 and Day 15. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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
Other Name: ABT-072
Placebo Comparator: Placebo
Placebo Tablet, QD, single doses, groups 1-3
Drug: Placebo
See arm description for more information
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  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 ClinicalTrials.gov identifier: NCT01081483

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

No publications provided

Responsible Party: Kazuhiko Sawa, Abbott Japan Co., Ltd
ClinicalTrials.gov Identifier: NCT01081483     History of Changes
Other Study ID Numbers: M11-310
Study First Received: March 4, 2010
Last Updated: October 22, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:
Healthy Volunteers
HCV Infections

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

ClinicalTrials.gov processed this record on September 22, 2014