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
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
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 21, 2014