A Study of Single Dose of ABT-333 in Healthy Male Adults

This study has been completed.
Sponsor:
Collaborator:
Abbott Japan Co.,Ltd
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00919490
First received: May 28, 2009
Last updated: October 22, 2010
Last verified: September 2010
  Purpose

The objectives of this study is to assess the safety, tolerability, and pharmacokinetics of blind, escalating, single, oral doses of ABT-333 under nonfasting conditions in healthy male adult in Japan.


Condition Intervention Phase
HCV Infections
Drug: ABT-333
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Phase 1 Study in Healthy Male Adults to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single Dose of ABT-333

Further study details as provided by Abbott:

Primary Outcome Measures:
  • To assess single dose safety and tolerability of an ABT-333 tablet formulation relative to placebo by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring [ Time Frame: Daily assessment for 5 days then day 30 or more frequently as needed ] [ Designated as safety issue: Yes ]
  • To evaluate single dose pharmacokinetics of an ABT-333 tablet formulation [ Time Frame: Day 1-3 ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: June 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Single dose of 400 mg
Drug: ABT-333
Tablet, see arms for interventional description
Other Name: ABT-333
Experimental: Group 2
Single dose of 800 mg after safety evolution of Group I
Drug: ABT-333
Tablet, see arms for interventional description
Other Name: ABT-333
Experimental: Group 3
Single dose of 1200 mg after safety evolution of Group 2
Drug: ABT-333
Tablet, see arms for interventional description
Other Name: ABT-333
Experimental: Group 4
Single dose of 1600 mg after safety evolution of Group 3
Drug: ABT-333
Tablet, see arms for interventional description
Other Name: ABT-333
Placebo Comparator: Group 5
Single dose of placebo
Drug: Placebo
Tablet, see arms for interventional description.
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:

  • Subject has provided written consent.
  • Subject is in general good health.

Exclusion Criteria:

  • See above for main selection criteria.
  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: NCT00919490

Locations
Japan
Site Reference ID/Investigator# 19102
Kagoshima, Japan, 890-0081
Sponsors and Collaborators
Abbott
Abbott Japan Co.,Ltd
Investigators
Study Director: Yutaka Yamamura Abbott
  More Information

No publications provided

Responsible Party: Kazuhiko Sawa, Abbott Japan Co., Ltd.
ClinicalTrials.gov Identifier: NCT00919490     History of Changes
Other Study ID Numbers: M11-023
Study First Received: May 28, 2009
Last Updated: October 22, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:
Healthy Volunteers

ClinicalTrials.gov processed this record on September 18, 2014