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
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 April 17, 2014