Back to resultsA Study of Single Dose of ABT-333 in Healthy Male Adults
Primary Purpose
HCV Infections
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
ABT-333
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for HCV Infections focused on measuring Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Subject has provided written consent.
- Subject is in general good health.
Exclusion Criteria:
- See above for main selection criteria.
Sites / Locations
- Site Reference ID/Investigator# 19102
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Group 1
Group 2
Group 3
Group 4
Group 5
Arm Description
Single dose of 400 mg
Single dose of 800 mg after safety evolution of Group I
Single dose of 1200 mg after safety evolution of Group 2
Single dose of 1600 mg after safety evolution of Group 3
Single dose of placebo
Outcomes
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
To evaluate single dose pharmacokinetics of an ABT-333 tablet formulation
Secondary Outcome Measures
Full Information
NCT ID
NCT00919490
First Posted
May 28, 2009
Last Updated
October 22, 2010
Sponsor
Abbott
Collaborators
Abbott Japan Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00919490
Brief Title
A Study of Single Dose of ABT-333 in Healthy Male Adults
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
Collaborators
Abbott Japan Co.,Ltd
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCV Infections
Keywords
Healthy Volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Single dose of 400 mg
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Single dose of 800 mg after safety evolution of Group I
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Single dose of 1200 mg after safety evolution of Group 2
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Single dose of 1600 mg after safety evolution of Group 3
Arm Title
Group 5
Arm Type
Placebo Comparator
Arm Description
Single dose of placebo
Intervention Type
Drug
Intervention Name(s)
ABT-333
Intervention Description
Tablet, see arms for interventional description
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet, see arms for interventional description.
Primary Outcome Measure Information:
Title
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
Title
To evaluate single dose pharmacokinetics of an ABT-333 tablet formulation
Time Frame
Day 1-3
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject has provided written consent.
Subject is in general good health.
Exclusion Criteria:
See above for main selection criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yutaka Yamamura
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 19102
City
Kagoshima
ZIP/Postal Code
890-0081
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study of Single Dose of ABT-333 in Healthy Male Adults
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