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

October 22, 2010 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kagoshima, Japan, 890-0081
        • Site Reference ID/Investigator# 19102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • See above for main selection criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Single dose of 400 mg
Drug: ABT-333
Tablet, see arms for interventional description
Experimental: Group 2
Single dose of 800 mg after safety evolution of Group I
Drug: ABT-333
Tablet, see arms for interventional description
Experimental: Group 3
Single dose of 1200 mg after safety evolution of Group 2
Drug: ABT-333
Tablet, see arms for interventional description
Experimental: Group 4
Single dose of 1600 mg after safety evolution of Group 3
Drug: ABT-333
Tablet, see arms for interventional description
Placebo Comparator: Group 5
Single dose of placebo
Drug: Placebo
Tablet, see arms for interventional description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Daily assessment for 5 days then day 30 or more frequently as needed
To evaluate single dose pharmacokinetics of an ABT-333 tablet formulation
Time Frame: Day 1-3
Day 1-3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Collaborators

Abbott Japan Co.,Ltd

Investigators

  • Study Director: Yutaka Yamamura, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (Estimate)

June 12, 2009

Study Record Updates

Last Update Posted (Estimate)

October 25, 2010

Last Update Submitted That Met QC Criteria

October 22, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M11-023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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