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

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ClinicalTrials.gov Identifier: NCT00919490
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : October 25, 2010
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
HCV Infections Drug: ABT-333 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : June 2009
Primary Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Dasabuvir
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. To evaluate single dose pharmacokinetics of an ABT-333 tablet formulation [ Time Frame: Day 1-3 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kazuhiko Sawa, Abbott Japan Co., Ltd.
ClinicalTrials.gov Identifier: NCT00919490     History of Changes
Other Study ID Numbers: M11-023
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: September 2010

Keywords provided by Abbott:
Healthy Volunteers