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Completed

NCT Number: NCT00919490

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

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.

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Key information

Conditions

HCV Infections

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 19102

Kagoshima, 890-0081, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • See above for main selection criteria.

Treatment and study plan

ABT-333

Drug

Tablet, see arms for interventional description

Placebo

Drug

Tablet, see arms for interventional description.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

  • Abbott Japan Co.,Ltd

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
First posted
Jun 12, 2009
Registry last updated
Oct 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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