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

Phase 1CompletedNCT00919490

Abbott39 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

HCV Infections

Interventions

ABT-333DRUG

Tablet, see arms for interventional description

PlaceboDRUG

Tablet, see arms for interventional description.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has provided written consent. * Subject is in general good health. Exclusion Criteria: * See above for main selection criteria.

Locations (1)

Site Reference ID/Investigator# 19102

Kagoshima, Japan

Outcomes

Primary Outcomes

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

To evaluate single dose pharmacokinetics of an ABT-333 tablet formulation

Time frame: Day 1-3

Data from ClinicalTrials.gov

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