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

Phase 1

Completed

• Conditions: HCV Infections
• Interventions: Drug: Placebo; Drug: ABT-333

• Registration Number: NCT00919490
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-28
• Study Start: 2009-06
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Primary Completion: 2009-08
• Status Verified: 2010-09
• Last Update Submitted: 2010-10-22
• Last Update Posted: 2010-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 39

Inclusion Criteria

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

Exclusion Criteria

• See above for main selection criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 5	Placebo	Single dose of placebo
Group 2	ABT-333	Single dose of 800 mg after safety evolution of Group I
Group 1	ABT-333	Single dose of 400 mg
Group 3	ABT-333	Single dose of 1200 mg after safety evolution of Group 2
Group 4	ABT-333	Single dose of 1600 mg after safety evolution of Group 3

Primary Outcome Measures

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

Trial Locations

Locations (1)

Site Reference ID/Investigator# 19102; 🇯🇵 Kagoshima, Japan