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

HCV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919490
• Other study ID #: M11-023
• Status: Completed
• Phase: Phase 1
• First received: May 28, 2009
• Last updated: October 22, 2010
• Start date: June 2009

Study information

• Verified date: September 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Subject has provided written consent.

• Subject is in general good health.

Exclusion Criteria:

• See above for main selection criteria.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HCV Infections

Intervention

Drug:
• ABT-333
Tablet, see arms for interventional description
• Placebo
Tablet, see arms for interventional description.

Locations

Country	Name	City	State
Japan	Site Reference ID/Investigator# 19102	Kagoshima

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Abbott Japan Co.,Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	To evaluate single dose pharmacokinetics of an ABT-333 tablet formulation		Day 1-3	No