NCT00919490

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Last Updated

October 25, 2010

Status Verified

September 1, 2010

Enrollment Period

2 months

First QC Date

May 28, 2009

Last Update Submit

October 22, 2010

Conditions

HCV Infections

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (5)

Group 1

EXPERIMENTAL

Single dose of 400 mg

Drug: ABT-333

Group 2

EXPERIMENTAL

Single dose of 800 mg after safety evolution of Group I

Drug: ABT-333

Group 3

EXPERIMENTAL

Single dose of 1200 mg after safety evolution of Group 2

Drug: ABT-333

Group 4

EXPERIMENTAL

Single dose of 1600 mg after safety evolution of Group 3

Drug: ABT-333

Group 5

PLACEBO COMPARATOR

Single dose of placebo

Drug: Placebo

Interventions

ABT-333DRUG

Tablet, see arms for interventional description

Group 1Group 2Group 3Group 4
PlaceboDRUG

Tablet, see arms for interventional description.

Group 5

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • See above for main selection criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 19102

Kagoshima, 890-0081, Japan

Location

MeSH Terms

Interventions

dasabuvir

Study Officials

  • Yutaka Yamamura

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 12, 2009

Study Start

June 1, 2009

Primary Completion

August 1, 2009

Last Updated

October 25, 2010

Record last verified: 2010-09

Locations

JP(1)