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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00919490

Enrollment

Registered

2009-06-12

Start date

2009-06-30

Completion date

Unknown

Last updated

2010-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV Infections

Keywords

Healthy Volunteers

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.

Interventions

DRUGABT-333

Tablet, see arms for interventional description

DRUGPlacebo

Tablet, see arms for interventional description.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* See above for main selection criteria.

Design outcomes

Primary

Measure	Time frame
To evaluate single dose pharmacokinetics of an ABT-333 tablet formulation	Day 1-3
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026