NCT01081483

Brief Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of blinded, single ascending oral doses of ABT 072 under non-fasting conditions in healthy adult Japanese male subjects.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 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

Study Start

First participant enrolled

March 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

October 25, 2010

Status Verified

September 1, 2010

Enrollment Period

3 months

First QC Date

March 4, 2010

Last Update Submit

October 22, 2010

Conditions

Hepatitis C

Keywords

Healthy VolunteersHCV Infections

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability assessment

    Safety and tolerability assessment by the evaluation of vital signs, ECGs, physical exams, clinical lab testing and adverse event monitoring.

    Day 1 to Day 4 and Day 15.

  • Pharmacokinetic profile evaluation

    Single Dose Pharmacokinetic profile evaluation

    Day 1 to Day 4

Study Arms (2)

ABT-072 Tablet

ACTIVE COMPARATOR

ABT-072 50 mg Tablet, every day (QD), single ascending doses, groups 1-3

Drug: ABT-072

Placebo

PLACEBO COMPARATOR

Placebo Tablet, QD, single doses, groups 1-3

Drug: Placebo

Interventions

ABT-072DRUG

See arm description for more information

ABT-072 Tablet
PlaceboDRUG

See arm description for more information

Placebo

Eligibility Criteria

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

You may qualify if:

  • Overall healthy adult Japanese males

You may not qualify if:

  • Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
  • Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
  • Positive screen for drugs of abuse, alcohol, or cotinine.
  • Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
  • Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kagoshima, Prefecture, Japan

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

ABT-072

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Kazuko Kobayashi

    Abbott Japan Co.,Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 4, 2010

First Posted

March 5, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2010

Last Updated

October 25, 2010

Record last verified: 2010-09

Locations

JP(1)