NCT00895102

Brief Summary

The purpose of this study is to determine the bioavailability, pharmacokinetic and safety profiles of an experimental Hepatitis C virus (HCV) polymerase inhibitor in healthy volunteers.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
34

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

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Last Updated

October 13, 2010

Status Verified

September 1, 2010

Enrollment Period

2 months

First QC Date

May 7, 2009

Last Update Submit

October 12, 2010

Conditions

HCV Infection

Keywords

Bioavailability (BA)Single Ascending Dose (SAD)

Outcome Measures

Primary Outcomes (4)

  • To determine relative bioavailability of the ABT-333 tablet formulation compared to the FIH capsule formulation

    2 days post dosing

  • To evaluate single dose safety and tolerability of a ABT-333 tablet formulation relative to placebo

    2 days post dosing

  • To evaluate single dose pharmacokinetics of a ABT-333 tablet formulation

    2 days post dosing

  • Pharmacokinetics

    5 days

Study Arms (3)

1. ABT-333 Capsule vs ABT-333 Tablet

ACTIVE COMPARATOR

400mg ABT-333 Tablet, QD, single dose vs eight 50mg ABT-333 Capsules, QD, single dose

Drug: ABT-333 TabletDrug: ABT-333 Capsule

2. ABT-333 Tablet

ACTIVE COMPARATOR

ABT-333 400mg Tablet, QD, single ascending doses (1200mg, 1600mg, 2400mg)

Drug: ABT-333 TabletDrug: Placebo

3. Placebo

PLACEBO COMPARATOR

Placebo tablets, QD, single ascending doses

Drug: ABT-333 TabletDrug: Placebo

Interventions

ABT-333 TabletDRUG

See Arm Description for more information.

Also known as: ABT-333
1. ABT-333 Capsule vs ABT-333 Tablet2. ABT-333 Tablet3. Placebo
PlaceboDRUG

See Arm Description for more information.

2. ABT-333 Tablet3. Placebo
ABT-333 CapsuleDRUG

See arm description for more information

1. ABT-333 Capsule vs ABT-333 Tablet

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • overall healthy subjects;
  • non-childbearing potential females included

You may not qualify if:

  • history of significant sensitivity to any drug;
  • positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab;
  • history of gastrointestinal issues or procedures;
  • history of seizures, diabetes or cancer (except basal cell carcinoma);
  • 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 with the 6-month period prior to study drug administration;
  • donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration;
  • abnormal screening laboratory results that are considered clinically significant by the investigator;
  • current enrollment in another clinical study;
  • previous enrollment in this study;
  • recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol;
  • pregnant or breastfeeding female;
  • requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 19441

Waukegan, Illinois, 60085, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

dasabuvir

Condition Hierarchy (Ancestors)

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

Study Officials

  • Daniel Cohen, MD

    Abbott

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 8, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2009

Last Updated

October 13, 2010

Record last verified: 2010-09

Locations

US(1)