MedDataX Logo

A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C

NCT ID: NCT00890318

Last Updated: 2010-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HCV Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Healthy volunteers, receiving daily dose of 80 mg ABT-072 or placebo, QD for 10 days; and on Study Day 11 receiving a single dose of 80 mg ABT-072 or placebo + 400 mg ketoconazole

Group Type OTHER

ABT-072

Intervention Type DRUG

Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.

ketoconazole

Intervention Type OTHER

Tablet, see Arm Description for intervention information.

Placebo

Intervention Type DRUG

Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.

2

Healthy volunteers, receiving 160 mg ABT-072 or placebo, QD for 10 days.

Group Type OTHER

ABT-072

Intervention Type DRUG

Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.

Placebo

Intervention Type DRUG

Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.

3

Healthy volunteers, receiving 320 mg ABT-072 or placebo, QD for 10 days.

Group Type OTHER

ABT-072

Intervention Type DRUG

Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.

Placebo

Intervention Type DRUG

Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABT-072

Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.

Intervention Type DRUG

ketoconazole

Tablet, see Arm Description for intervention information.

Intervention Type OTHER

Placebo

Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Main Selection Criteria for Healthy Volunteers:

* Subject has provided written consent.
* Subject is in general good health.
* If female, subject is postmenopausal for at least 2 years or surgically sterile.
* If female, subject is not pregnant and is not breast-feeding.
* Male or female between 18 and 55 years old, inclusive.
* If male, subject must be surgically sterile or practicing at least 1 method of birth control.
* Body Mass Index (BMI) is 18 to 29, inclusive.

Exclusion Criteria

* Use of medications including over the counter and vitamines.
* Abuse of alcohol, drugs, or nicotine.
* Current diseases or disorders.
* History of cardiac disease.
* If after consideration by the investigator, for any reason, that you are unsuitable to receive ABT-072.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abbott

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel Cohen, MD

Role: STUDY_DIRECTOR

Abbott

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Abbott Clinical Pharmaceutical Research Unit

Waukegan, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M10-705

Identifier Type: -

Identifier Source: org_study_id