A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333
NCT ID: NCT00768690
Last Updated: 2010-10-13
Study Results
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.
COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2008-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Healthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole
ABT-333
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.
ketoconazole
Tablet, see arms for intervention description
placebo
Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
2
Healthy volunteers, receiving 400 mg ABT-333 or placebo, BID
ABT-333
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.
placebo
Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
3
Healthy volunteers, receiving 600mg ABT-333 or placebo, BID
ABT-333
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.
placebo
Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
4
Healthy volunteers, receiving 1000mg ABT-333 or placebo, BID
ABT-333
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.
placebo
Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
5
Healthy volunteers, receiving 1600mg ABT-333 or placebo, BID\*
\*After review of the data from previous groups, and in accordance with the protocol, this arm was not dosed.
ABT-333
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.
placebo
Capsule or powder drug substance from the capsule powder 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-333
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.
ketoconazole
Tablet, see arms for intervention description
placebo
Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Abbott
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site Reference ID/Investigator# 12701
Waukegan, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M10-687
Identifier Type: -
Identifier Source: org_study_id