- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00768690
A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333
October 11, 2010 updated by: Abbott
The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-333 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-333
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Waukegan, Illinois, United States, 60085
- Site Reference ID/Investigator# 12701
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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:
- See above for main selection criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
|
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle.
For additional information refer to arm description.
Tablet, see arms for intervention description
Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle.
For additional information refer to arm description.
|
Other: 2
Healthy volunteers, receiving 400 mg ABT-333 or placebo, BID
|
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle.
For additional information refer to arm description.
Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle.
For additional information refer to arm description.
|
Other: 3
Healthy volunteers, receiving 600mg ABT-333 or placebo, BID
|
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle.
For additional information refer to arm description.
Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle.
For additional information refer to arm description.
|
Other: 4
Healthy volunteers, receiving 1000mg ABT-333 or placebo, BID
|
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle.
For additional information refer to arm description.
Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle.
For additional information refer to arm description.
|
Other: 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. |
Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle.
For additional information refer to arm description.
Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle.
For additional information refer to arm description.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Analysis of pharmacokinetic results.
Time Frame: Approximately 1 week.
|
Approximately 1 week.
|
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
Time Frame: Approximately 1 week.
|
Approximately 1 week.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Analysis of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics.
Time Frame: Approximately 1 week.
|
Approximately 1 week.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
October 7, 2008
First Submitted That Met QC Criteria
October 7, 2008
First Posted (Estimate)
October 8, 2008
Study Record Updates
Last Update Posted (Estimate)
October 13, 2010
Last Update Submitted That Met QC Criteria
October 11, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepatitis
- Hepatitis C
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Ketoconazole
Other Study ID Numbers
- M10-687
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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