- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02402595
Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts (DDI)
March 16, 2017 updated by: Avanir Pharmaceuticals
A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, Drug Interaction Study Between AVP-923 and Itraconazole, and Between AVP-786 and Itraconazole in Healthy Adult Subjects
The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor, itraconazole, on the steady-state PK of AVP-923 and AVP-786.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.
Study Type
Interventional
Enrollment (Actual)
24
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
-
-
Kansas
-
Overland Park, Kansas, United States, 66212
- Vince and Associates Clinical Research, Inc.
-
-
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:
- Healthy adult males and females, 18 to 55 years of age
- Body Mass Index (BMI) ≥19 and ≤30 kg/m2 (for both males and females)
Exclusion Criteria:
- History or presence of significant disease
- History of substance abuse or dependence (except caffeine), or treatment for substance use disorder(s) within the year prior to screening or within 6 months for nicotine including e-cigarettes
- Use of any tobacco-containing or nicotine-containing products within 6 months prior to the first dose
- Use of any prescription or the over-the-counter medications within 14 days
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sequence 1 - Period 1
AVP-923 and placebo matching AVP-786- BID Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
|
Other Names:
|
Experimental: Sequence 1 - Period 2 (after 3-week washout)
AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
|
Other Names:
|
Experimental: Sequence 2 - Period 1
AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
|
Other Names:
|
Experimental: Sequence 2 - Period 2 (after 3-week washout)
AVP-923 and placebo matching AVP-786- BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in plasma concentration of AVP-923 after dosing in combination with itraconazole
Time Frame: 16 Days
|
16 Days
|
Change in plasma concentration of AVP-786 after dosing in combination with itraconazole
Time Frame: 16 Days
|
16 Days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events (AEs) for AVP-923 and itraconazole
Time Frame: 16 Days
|
16 Days
|
Incidence of adverse events (AEs) for AVP-786 and itraconazole
Time Frame: 16 Days
|
16 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin Kankam, MD, PhD, MPH, Vince and Associates Clinical Research Inc.
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
March 1, 2015
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
February 26, 2015
First Submitted That Met QC Criteria
March 27, 2015
First Posted (Estimate)
March 30, 2015
Study Record Updates
Last Update Posted (Actual)
March 20, 2017
Last Update Submitted That Met QC Criteria
March 16, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- 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
- Itraconazole
Other Study ID Numbers
- 15-AVP-786-103
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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