Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts
DDI
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
1 other identifier
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedApril 28, 2026
April 1, 2026
4 months
February 26, 2015
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in plasma concentration of AVP-923 after dosing in combination with itraconazole
16 Days
Change in plasma concentration of AVP-786 after dosing in combination with itraconazole
16 Days
Secondary Outcomes (2)
Incidence of adverse events (AEs) for AVP-923 and itraconazole
16 Days
Incidence of adverse events (AEs) for AVP-786 and itraconazole
16 Days
Study Arms (4)
Sequence 1 - Period 1
EXPERIMENTALAVP-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
Sequence 1 - Period 2 (after 3-week washout)
EXPERIMENTALAVP-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
Sequence 2 - Period 1
EXPERIMENTALAVP-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
Sequence 2 - Period 2 (after 3-week washout)
EXPERIMENTALAVP-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
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, 66212, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2015
First Posted
March 30, 2015
Study Start
March 1, 2015
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
April 28, 2026
Record last verified: 2026-04