Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AVP-923; Drug: AVP-786; Drug: Itraconazole

• Registration Number: NCT02402595
• Lead Sponsor: Avanir Pharmaceuticals

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.

Detailed Description

A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.

Study Timeline

• Study First Submitted: 2015-02-26
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-03-30
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1 - Period 1	AVP-923	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
Sequence 1 - Period 1	Itraconazole	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
Sequence 2 - Period 2 (after 3-week washout)	AVP-923	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
Sequence 1 - Period 2 (after 3-week washout)	AVP-786	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
Sequence 2 - Period 1	AVP-786	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
Sequence 1 - Period 2 (after 3-week washout)	Itraconazole	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
Sequence 2 - Period 2 (after 3-week washout)	Itraconazole	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
Sequence 2 - Period 1	Itraconazole	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs) for AVP-786 and itraconazole	16 Days
Incidence of adverse events (AEs) for AVP-923 and itraconazole	16 Days

Trial Locations

Locations (1)

Vince and Associates Clinical Research, Inc.; 🇺🇸 Overland Park, Kansas, United States