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

Sponsor

Avanir Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT02402595

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AVP-923 Drug: AVP-786 Drug: Itraconazole	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

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	Drug: AVP-923 Drug: Itraconazole Other Names: Sporanex
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	Drug: AVP-786 Drug: Itraconazole Other Names: Sporanex
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	Drug: AVP-786 Drug: Itraconazole Other Names: Sporanex
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	Drug: AVP-923 Drug: Itraconazole Other Names: Sporanex

Outcome Measures

Primary Outcome Measures

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

Incidence of adverse events (AEs) for AVP-923 and itraconazole [16 Days]
Incidence of adverse events (AEs) for AVP-786 and itraconazole [16 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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