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

Avanir Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AVP-923; Drug: AVP-786; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02402595

15-AVP-786-103

Details and patient eligibility

About

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.

Full description

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 4 patient groups

Sequence 1 - Period 1

Experimental group

Description:

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

Treatment:

Drug: Itraconazole

Drug: AVP-923

Sequence 1 - Period 2 (after 3-week washout)

Experimental group

Description:

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

Treatment:

Drug: Itraconazole

Drug: AVP-786

Sequence 2 - Period 1

Experimental group

Description:

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

Treatment:

Drug: Itraconazole

Drug: AVP-786

Sequence 2 - Period 2 (after 3-week washout)

Experimental group

Description:

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

Treatment:

Drug: Itraconazole

Drug: AVP-923