Study to Assess the Bioavailability, Pharmacokinetics, Safety, and Tolerability of AVP-923 in Healthy Adult Participants

Avanir Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Male and Female Volunteers

Treatments: Drug: AVP-923

Study type: Interventional

Funder types: Industry

Identifiers

NCT03381664

17-AVR-135

Details and patient eligibility

About

This study will be conducted to evaluate the relative bioavailability, pharmacokinetics, safety, and tolerability of AVP-923 (dextromethorphan hydrobromide [DM] and quinidine sulfate [Q] capsules) when the contents of a capsule are administered in applesauce or via a nasogastric feeding tube, compared with administration of a capsule in healthy, fasting, adult participants.

Full description

This is an open-label, single-center, randomized, single-dose, 3-treatment, 3-period, 6-sequence crossover study in healthy adult participants consisting of approximately 7 weeks of treatment. The study population will be limited to extensive metabolizers of cytochrome P450 (CYP) 2D6.

Approximately 18 participants will be randomly assigned to 1 of 6 sequences (ABC, ACB, BAC, BCA, CAB, CBA).

Enrollment: 17 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults, 18 to 65 years of age, inclusive
• Willing to sign informed consent form
• Cytochrome P450 2D6 genotype that confers extensive metabolizer profile (as per documented phenotype interpretation from local laboratory and approval from Avanir)

Exclusion criteria

• History or presence of significant pulmonary, hepatic, renal, hematologic, allergic, endocrine (including diabetes), immunologic, dermatologic, neurologic (including history or presence of seizures or convulsive disorders), psychiatric disease (including history of suicidal ideation or behavior) or any eating disorder deemed clinically significant by the investigator
• History or presence of significant cardiovascular disease, including complete heart block, QT interval corrected for heart rate (QTc) prolongation, and/or torsades de pointes
• History or presence of any gastrointestinal (GI) disease or condition that could compromise participant safety or affect the absorption of study drug, including GI ulcers, GI bleeding, esophageal or gastric varices, and dyspepsia requiring regular (i.e., more frequently than once a month) use of acid-reducing drugs
• Known hypersensitivity/intolerance to dextromethorphan or quinidine
• Participants whom the principal investigator or his delegate deems to be ineligible

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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17 participants in 3 patient groups

AVP-923-20/10 capsule

Experimental group

Description:

Participants will receive a single AVP-923-20/10 (dextromethorphan hydrobromide \[DM\] 20 milligram \[mg\]/quinidine sulfate \[Q\] 10 mg) capsule administered orally.

Treatment:

Drug: AVP-923

AVP-923-20/10 via applesauce

Experimental group

Description:

Participants will receive the contents from a single AVP-923-20/10 capsule mixed and consumed in 1 tablespoon of applesauce.

Treatment:

Drug: AVP-923

AVP-923-20/10 via nasogastric feeding tube

Experimental group

Description:

Participants will receive the contents from a single AVP-923-20/10 capsule solubilized in feeding solution and administered through a nasogastric feeding tube.

Treatment:

Drug: AVP-923