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CompletedNCT03381664Updated Feb 23, 2018

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

A Phase 1 interventional study of AVP-923 in Healthy Adult Male and Female Volunteers, sponsored by Avanir Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-23.

Sponsored by Avanir Pharmaceuticals · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed 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).

02

Conditions studied

  • Healthy Adult Male and Female Volunteers

Keywords

  • bioavailability
  • pharmacokinetics
  • safety
  • tolerability
  • AVP-923
  • dextromethorphan
  • quinidine
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    AVP-923-20/10 capsule

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

    Drug: AVP-923

  • Experimental
    AVP-923-20/10 via applesauce

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

    Drug: AVP-923

  • Experimental
    AVP-923-20/10 via nasogastric feeding tube

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

    Drug: AVP-923

Interventions

  • DrugAVP-923

    capsule

    Also known as: Dextromethorphan Hydrobromide and Quinidine Sulfate

05

What researchers measure

Primary outcomes

  1. Mean area under the concentration time curve (AUC) from time 0 to time of last measurable concentration (AUC0-t) for the analytes dextromethorphan (DM), dextrorphan (DX), 3-methoxymorphinan (3-MM), and quinidine (Q)

    Time frame: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)

  2. Mean AUC from time 0 to infinity (AUC0-inf) for the analytes DM, DX, 3-MM, and Q

    Time frame: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)

  3. Mean maximum plasma concentration (Cmax) for the analytes DM, DX, 3-MM, and Q

    Time frame: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)

  4. Mean time to maximum plasma concentration (Tmax) for the analytes DM, DX, 3-MM, and Q

    Time frame: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)

  5. Mean apparent terminal elimination half-life (t1/2) for the analytes DM, DX, 3-MM, and Q

    Time frame: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)

  6. Mean apparent elimination rate constant (kel) for the analytes DM, DX, 3-MM, and Q

    Time frame: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)

Secondary outcomes

  1. Number of participants with any adverse event

    Time frame: 3 weeks

  2. Number of participants with any clinically significant clinical laboratory evaluation

    Clinical significance will be determined by the Investigator.

    Time frame: 3 weeks

  3. Number of participants with any clinically significant physical examination evaluation

    Clinical significance will be determined by the Investigator.

    Time frame: 3 weeks

  4. Number of participants with any clinically significant electrocardiogram evaluation

    Clinical significance will be determined by the Investigator.

    Time frame: 3 weeks

  5. Number of participants with any clinically significant vital sign value

    Clinical significance will be determined by the Investigator.

    Time frame: 3 weeks

  6. Number of participants with the indicated score on the Columbia-Suicide Severity Rating Scale (C-SSRS)

    The C-SSRS will be used to prospectively assess suicidal ideation (intensity rated from 1 \[low severity\] to 5 \[high severity\]) and behavior throughout the study.

    Time frame: 3 weeks

06

Study locations

1 site
  • Vince & Associates Clinical Research
    Overland Park, Kansas 66212, United States
07

Registry details

Key details

Study ID
NCT03381664
Lead sponsor
Avanir Pharmaceuticals
Responsible party
Sponsor
First posted
Dec 22, 2017
Start date
Nov 28, 2017
Primary completion
Jan 30, 2018
Completion
Jan 30, 2018
Last update
Feb 23, 2018

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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