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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVP-923-20/10 capsule | Experimental | Participants will receive a single AVP-923-20/10 (dextromethorphan hydrobromide [DM] 20 milligram [mg]/quinidine sulfate [Q] 10 mg) capsule administered orally. |
|
| AVP-923-20/10 via applesauce | Experimental | Participants will receive the contents from a single AVP-923-20/10 capsule mixed and consumed in 1 tablespoon of applesauce. |
|
| AVP-923-20/10 via nasogastric feeding tube | Experimental | Participants will receive the contents from a single AVP-923-20/10 capsule solubilized in feeding solution and administered through a nasogastric feeding tube. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVP-923 | Drug | capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration) | |
| Mean AUC from time 0 to infinity (AUC0-inf) for the analytes DM, DX, 3-MM, and Q | pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration) | |
| Mean maximum plasma concentration (Cmax) for the analytes DM, DX, 3-MM, and Q | pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration) | |
| Mean time to maximum plasma concentration (Tmax) for the analytes DM, DX, 3-MM, and Q | pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration) | |
| Mean apparent terminal elimination half-life (t1/2) for the analytes DM, DX, 3-MM, and Q | pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration) | |
| Mean apparent elimination rate constant (kel) for the analytes DM, DX, 3-MM, and Q | pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with any adverse event | 3 weeks | |
| Number of participants with any clinically significant clinical laboratory evaluation | Clinical significance will be determined by the Investigator. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince & Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
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| ID | Term |
|---|---|
| C507057 | dextromethorphan - quinidine combination |
| D003915 | Dextromethorphan |
| D011802 | Quinidine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| 3 weeks |
| Number of participants with any clinically significant physical examination evaluation | Clinical significance will be determined by the Investigator. | 3 weeks |
| Number of participants with any clinically significant electrocardiogram evaluation | Clinical significance will be determined by the Investigator. | 3 weeks |
| Number of participants with any clinically significant vital sign value | Clinical significance will be determined by the Investigator. | 3 weeks |
| 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. | 3 weeks |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002930 | Cinchona Alkaloids |
| D011812 | Quinuclidines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |