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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
17
capsule
Vince & Associates Clinical Research
Overland Park, Kansas, United States
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)
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)
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)
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)
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)
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)
Number of participants with any adverse event
Time frame: 3 weeks
Number of participants with any clinically significant clinical laboratory evaluation
Clinical significance will be determined by the Investigator.
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Time frame: 3 weeks
Number of participants with any clinically significant physical examination evaluation
Clinical significance will be determined by the Investigator.
Time frame: 3 weeks
Number of participants with any clinically significant electrocardiogram evaluation
Clinical significance will be determined by the Investigator.
Time frame: 3 weeks
Number of participants with any clinically significant vital sign value
Clinical significance will be determined by the Investigator.
Time frame: 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.
Time frame: 3 weeks