A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers

NCT02174835 — Phase 1, Completed, 56 participants, Otsuka Pharmaceutical Development & Commercialization, Inc.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

A Phase 1, Single-center, Randomized, Open-label Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide/Quinidine Sulfate) in Healthy Volunteers

Registry	NCT02174835
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, other
Enrollment	56 (Actual)
Sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
Conditions	Healthy
Interventions	AVP-786, AVP-923 (Drug)
Dates	start 2013-09-01, primary completion 2013-11-01, completion 2013-11-01, first posted 2014-06-26, last updated 2026-04-28
Locations	1 site in Australia

-Summary

To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated \[d6\] dextromethorphan hydrobromide \[DM\]/quinidine sulfate \[Q\]) in healthy volunteers.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Cohort A - Period 1	Experimental	Drug: AVP-786	Twice daily dosing orally for 7 days
Cohort A - Period 2	Active comparator	Drug: AVP-923	Twice daily dosing orally for 7 days
Cohort A - Period 3	Experimental	Drug: AVP-786	Twice daily dosing orally for 7 days
Cohort B - Period 1	Experimental	Drug: AVP-786	Twice daily dosing orally for 7 days
Cohort B - Period 2	Active comparator	Drug: AVP-923	Twice daily dosing orally for 7 days
Cohort B - Period 3	Experimental	Drug: AVP-786	Twice daily dosing orally for 7 days

AVP-786 (Drug)
AVP-923 (Drug)

+Outcome measures

Primary outcomes

Plasma concentrations of AVP-786 [7 days]

Secondary outcomes

Incidence of adverse events (AEs) for AVP-786 [7 days]

+Eligibility

Sex: Male, ages: 18 Years to 45 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy adult males
* 18 - 45 years of age
* BMI 18 - 30 kg/m2

Exclusion Criteria:

* History or presence of significant disease
* History of substance abuse and/or alcohol abuse with the past 3 years
* Use of tobacco-containing or nicotine-containing products within 6 months
* Use of any prescription or the over-the-counter medications within 14 days

+Locations (1)

Facility	City	Country	Status
CMAX	Adelaide, South Australia	Australia