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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02174835

Enrollment

Registered

2014-06-26

Start date

2013-09-01

Completion date

2013-11-01

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pharmacokinetics, Healthy Volunteers, deuterated dextromethorphan, deuterated dextromethorphan with quinidine

Brief 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.

Interventions

DRUGAVP-786

DRUGAVP-923

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Plasma concentrations of AVP-786	7 days

Secondary

Measure	Time frame
Incidence of adverse events (AEs) for AVP-786	7 days

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026