NCT02174835

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

June 23, 2014

Last Update Submit

April 23, 2026

Conditions

Healthy

Keywords

PharmacokineticsHealthy Volunteersdeuterated dextromethorphandeuterated dextromethorphan with quinidine

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of AVP-786

    7 days

Secondary Outcomes (1)

  • Incidence of adverse events (AEs) for AVP-786

    7 days

Study Arms (6)

Cohort A - Period 1

EXPERIMENTAL

Twice daily dosing orally for 7 days

Drug: AVP-786

Cohort A - Period 2

ACTIVE COMPARATOR

Twice daily dosing orally for 7 days

Drug: AVP-923

Cohort A - Period 3

EXPERIMENTAL

Twice daily dosing orally for 7 days

Drug: AVP-786

Cohort B - Period 1

EXPERIMENTAL

Twice daily dosing orally for 7 days

Drug: AVP-786

Cohort B - Period 2

ACTIVE COMPARATOR

Twice daily dosing orally for 7 days

Drug: AVP-923

Cohort B - Period 3

EXPERIMENTAL

Twice daily dosing orally for 7 days

Drug: AVP-786

Interventions

AVP-786DRUG
Cohort A - Period 1Cohort A - Period 3Cohort B - Period 1Cohort B - Period 3
AVP-923DRUG
Cohort A - Period 2Cohort B - Period 2

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

Location

Related Links

MeSH Terms

Interventions

dextromethorphan - quinidine combination

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2014

First Posted

June 26, 2014

Study Start

September 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

AU(1)