NCT01787747

Brief Summary

To assess the single- and multiple-dose pharmacokinetic (PK), safety and tolerability of AVP-786 in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Oct 2012

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

October 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

February 6, 2013

Last Update Submit

April 23, 2026

Conditions

Healthy

Keywords

PharmacokineticsHealthy Volunteersdextromethorphan with quinidinedeuterated dextromethorphan

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of parent and metabolites

    8 Days

Secondary Outcomes (1)

  • Safety and tolerability

    8 days

Study Arms (5)

Cohorts A and C

EXPERIMENTAL

Single dose (D1) followed by twice daily dosing for 7 days

Drug: AVP-786 Dose 1Drug: AVP-923

Cohorts B and D

EXPERIMENTAL

Single dose (D1) followed by twice daily dosing for 7 days

Drug: AVP-786 Dose 2Drug: AVP-923

Cohorts E and F

EXPERIMENTAL

Single dose (D1) followed by twice daily dosing for 7 days

Drug: AVP-786 Dose 1/Q Dose 1Drug: AVP-923

Cohorts G and I

EXPERIMENTAL

Single dose (D1) followed by twice daily dosing for 7 days

Drug: AVP-786 Dose 1/Q Dose 2Drug: AVP-923

Cohorts H and J

EXPERIMENTAL

Single dose (D1) followed by twice daily dosing for 7 days

Drug: AVP-786 Dose 2/Q Dose 2Drug: AVP-923

Interventions

AVP-786 Dose 1DRUG
Cohorts A and C
AVP-786 Dose 2DRUG
Cohorts B and D
AVP-786 Dose 1/Q Dose 1DRUG
Cohorts E and F
AVP-786 Dose 1/Q Dose 2DRUG
Cohorts G and I
AVP-786 Dose 2/Q Dose 2DRUG
Cohorts H and J
AVP-923DRUG
Cohorts A and CCohorts B and DCohorts E and FCohorts G and ICohorts H and J

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 and/or alcohol abuse within the past 3 years
  • Use of tobacco-containing or nicotine-contining products within 6 months
  • Use of any prescription of over-the-counter (OTC) medication 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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 11, 2013

Study Start

October 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

AU(1)