A Phase 1 Study Comparing AVP-786 With AVP-923 | NCT02336347

Studies
A Phase 1 Study Comparing AVP-786 With AVP-923

NCT02336347

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Status

Completed

Last Update Posted

Apr 28, 2026Actual

Enrollment

62Actual

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

AVP-786
AVP-923

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2014Actual

Primary Completion Date

Sep 1, 2014Actual

Completion Date

Mar 1, 2015Actual

First Submitted Date

Jan 8, 2015

First Submission Date that Met QC Criteria

Jan 8, 2015

First Posted Date

Jan 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2026

Last Update Posted Date

Apr 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To compare pharmacokinetics (PK) of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) to AVP-923 (dextromethorphan hydrobromide [DM]/Q) at steady state.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1 - Period 1	Experimental	Twice daily dosing of AVP-786 orally for 8 days	Drug: AVP-786
Group 1 - Period 2	Active Comparator	Twice daily dosing of AVP-923 orally for 8 days	Drug: AVP-923
Group 2 - Period 1	Active Comparator	Twice daily dosing of AVP-923 orally for 8 days	Drug: AVP-923
Group 2 - Period 2	Experimental	Twice daily dosing of AVP-786 orally for 8 days	Drug: AVP-786

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AVP-786	Drug		Group 1 - Period 1 Group 2 - Period 2	deuterated (d6)-dextropmethorphan/quindine sulfate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PK of d6-DM in AVP-786 compared to DM in AVP-923		8 days

Secondary Outcomes

Measure	Description	Time Frame
PK of metabolites		8 days
Safety and tolerability		8 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult males or females
18 - 60 years of age
BMI 18 - 32 kg/m2

Exclusion Criteria:

History or presence of significant disease
History of substance abuse and/or alcohol abuse with the past 2 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Covance Dallas Clinical Research Unit		Dallas	Texas	75247	United States

References Module

Citations

Not provided

Label	URL
Otsuka Clinical Trial Website	View source
Otsuka Clinical Trial Transparency	View source