Healthy VolunteerPhase 1NCT02336347
A Phase 1 Study Comparing AVP-786 With AVP-923
A Phase 1 study testing AVP-786 and AVP-923 in people with Healthy Volunteer, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- AVP-786 and AVP-923
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2014to 1 Mar 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males or females
- 18 - 60 years of age
- BMI 18 - 32 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Dallas Clinical Research Unit
Dallas, Texas, 75247
About this study
Official title: A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, 2-way Crossover Study Comparing AVP-786 With AVP-923
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.
- Conditions
- Healthy Volunteer
- Being tested
- AVP-786, AVP-923
- Keywords
- Pharmacokinetics, Healthy Volunteers, deuterated dextromethorphan, deuterated dextromethorphan with quinidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVP-786Drug
Also called deuterated (d6)-dextropmethorphan/quindine sulfate
AVP-923Drug
Also called dextromethorphan/quinidine
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Period 1 | Experimental | Twice daily dosing of AVP-786 orally for 8 days Receives: Drug: AVP-786 |
| Group 1 - Period 2 | Active comparator | Twice daily dosing of AVP-923 orally for 8 days Receives: Drug: AVP-923 |
| Group 2 - Period 1 | Active comparator | Twice daily dosing of AVP-923 orally for 8 days Receives: Drug: AVP-923 |
| Group 2 - Period 2 | Experimental | Twice daily dosing of AVP-786 orally for 8 days Receives: Drug: AVP-786 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK of d6-DM in AVP-786 compared to DM in AVP-923
Measured: 8 days
Secondary outcomes (2)
PK of metabolites
Measured: 8 days
Safety and tolerability
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study start1 May 2014
- Primary completion1 Sep 2014
- Study completion1 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336347
- Sponsor's protocol ID
- 14-AVP-786-102
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2015
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, 2-way Crossover Study Comparing AVP-786 With AVP-923
- ClinicalTrials.gov ID
- NCT02336347
- Acronym / sponsor ID
- 14-AVP-786-102
- Conditions
- Healthy Volunteer
- Keywords
- Pharmacokinetics, Healthy Volunteers, deuterated dextromethorphan, deuterated dextromethorphan with quinidine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2014 (actual)
- Primary completion
- 1 Sep 2014 (actual)
- Study completion
- 1 Mar 2015 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Period 1 | Experimental | Drug: AVP-786Twice daily dosing of AVP-786 orally for 8 days |
| Group 1 - Period 2 | Active comparator | Drug: AVP-923Twice daily dosing of AVP-923 orally for 8 days |
| Group 2 - Period 1 | Active comparator | Drug: AVP-923Twice daily dosing of AVP-923 orally for 8 days |
| Group 2 - Period 2 | Experimental | Drug: AVP-786Twice daily dosing of AVP-786 orally for 8 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult males or females
- 18 - 60 years of age
- BMI 18 - 32 kg/m2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVP-786Also: deuterated (d6)-dextropmethorphan/quindine sulfate | Drug | Group 1 - Period 1, Group 2 - Period 2 |
| AVP-923Also: dextromethorphan/quinidine | Drug | Group 1 - Period 2, Group 2 - Period 1 |
Primary outcome
PK of d6-DM in AVP-786 compared to DM in AVP-923
Time frame: 8 days
2 secondary outcomes
PK of metabolites
Time frame: 8 days
Safety and tolerability
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Otsuka Clinical Trial WebsiteLink provided by the sponsor.
- Otsuka Clinical Trial TransparencyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVP-786 and AVP-923 in people with Healthy Volunteer, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK of d6-DM in AVP-786 compared to DM in AVP-923 (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.