HealthyPhase 1NCT02174835
A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers
A Phase 1 study testing AVP-786 and AVP-923 in people with Healthy, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 56 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Sep 2013to 1 Nov 2013
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males
- 18 - 45 years of age
- BMI 18 - 30 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy volunteers.
- Conditions
- Healthy
- 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
AVP-923Drug
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Period 1 | Experimental | Twice daily dosing orally for 7 days Receives: Drug: AVP-786 |
| Cohort A - Period 2 | Active comparator | Twice daily dosing orally for 7 days Receives: Drug: AVP-923 |
| Cohort A - Period 3 | Experimental | Twice daily dosing orally for 7 days Receives: Drug: AVP-786 |
| Cohort B - Period 1 | Experimental | Twice daily dosing orally for 7 days Receives: Drug: AVP-786 |
| Cohort B - Period 2 | Active comparator | Twice daily dosing orally for 7 days Receives: Drug: AVP-923 |
| Cohort B - Period 3 | Experimental | Twice daily dosing orally for 7 days Receives: Drug: AVP-786 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of AVP-786
Measured: 7 days
Secondary outcomes (1)
Incidence of adverse events (AEs) for AVP-786
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study start1 Sep 2013
- Primary completion1 Nov 2013
- Study completion1 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174835
- Sponsor's protocol ID
- 13-AVR-134
- Status last verified
- Apr 2026
- First submitted
- 23 Jun 2014
- 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, Open-label Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide/Quinidine Sulfate) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02174835
- Acronym / sponsor ID
- 13-AVR-134
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Healthy Volunteers, deuterated dextromethorphan, deuterated dextromethorphan with quinidine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Nov 2013 (actual)
- Study completion
- 1 Nov 2013 (actual)
- First posted
- 26 Jun 2014 (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 assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Period 1 | Experimental | Drug: AVP-786Twice daily dosing orally for 7 days |
| Cohort A - Period 2 | Active comparator | Drug: AVP-923Twice daily dosing orally for 7 days |
| Cohort A - Period 3 | Experimental | Drug: AVP-786Twice daily dosing orally for 7 days |
| Cohort B - Period 1 | Experimental | Drug: AVP-786Twice daily dosing orally for 7 days |
| Cohort B - Period 2 | Active comparator | Drug: AVP-923Twice daily dosing orally for 7 days |
| Cohort B - Period 3 | Experimental | Drug: AVP-786Twice daily dosing orally for 7 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult males
- 18 - 45 years of age
- BMI 18 - 30 kg/m2
Key exclusion criteria (4 listed)
- 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
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-786 | Drug | Cohort A - Period 1, Cohort A - Period 3, Cohort B - Period 1, Cohort B - Period 3 |
| AVP-923 | Drug | Cohort A - Period 2, Cohort B - Period 2 |
Primary outcome
Plasma concentrations of AVP-786
Time frame: 7 days
1 secondary outcome
Incidence of adverse events (AEs) for AVP-786
Time frame: 7 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, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in Australia.
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 Australia. 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?
Plasma concentrations of AVP-786 (time frame: 7 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.