Drug-drug InteractionPhase 1NCT02174822
A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects
A Phase 1 study testing AVP-786, Paroxetine and Duloxetine in people with Drug-drug Interaction, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in Australia.
Trial summary
To assess steady state pharmacokinetics (PK), safety and tolerability between AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) and paroxetine and between AVP-786 and duloxetine. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-drug Interaction
- What is being tested?
- AVP-786, Paroxetine and Duloxetine
- 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
- Jan 2014to Apr 2014
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males and females
- 18 - 50 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, Open-label, Sequential Drug Interaction Study Between AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [DM]/Quinidine Sulfate [Q]) and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects
To assess steady state pharmacokinetics (PK), safety and tolerability between AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) and paroxetine and between AVP-786 and duloxetine.
- Conditions
- Drug-drug Interaction
- Being tested
- AVP-786, Paroxetine, Duloxetine
- Keywords
- Drug-drug interaction, 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
ParoxetineDrug
DuloxetineDrug
| Study group | Role | What they receive |
|---|---|---|
| Paroxetine + AVP-786 | Experimental | Paroxetine once daily orally Days 1-20. AVP-786 twice daily orally for Days 13 - 20. Receives: Drug: AVP-786; Drug: Paroxetine |
| AVP-786 + paroxetine | Experimental | AVP-786 twice daily orally Days 1-20. Paroxetine once daily orally for Days 9 - 20 Receives: Drug: AVP-786; Drug: Paroxetine |
| Duloxetine + AVP-786 | Experimental | Duloxetine twice daily orally Days 1 - 13. AVP-786 twice daily orally Days 6 - 13. Receives: Drug: AVP-786; Drug: Duloxetine |
| AVP-786 + duloxetine | Experimental | AVP-786 twice daily orally Days 1 - 13. Duloxetine twice daily Days 9 - 13. Receives: Drug: AVP-786; Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma concentrations of paroxetine after combined dosing with AVP-786 paroxetine in healthy subjects
Measured: 20 days
Change in plasma concentration of AVP-786 (parent and metabolites) after dosing in combination with paroxetine.
Measured: 20 days
Change in plasma concentration of duloxetine after combined dosing with AVP-786
Measured: 13 days
Change in plasma concentration of AVP-786 after combined dosing with duloxetine.
Measured: 13 days
Secondary outcomes (2)
Incidence of adverse events (AEs) for AVP-786 and paroxetine
Measured: 20 days
Incidence of adverse events (AEs) for AVP-786 and duloxetine
Measured: 13 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 startJan 2014
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-drug InteractionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Lickliter, MBBS PhD FRACP, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174822
- Sponsor's protocol ID
- 14-AVP-786-101
- Status last verified
- Jun 2014
- First submitted
- 23 Jun 2014
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Open-label, Sequential Drug Interaction Study Between AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [DM]/Quinidine Sulfate [Q]) and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02174822
- Acronym / sponsor ID
- 14-AVP-786-101
- Conditions
- Drug-drug Interaction
- Keywords
- Drug-drug interaction, 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
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (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 steady state pharmacokinetics (PK), safety and tolerability between AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) and paroxetine and between AVP-786 and duloxetine.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Paroxetine + AVP-786 | Experimental | Drug: AVP-786, Drug: ParoxetineParoxetine once daily orally Days 1-20. AVP-786 twice daily orally for Days 13 - 20. |
| AVP-786 + paroxetine | Experimental | Drug: AVP-786, Drug: ParoxetineAVP-786 twice daily orally Days 1-20. Paroxetine once daily orally for Days 9 - 20 |
| Duloxetine + AVP-786 | Experimental | Drug: AVP-786, Drug: DuloxetineDuloxetine twice daily orally Days 1 - 13. AVP-786 twice daily orally Days 6 - 13. |
| AVP-786 + duloxetine | Experimental | Drug: AVP-786, Drug: DuloxetineAVP-786 twice daily orally Days 1 - 13. Duloxetine twice daily Days 9 - 13. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult males and females
- 18 - 50 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 | AVP-786 + duloxetine, AVP-786 + paroxetine, Duloxetine + AVP-786, Paroxetine + AVP-786 |
| Paroxetine | Drug | AVP-786 + paroxetine, Paroxetine + AVP-786 |
| Duloxetine | Drug | AVP-786 + duloxetine, Duloxetine + AVP-786 |
Primary outcome
Change in plasma concentrations of paroxetine after combined dosing with AVP-786 paroxetine in healthy subjects
Time frame: 20 days
Change in plasma concentration of AVP-786 (parent and metabolites) after dosing in combination with paroxetine.
Time frame: 20 days
Change in plasma concentration of duloxetine after combined dosing with AVP-786
Time frame: 13 days
Change in plasma concentration of AVP-786 after combined dosing with duloxetine.
Time frame: 13 days
2 secondary outcomes
Incidence of adverse events (AEs) for AVP-786 and paroxetine
Time frame: 20 days
Incidence of adverse events (AEs) for AVP-786 and duloxetine
Time frame: 13 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 18 Feb 2022.
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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.
Jason Lickliter, MBBS PhD FRACP principal investigator
Nucleus Network
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, Paroxetine and Duloxetine in people with Drug-drug Interaction, 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 18 Feb 2022. 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?
Change in plasma concentrations of paroxetine after combined dosing with AVP-786 paroxetine in healthy subjects (time frame: 20 days). The study lists 4 primary outcomes in all. 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 18 Feb 2022.