HealthyPhase 1DDINCT02402595
Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts
A Phase 1 study testing AVP-923, AVP-786 and Itraconazole in people with Healthy, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor, itraconazole, on the steady-state PK of AVP-923 and AVP-786. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AVP-923, AVP-786 and Itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2015to 1 Jul 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males and females, 18 to 55 years of age
- Body Mass Index (BMI) ≥19 and ≤30 kg/m2 (for both males and females)
Who cannot join
- History or presence of significant disease
- History of substance abuse or dependence (except caffeine), or treatment for substance use disorder(s) within the year prior to screening or within 6 months for nicotine including e-cigarettes
- Use of any tobacco-containing or nicotine-containing products within 6 months prior to the first dose
- 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
Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, Drug Interaction Study Between AVP-923 and Itraconazole, and Between AVP-786 and Itraconazole in Healthy Adult Subjects
The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor, itraconazole, on the steady-state PK of AVP-923 and AVP-786.
Read the detailed description
A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.
- Conditions
- Healthy
- Being tested
- AVP-923, AVP-786, Itraconazole
- Keywords
- Drug-drug interaction, Healthy Volunteers, Pharmacokinetics, deuterated dextromethorphan, dextromethorphan, dextromethorphan with quinidine, deuterated dextromethorphan with quinidine, itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVP-923Drug
AVP-786Drug
ItraconazoleDrug
Also called Sporanex
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 - Period 1 | Experimental | AVP-923 and placebo matching AVP-786- BID Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 Receives: Drug: AVP-923; Drug: Itraconazole |
| Sequence 1 - Period 2 (after 3-week washout) | Experimental | AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 Receives: Drug: AVP-786; Drug: Itraconazole |
| Sequence 2 - Period 1 | Experimental | AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 Receives: Drug: AVP-786; Drug: Itraconazole |
| Sequence 2 - Period 2 (after 3-week washout) | Experimental | AVP-923 and placebo matching AVP-786- BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 Receives: Drug: AVP-923; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma concentration of AVP-923 after dosing in combination with itraconazole
Measured: 16 Days
Change in plasma concentration of AVP-786 after dosing in combination with itraconazole
Measured: 16 Days
Secondary outcomes (2)
Incidence of adverse events (AEs) for AVP-923 and itraconazole
Measured: 16 Days
Incidence of adverse events (AEs) for AVP-786 and itraconazole
Measured: 16 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study start1 Mar 2015
- Primary completion1 Jul 2015
- Study completion1 Jul 2015
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402595
- Sponsor's protocol ID
- 15-AVP-786-103
- Acronym
- DDI
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 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, Drug Interaction Study Between AVP-923 and Itraconazole, and Between AVP-786 and Itraconazole in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02402595
- Acronym / sponsor ID
- DDI / 15-AVP-786-103
- Conditions
- Healthy
- Keywords
- Drug-drug interaction, Healthy Volunteers, Pharmacokinetics, deuterated dextromethorphan, dextromethorphan, dextromethorphan with quinidine, deuterated dextromethorphan with quinidine, itraconazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 30 Mar 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.
The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor, itraconazole, on the steady-state PK of AVP-923 and AVP-786.
Detailed description
A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 - Period 1 | Experimental | Drug: AVP-923, Drug: ItraconazoleAVP-923 and placebo matching AVP-786- BID Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 |
| Sequence 1 - Period 2 (after 3-week washout) | Experimental | Drug: AVP-786, Drug: ItraconazoleAVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 |
| Sequence 2 - Period 1 | Experimental | Drug: AVP-786, Drug: ItraconazoleAVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 |
| Sequence 2 - Period 2 (after 3-week washout) | Experimental | Drug: AVP-923, Drug: ItraconazoleAVP-923 and placebo matching AVP-786- BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult males and females, 18 to 55 years of age
- Body Mass Index (BMI) ≥19 and ≤30 kg/m2 (for both males and females)
Key exclusion criteria (4 listed)
- History or presence of significant disease
- History of substance abuse or dependence (except caffeine), or treatment for substance use disorder(s) within the year prior to screening or within 6 months for nicotine including e-cigarettes
- Use of any tobacco-containing or nicotine-containing products within 6 months prior to the first dose
- 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-923 | Drug | Sequence 1 - Period 1, Sequence 2 - Period 2 (after 3-week washout) |
| AVP-786 | Drug | Sequence 1 - Period 2 (after 3-week washout), Sequence 2 - Period 1 |
| ItraconazoleAlso: Sporanex | Drug | Sequence 1 - Period 1, Sequence 1 - Period 2 (after 3-week washout), Sequence 2 - Period 1, Sequence 2 - Period 2 (after 3-week washout) |
Primary outcome
Change in plasma concentration of AVP-923 after dosing in combination with itraconazole
Time frame: 16 Days
Change in plasma concentration of AVP-786 after dosing in combination with itraconazole
Time frame: 16 Days
2 secondary outcomes
Incidence of adverse events (AEs) for AVP-923 and itraconazole
Time frame: 16 Days
Incidence of adverse events (AEs) for AVP-786 and itraconazole
Time frame: 16 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-923, AVP-786 and Itraconazole in people with Healthy, 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 2 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?
Change in plasma concentration of AVP-923 after dosing in combination with itraconazole (time frame: 16 Days). The study lists 2 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 28 Apr 2026.