Healthy Adult Male and Female VolunteersPhase 1NCT03381664
Study to Assess the Bioavailability, Pharmacokinetics, Safety, and Tolerability of AVP-923 in Healthy Adult Participants
A Phase 1 study testing AVP-923 in people with Healthy Adult Male and Female Volunteers, run by Avanir Pharmaceuticals at 1 site in United States.
Trial summary
This study will be conducted to evaluate the relative bioavailability, pharmacokinetics, safety, and tolerability of AVP-923 (dextromethorphan hydrobromide [DM] and quinidine sulfate [Q] capsules) when the contents of a capsule are administered in applesauce or via a nasogastric feeding tube, compared with… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male and Female Volunteers
- What is being tested?
- AVP-923
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2017to 30 Jan 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults, 18 to 65 years of age, inclusive
- Willing to sign informed consent form
- Cytochrome P450 2D6 genotype that confers extensive metabolizer profile (as per documented phenotype interpretation from local laboratory and approval from Avanir)
Who cannot join
- History or presence of significant pulmonary, hepatic, renal, hematologic, allergic, endocrine (including diabetes), immunologic, dermatologic, neurologic (including history or presence of seizures or convulsive disorders), psychiatric disease (including history of suicidal ideation or behavior) or any eating disorder deemed clinically significant by the investigator
- History or presence of significant cardiovascular disease, including complete heart block, QT interval corrected for heart rate (QTc) prolongation, and/or torsades de pointes
- History or presence of any gastrointestinal (GI) disease or condition that could compromise participant safety or affect the absorption of study drug, including GI ulcers, GI bleeding, esophageal or gastric varices, and dyspepsia requiring regular (i.e., more frequently than once a month) use of acid-reducing drugs
- Known hypersensitivity/intolerance to dextromethorphan or quinidine
- Participants whom the principal investigator or his delegate deems to be ineligible
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince & Associates Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1, Randomized, Single-Dose, 3-Way, Crossover Study to Compare the Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of AVP-923 (Dextromethorphan Hydrobromide and Quinidine Sulfate Capsules) Administered in Applesauce or Via a Nasogastric Feeding Tube With Administration of a Capsule in Healthy Adult Subjects
This study will be conducted to evaluate the relative bioavailability, pharmacokinetics, safety, and tolerability of AVP-923 (dextromethorphan hydrobromide [DM] and quinidine sulfate [Q] capsules) when the contents of a capsule are administered in applesauce or via a nasogastric feeding tube, compared with administration of a capsule in healthy, fasting, adult participants.
Read the detailed description
This is an open-label, single-center, randomized, single-dose, 3-treatment, 3-period, 6-sequence crossover study in healthy adult participants consisting of approximately 7 weeks of treatment. The study population will be limited to extensive metabolizers of cytochrome P450 (CYP) 2D6.
Approximately 18 participants will be randomly assigned to 1 of 6 sequences (ABC, ACB, BAC, BCA, CAB, CBA).
- Conditions
- Healthy Adult Male and Female Volunteers
- Being tested
- AVP-923
- Keywords
- bioavailability, pharmacokinetics, safety, tolerability, AVP-923, dextromethorphan, quinidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVP-923Drug
Also called Dextromethorphan Hydrobromide and Quinidine Sulfate
capsule
| Study group | Role | What they receive |
|---|---|---|
| AVP-923-20/10 capsule | Experimental | Participants will receive a single AVP-923-20/10 (dextromethorphan hydrobromide [DM] 20 milligram [mg]/quinidine sulfate [Q] 10 mg) capsule administered orally. Receives: Drug: AVP-923 |
| AVP-923-20/10 via applesauce | Experimental | Participants will receive the contents from a single AVP-923-20/10 capsule mixed and consumed in 1 tablespoon of applesauce. Receives: Drug: AVP-923 |
| AVP-923-20/10 via nasogastric feeding tube | Experimental | Participants will receive the contents from a single AVP-923-20/10 capsule solubilized in feeding solution and administered through a nasogastric feeding tube. Receives: Drug: AVP-923 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean area under the concentration time curve (AUC) from time 0 to time of last measurable concentration (AUC0-t) for the analytes dextromethorphan (DM), dextrorphan (DX), 3-methoxymorphinan (3-MM), and quinidine (Q)
Measured: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)
Mean AUC from time 0 to infinity (AUC0-inf) for the analytes DM, DX, 3-MM, and Q
Measured: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)
Mean maximum plasma concentration (Cmax) for the analytes DM, DX, 3-MM, and Q
Measured: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)
Mean time to maximum plasma concentration (Tmax) for the analytes DM, DX, 3-MM, and Q
Measured: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)
Mean apparent terminal elimination half-life (t1/2) for the analytes DM, DX, 3-MM, and Q
Measured: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)
Mean apparent elimination rate constant (kel) for the analytes DM, DX, 3-MM, and Q
Measured: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)
Secondary outcomes (6)
Number of participants with any adverse event
Measured: 3 weeks
Number of participants with any clinically significant clinical laboratory evaluation
Clinical significance will be determined by the Investigator.
Measured: 3 weeks
Number of participants with any clinically significant physical examination evaluation
Clinical significance will be determined by the Investigator.
Measured: 3 weeks
Number of participants with any clinically significant electrocardiogram evaluation
Clinical significance will be determined by the Investigator.
Measured: 3 weeks
Number of participants with any clinically significant vital sign value
Clinical significance will be determined by the Investigator.
Measured: 3 weeks
Number of participants with the indicated score on the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS will be used to prospectively assess suicidal ideation (intensity rated from 1 [low severity] to 5 [high severity]) and behavior throughout the study.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start28 Nov 2017
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Male and Female VolunteersStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avanir Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381664
- Sponsor's protocol ID
- 17-AVR-135
- Status last verified
- Feb 2018
- First submitted
- 18 Dec 2017
- Last updated
- 23 Feb 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Single-Dose, 3-Way, Crossover Study to Compare the Relative Bioavailability, Pharmacokinetics, Safety and Tolerability of AVP-923 (Dextromethorphan Hydrobromide and Quinidine Sulfate Capsules) Administered in Applesauce or Via a Nasogastric Feeding Tube With Administration of a Capsule in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03381664
- Acronym / sponsor ID
- 17-AVR-135
- Conditions
- Healthy Adult Male and Female Volunteers
- Keywords
- bioavailability, pharmacokinetics, safety, tolerability, AVP-923, dextromethorphan, quinidine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Avanir PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 22 Dec 2017 (actual)
- 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.
This study will be conducted to evaluate the relative bioavailability, pharmacokinetics, safety, and tolerability of AVP-923 (dextromethorphan hydrobromide [DM] and quinidine sulfate [Q] capsules) when the contents of a capsule are administered in applesauce or via a nasogastric feeding tube, compared with administration of a capsule in healthy, fasting, adult participants.
Detailed description
This is an open-label, single-center, randomized, single-dose, 3-treatment, 3-period, 6-sequence crossover study in healthy adult participants consisting of approximately 7 weeks of treatment. The study population will be limited to extensive metabolizers of cytochrome P450 (CYP) 2D6.
Approximately 18 participants will be randomly assigned to 1 of 6 sequences (ABC, ACB, BAC, BCA, CAB, CBA).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AVP-923-20/10 capsule | Experimental | Drug: AVP-923Participants will receive a single AVP-923-20/10 (dextromethorphan hydrobromide [DM] 20 milligram [mg]/quinidine sulfate [Q] 10 mg) capsule administered orally. |
| AVP-923-20/10 via applesauce | Experimental | Drug: AVP-923Participants will receive the contents from a single AVP-923-20/10 capsule mixed and consumed in 1 tablespoon of applesauce. |
| AVP-923-20/10 via nasogastric feeding tube | Experimental | Drug: AVP-923Participants will receive the contents from a single AVP-923-20/10 capsule solubilized in feeding solution and administered through a nasogastric feeding tube. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults, 18 to 65 years of age, inclusive
- Willing to sign informed consent form
- Cytochrome P450 2D6 genotype that confers extensive metabolizer profile (as per documented phenotype interpretation from local laboratory and approval from Avanir)
Key exclusion criteria (5 listed)
- History or presence of significant pulmonary, hepatic, renal, hematologic, allergic, endocrine (including diabetes), immunologic, dermatologic, neurologic (including history or presence of seizures or convulsive disorders), psychiatric disease (including history of suicidal ideation or behavior) or any eating disorder deemed clinically significant by the investigator
- History or presence of significant cardiovascular disease, including complete heart block, QT interval corrected for heart rate (QTc) prolongation, and/or torsades de pointes
- History or presence of any gastrointestinal (GI) disease or condition that could compromise participant safety or affect the absorption of study drug, including GI ulcers, GI bleeding, esophageal or gastric varices, and dyspepsia requiring regular (i.e., more frequently than once a month) use of acid-reducing drugs
- Known hypersensitivity/intolerance to dextromethorphan or quinidine
- Participants whom the principal investigator or his delegate deems to be ineligible
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-923Also: Dextromethorphan Hydrobromide and Quinidine Sulfatecapsule | Drug | AVP-923-20/10 capsule, AVP-923-20/10 via applesauce, AVP-923-20/10 via nasogastric feeding tube |
Primary outcome
Mean area under the concentration time curve (AUC) from time 0 to time of last measurable concentration (AUC0-t) for the analytes dextromethorphan (DM), dextrorphan (DX), 3-methoxymorphinan (3-MM), and quinidine (Q)
Time frame: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)
Mean AUC from time 0 to infinity (AUC0-inf) for the analytes DM, DX, 3-MM, and Q
Time frame: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)
Mean maximum plasma concentration (Cmax) for the analytes DM, DX, 3-MM, and Q
Time frame: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)
Mean time to maximum plasma concentration (Tmax) for the analytes DM, DX, 3-MM, and Q
Time frame: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)
Mean apparent terminal elimination half-life (t1/2) for the analytes DM, DX, 3-MM, and Q
Time frame: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)
Mean apparent elimination rate constant (kel) for the analytes DM, DX, 3-MM, and Q
Time frame: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)
6 secondary outcomes
Number of participants with any adverse event
Time frame: 3 weeks
Number of participants with any clinically significant clinical laboratory evaluation
Time frame: 3 weeks
Number of participants with any clinically significant physical examination evaluation
Time frame: 3 weeks
Number of participants with any clinically significant electrocardiogram evaluation
Time frame: 3 weeks
Number of participants with any clinically significant vital sign value
Time frame: 3 weeks
Number of participants with the indicated score on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 3 weeks
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 23 Feb 2018.
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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 in people with Healthy Adult Male and Female Volunteers, run by Avanir Pharmaceuticals 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 5 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 23 Feb 2018. 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?
Mean area under the concentration time curve (AUC) from time 0 to time of last measurable concentration (AUC0-t) for the analytes dextromethorphan (DM), dextrorphan (DX), 3-methoxymorphinan (3-MM), and quinidine (Q) (time frame: pre-dose (within 30 minutes prior to dosing) and post-dose (up to 48 hours after drug administration)). The study lists 6 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 23 Feb 2018.