HealthyPhase 1NCT06585163
Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension
A Phase 1 study testing Hydrocodone Bitartrate and Hydrocodone Bitartrate + Doxapram Hydrochloride in people with Healthy and PK Drug-drug Interaction Study, run by Quivive Pharma, Inc. at 1 site in United States.
Trial summary
This study has been designed to assess the safety, tolerability, and pharmacokinetics of a therapeutic dose of hydrocodone bitartrate with and without an oral dose of doxapram hydrochloride in healthy volunteers who are naltrexone-blocked. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, PK Drug-drug Interaction Study
- What is being tested?
- Hydrocodone Bitartrate and Hydrocodone Bitartrate + Doxapram Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 26 Nov 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female aged 18-55 years, inclusive, on the day of screening.
- Willing to abstain from alcohol and strenuous physical activity (i.e., strenuous, or unaccustomed weightlifting, running, bicycling, etc.) from 48 hours prior to study treatment administration until discharge from the clinical unit and prior to each outpatient visit.
- Have normal laboratory values, as defined per protocol, at screening.
- Absence of cardiac arrythmias, as well as corrected QT interval (QTc) < 450 ms in males and QTc < 460 ms in females based on 12-lead ECG findings at screening.
- Body weight ≥50 kg and body mass index (BMI) within the range of 19-32 kg/m2 (inclusive).
- Has never used opioids for non-therapeutic purposes (i.e., for recreational effects). Subjects with a history of valid medical use under prescription must have not used an opioid for at least three (3) months prior to Day 1.
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- Women of childbearing potential (WOCBP), as defined in Section 10.4, must have a negative serum pregnancy test within one (1) week AND a negative urine pregnancy test on Day 2, prior to the start of study treatment; Must not be breastfeeding, lactating, or planning a pregnancy during the study and for at least 32 days (5 half-lives plus 30-days) after the last dose of study intervention
- Postmenopausal females must have a documented serum follicle-stimulating hormone (FSH) level >40 mIU/mL (milli international units per milliliter) at screening to confirm menopause.
- Male participants with female sexual partners who are WOCBP must agree to remain abstinent (complete avoidance of heterosexual intercourse) or use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, during the treatment period and for at least 92 days (5 half-lives + 90-day spermatogenesis cycle) after the last dose of study intervention; must not donate sperm for at least 92 days (5 half-lives + 90-day spermatogenesis cycle) after the last dose of study intervention.
Who cannot join
- Female subject who is pregnant or lactating.
- Have any vital sign abnormalities as described in the protocol.
- Recreational opioid user who has used opioids for non-therapeutic purposes (i.e., for psychoactive effects) or who is physically dependent on any illicit or prescription opioid, and/or currently participating in a treatment program for individuals with opioid dependence.
- Known allergy or history of significant adverse reaction to hydrocodone or its metabolites, other opioids, or related compounds, doxapram hydrochloride, naltrexone, naloxone, or to any of the excipients in QEV-817.
- History of or currently has hypoventilation syndrome or sleep apnea and is on non-invasive ventilation (e.g., CPAP).
- Clinically meaningful infection/injury/illness within one month prior to screening.
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- Active malignancy (excluding squamous or basal cell carcinoma of the skin) within 5 years of screening.
- Subjects with hepatic impairment as defined by screening alanine transaminase (ALT), aspartate transaminase (AST) or total bilirubin >3× upper limit of normal (ULN).
- Subjects with renal impairment as defined by screening estimated creatinine clearance/eGFR (estimated glomerular filtration rate) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation is <60 mL/min/1.73 m2.
- Donation of blood (>450 mL) or significant blood loss within 56 days.
- Current (or recent history of) psychiatric illness or mental impairment.
- Clinically meaningful current (or history of) unstable chronic disease; medical abnormality; or significant cardiovascular (including significant cardiovascular impairment, uncompensated heart failure, severe coronary artery disease, severe hypertension), endocrine, gastrointestinal, neurological disorder (including cognitive disorders); or metabolic disease.
- Currently active (or history of) epilepsy, seizure disorder, serious head injury, cerebral vascular accident, or cerebral edema.
- Current treatment with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, sympathomimetic drugs, neuromuscular blocking agents, narcotics, antihistamines, antipsychotics, antianxiety agents, or other central nervous system (CNS) depressants.
- Use of any prescription or over the counter (OTC) medications including food supplements and herbal medications (e.g., St. John's wort), with the exception of contraceptive medications or a daily multivitamin, within fourteen (14) days prior to study treatment administration. Use of CYP3A4 inhibitors or inducers is prohibited within 28 days prior to the first treatment and throughout the treatment and follow-up periods.
- A positive urine drug, cotinine, or alcohol test at screening, excluding tetrahydro-cannabinol (THC) or cannabinoid metabolites.
- Smokers or use of tobacco-containing products within 6 weeks of study drug administration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services, Inc.
Secaucus, New Jersey, 07094
About this study
Official title: A Phase 1, Randomized, Open Label, Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QEV-817 Oral Suspension in Healthy Volunteers
This study has been designed to assess the safety, tolerability, and pharmacokinetics of a therapeutic dose of hydrocodone bitartrate with and without an oral dose of doxapram hydrochloride in healthy volunteers who are naltrexone-blocked.
Read the detailed description
This is a Phase 1, single-center, randomized, open label, crossover study that will be conducted in male and female healthy volunteers. The study will be conducted at a single site in the US. The study consists of a 28-day Screening Period, a four-day treatment period, and a one-day safety follow-up period.
The study will be conducted in eight (8) healthy male and female subjects. Up to an additional five (5) subjects may be enrolled as alternates to replace dropouts. Subjects will be randomized (1:1) to one of two crossover treatment sequences.
Subjects will receive either a fixed therapeutic dose of oral hydrocodone bitartrate alone or in combination with a fixed dose of oral doxapram hydrochloride. Prior to treatment, all subjects will receive naltrexone (opioid antagonist) to block opioid effects (i.e., naltrexone block).
Safety will be evaluated by monitoring the nature, severity, and incidence of adverse events (AEs); and changes from baseline in physical examination, vital signs, 12-lead electrocardiogram (ECG) assessment, pulse oximetry, and clinical laboratory tests.
Pharmacokinetics of both drugs and their primary metabolites will be assessed in plasma samples collected through 24 hours post-dose from all subjects.
- Conditions
- Healthy, PK Drug-drug Interaction Study
- Being tested
- Hydrocodone Bitartrate, Hydrocodone Bitartrate + Doxapram Hydrochloride
- Keywords
- pharmacokinetics, hydrocodone, doxapram, oral, safety, tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocodone BitartrateDrug
Also called NDC 51634-0014
Hydrocodone bitartrate oral suspension
Hydrocodone Bitartrate + Doxapram HydrochlorideDrug
Also called NDC 10920-601, NDC 51634-0014
Doxapram hydrocholoride oral suspension
| Study group | Role | What they receive |
|---|---|---|
| Sequence A - Hydrocodone alone followed by combined (hydrocodone + doxapram) | Experimental | Subjects randomized to Sequence A will first receive a single oral administration of hydrocodone bitartrate alone on Study Day-2 and then receive a combination of hydrocodone bitartrate and doxapram hydrocholoride on study Day-4 (after a 48 hour wash-out). Receives: Drug: Hydrocodone Bitartrate; Drug: Hydrocodone Bitartrate + Doxapram Hydrochloride |
| Sequence B - Combined (hydrocodone + doxapram) followed by hydrocodone alone | Experimental | Subjects randomized to Sequence B will first receive a single combined administration of hydrocodone bitartrate and doxapram hydrocholoride on Study Day-2 and then receive hydrocodone alone on study Day-4 (after a 48 hour wash-out). Receives: Drug: Hydrocodone Bitartrate; Drug: Hydrocodone Bitartrate + Doxapram Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs
Number of participants with clinically meaningful changes from baseline in physical examination, vital signs, 12-lead ECG assessment and/or pulse oximetry
Measured: Day 1 to Day 5
Secondary outcomes (3)
Plasma PK Parameters (Cmax)
Maximal plasma concentrations for hydrocodone
Measured: Day 2 and Day 4
Plasma PK Parameter (AUC0-24h)
Plasma area under the curve from 0 to 24h for hydrocodone
Measured: Day 2 and Day 4
Plasma PK Parameter (Tmax)
Time to maximal plasma concentrations for hydrocodone
Measured: Day 2 and Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start18 Aug 2025
- Primary completion29 Aug 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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
- Model description
- Subjects will be randomized to receive A) hydrocodone and B) hydrocodone + doxapram in one of two possible sequences (ie. A followed by B or B followed by A).
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quivive Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Frank Lee, MD, Principal investigator, Frontage Clinical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585163
- Sponsor's protocol ID
- QEV-817-101
- Status last verified
- Jul 2026
- First submitted
- 1 Sep 2024
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results to be reported, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open Label, Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QEV-817 Oral Suspension in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06585163
- Acronym / sponsor ID
- QEV-817-101
- Conditions
- Healthy, PK Drug-drug Interaction Study
- Keywords
- pharmacokinetics, hydrocodone, doxapram, oral, safety, tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Quivive Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 5 Sep 2024 (actual)
- Results
- Posted 5 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has been designed to assess the safety, tolerability, and pharmacokinetics of a therapeutic dose of hydrocodone bitartrate with and without an oral dose of doxapram hydrochloride in healthy volunteers who are naltrexone-blocked.
Detailed description
This is a Phase 1, single-center, randomized, open label, crossover study that will be conducted in male and female healthy volunteers. The study will be conducted at a single site in the US. The study consists of a 28-day Screening Period, a four-day treatment period, and a one-day safety follow-up period.
The study will be conducted in eight (8) healthy male and female subjects. Up to an additional five (5) subjects may be enrolled as alternates to replace dropouts. Subjects will be randomized (1:1) to one of two crossover treatment sequences.
Subjects will receive either a fixed therapeutic dose of oral hydrocodone bitartrate alone or in combination with a fixed dose of oral doxapram hydrochloride. Prior to treatment, all subjects will receive naltrexone (opioid antagonist) to block opioid effects (i.e., naltrexone block).
Safety will be evaluated by monitoring the nature, severity, and incidence of adverse events (AEs); and changes from baseline in physical examination, vital signs, 12-lead electrocardiogram (ECG) assessment, pulse oximetry, and clinical laboratory tests.
Pharmacokinetics of both drugs and their primary metabolites will be assessed in plasma samples collected through 24 hours post-dose from all subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized to receive A) hydrocodone and B) hydrocodone + doxapram in one of two possible sequences (ie. A followed by B or B followed by A).
| Arm | Type | Receives |
|---|---|---|
| Sequence A - Hydrocodone alone followed by combined (hydrocodone + doxapram) | Experimental | Drug: Hydrocodone Bitartrate, Drug: Hydrocodone Bitartrate + Doxapram HydrochlorideSubjects randomized to Sequence A will first receive a single oral administration of hydrocodone bitartrate alone on Study Day-2 and then receive a combination of hydrocodone bitartrate and doxapram hydrocholoride on study Day-4 (after a 48 hour wash-out). |
| Sequence B - Combined (hydrocodone + doxapram) followed by hydrocodone alone | Experimental | Drug: Hydrocodone Bitartrate, Drug: Hydrocodone Bitartrate + Doxapram HydrochlorideSubjects randomized to Sequence B will first receive a single combined administration of hydrocodone bitartrate and doxapram hydrocholoride on Study Day-2 and then receive hydrocodone alone on study Day-4 (after a 48 hour wash-out). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female aged 18-55 years, inclusive, on the day of screening.
- Willing to abstain from alcohol and strenuous physical activity (i.e., strenuous, or unaccustomed weightlifting, running, bicycling, etc.) from 48 hours prior to study treatment administration until discharge from the clinical unit and prior to each outpatient visit.
- Have normal laboratory values, as defined per protocol, at screening.
- Absence of cardiac arrythmias, as well as corrected QT interval (QTc) < 450 ms in males and QTc < 460 ms in females based on 12-lead ECG findings at screening.
- Body weight ≥50 kg and body mass index (BMI) within the range of 19-32 kg/m2 (inclusive).
Key exclusion criteria (17 listed)
- Female subject who is pregnant or lactating.
- Have any vital sign abnormalities as described in the protocol.
- Recreational opioid user who has used opioids for non-therapeutic purposes (i.e., for psychoactive effects) or who is physically dependent on any illicit or prescription opioid, and/or currently participating in a treatment program for individuals with opioid dependence.
- Known allergy or history of significant adverse reaction to hydrocodone or its metabolites, other opioids, or related compounds, doxapram hydrochloride, naltrexone, naloxone, or to any of the excipients in QEV-817.
- History of or currently has hypoventilation syndrome or sleep apnea and is on non-invasive ventilation (e.g., CPAP).
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 |
|---|---|---|
| Hydrocodone BitartrateAlso: NDC 51634-0014Hydrocodone bitartrate oral suspension | Drug | Sequence A - Hydrocodone alone followed by combined (hydrocodone + doxapram), Sequence B - Combined (hydrocodone + doxapram) followed by hydrocodone alone |
| Hydrocodone Bitartrate + Doxapram HydrochlorideAlso: NDC 10920-601, NDC 51634-0014Doxapram hydrocholoride oral suspension | Drug | Sequence A - Hydrocodone alone followed by combined (hydrocodone + doxapram), Sequence B - Combined (hydrocodone + doxapram) followed by hydrocodone alone |
Primary outcome
Number of Participants With Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs
Time frame: Day 1 to Day 5
Number of participants with clinically meaningful changes from baseline in physical examination, vital signs, 12-lead ECG assessment and/or pulse oximetry
3 secondary outcomes
Plasma PK Parameters (Cmax)
Time frame: Day 2 and Day 4
Plasma PK Parameter (AUC0-24h)
Time frame: Day 2 and Day 4
Plasma PK Parameter (Tmax)
Time frame: Day 2 and Day 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results to be reported, after deidentification (text, tables, figures, and appendices).
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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.
Frank Lee, MD principal investigator
Frontage Clinical Services, Inc.
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 Hydrocodone Bitartrate and Hydrocodone Bitartrate + Doxapram Hydrochloride in people with Healthy and PK Drug-drug Interaction Study, run by Quivive Pharma, 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 9 inclusion and 17 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 5 Aug 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?
Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs (time frame: Day 1 to Day 5). 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 5 Aug 2026.