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Study of QEV-817 Oral Suspension with Hydrocodone and Doxapram

This study is looking at the safety and how well your body handles two medicines: hydrocodone bitartrate and doxapram hydrochloride. Researchers want to see if combining these medicines, or giving hydrocodone alone, causes any side effects in healthy volunteers. Before receiving the study medicines, all participants will be given naltrexone, which blocks the effects of opioids. The study will also measure how the medicines move through your body. To be in the study, you need to be a healthy adult between 18 and 55 years old. The main goals are to track any side effects and changes in lab tests, heart readings (ECG), and vital signs (like blood pressure and heart rate) from Day 1 to Day 5. The study is currently unclear on its recruitment status and plans to enroll 8 participants.

Study design
This is a Phase 1, double-blind, randomized crossover study involving 8 healthy male and female volunteers at a single site in the US.
What's involved
You would participate in a 28-day screening period, a four-day treatment period, and a one-day safety follow-up period. You would also need to avoid alcohol and strenuous exercise for 48 hours before treatment and until discharge.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a one-day safety follow-up after the treatment period, and safety will be monitored from Day 1 to Day 5.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06585163

Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension

Completed
PHASE1Ages 18–55InterventionalBasic science
Quivive Pharma, Inc.
~8 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Hydrocodone BitartrateHydrocodone Bitartrate + Doxapram Hydrochloride

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs
Measured over Day 1 to Day 5

Conditions

Healthy
PK Drug-drug Interaction Study

Explore related trials

Healthy

Where it's being run

1 sites across 1 states
New Jersey1

Study leadership

  • Frank Lee, MD · PRINCIPAL_INVESTIGATOR · Frontage Clinical Services, Inc.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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.
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.

What this trial measures

  • Number of Participants With Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital SignsDay 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