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Could a common drug change how opioids work in the body?

NCT ID NCT06585163

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This early-stage trial is testing whether an experimental oral suspension called QEV-817 (doxapram) changes how the body handles the opioid hydrocodone. Healthy volunteers aged 18-55 will receive hydrocodone with and without doxapram to compare safety and drug levels in the blood. The goal is to understand potential interactions and gather initial safety data.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
doxapram hydrochloride (QEV-817) oral suspension, given with and without hydrocodone bitartrate
What this could lead to
If doxapram safely changes how hydrocodone is processed, it might help reduce opioid side effects or improve pain management strategies.
What could go wrong
This is a very early, small study in healthy volunteers, not patients. Results may not apply to real-world use, and safety or drug interactions could differ.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

8 people

The number who actually took part.

Started

Aug 2025

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria - include but are not limited to: * 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 Criteria - include but are not limited to: * 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Frontage Clinical Services, Inc.

    Secaucus, New Jersey, 07094, United States

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