Understanding how naloxone works in healthy volunteers

Physiologically Based Pharmacokinetic Modelling of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers.

This study tests how two forms of naloxone work in healthy adults to see how well the body absorbs and processes the medication.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Parc de Salut Mar (other)
• Locations: 1 site (Barcelona)
• Trial ID: NCT06306391 on ClinicalTrials.gov

What this trial studies

This phase I interventional clinical trial aims to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of two formulations of naloxone, administered intravenously and intranasally, in healthy subjects. The study will verify and validate predictions made by a nasal-CNS-PBPK model following intranasal dosing. Healthy volunteers aged 18 to 55 will participate, and their responses to the different formulations will be closely monitored to gather data on how naloxone is absorbed and processed in the body.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy male or female volunteers aged 18 to 55 with a BMI between 18 and 30.

Not a fit: Patients with a history of substance use disorders or those currently using prescribed opiates will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of naloxone's effectiveness and optimize its use in emergency situations involving opioid overdoses.

How similar studies have performed: While this study focuses on a specific pharmacokinetic analysis, similar studies have shown promise in understanding drug formulations and their effects, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Healthy male or female volunteers according to physical examination, vital signs (blood pressure, heart rate and body temperature), ECG and safety laboratory parameters and results should be within normal ranges or considered as non-clinically relevant by the investigator.
* Age ≥ 18 and ≤ 55 years.
* Body mass index (BMI) ≥ 18 and ≤ 30.
* Able/willing to be compliant with the study restrictions.
* Able to read Spanish and adhere to study requirements.
* Signed informed consent prior to any study-mandated procedure.

Exclusion Criteria:

* Life-time substance use disorders (SUD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
* Consumption of prescribed opiates (in the last 6 months).
* Smoking.
* History of or ongoing clinically relevant diseases or conditions.
* Being under any administrative or legal supervision.
* Pregnancy and breastfeeding
* Positive blood or urine test for drugs of abuse or alcohol breath test prior to study drug administration.
* Life-time history of mental diseases.
* History of anxiety or depression not completely recovered within 12 months prior to study drug administration, as assessed by the Dual Diagnosis Screening Interview (DDSI).
* Any other clinically relevant disease or condition that in the judgment of the investigator might interfere with the subject's ability to comply with study procedures or requirements and/or bias the interpretation of the study results and/or jeopardize the subject's safety.
* Ongoing gastrointestinal diseases or history of gastrointestinal surgery affecting absorption.
* Subjects with a clinically significant disease within one month prior to study drug administration.
* Any clinically relevant findings in physical examination, vital signs, 12-lead ECG and safety laboratory parameters.
* Positive hepatitis or HIV test.
* Known hypersensitivity to any drug or drug excipients.
* Use of drugs known to induce or inhibit hepatic drug metabolism (e.g., cimetidine) within one month prior to study administration or during the study and use of citrus juice during the study.
* Any prescription or over-the-counter (OTC) product including herbal, homeopathic, vitamins, minerals and nutritional supplements within one week prior to study drug administration.
* Intake of foods or beverages containing xanthine (more than 5 units of coffee, tea or cola drinks per day).
* Donation of blood or plasma within one month prior to study drug administration or transfusion of blood or plasma for medical/surgical reasons or intention to donate blood or plasma within one month after study drug administration.
* History of inadequate venous access and/or experience of difficulty donating blood.
* Subject included in a clinical study within 3 months prior to study drug administration.

Where this trial is running

Barcelona

• IMIM (Hospital del Mar Medical Research Institute) — Barcelona, Spain (RECRUITING)

Study contacts

• Study coordinator: Ana Maria Aldea Perona, PhD

Conditions: Healthy