Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers. (NCT06306391) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers.
Spain8 participantsStarted 2024-03-05
Plain-language summary
This is a phase I interventional clinical trial and the aim will be to characterize the PK and PD of two formulations of naloxone (intranasal and intravenous) in healthy subjects, which will be used to verify/validate nasal-CNS-PBPK (Physiologically Based Pharmacokinetic) model predictions following intranasal dosing.
Who can participate
Age range18 Years – 55 Years
SexALL
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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.
What they're measuring
1
Effects of Naloxone on Heart Rate (HR).
Timeframe: Up to 6 hours.
2
Effects of Naloxone on Systolic Blood Pressure (SBP).
Timeframe: Up to 6 hours.
3
Effects of Naloxone on Diastolic Blood Pressure (DBP).
Timeframe: Up to 6 hours
4
Cmax
Timeframe: Blood samples were taken pre-dose and up to 24 hours after start of each Dose
5
Tmax
Timeframe: Blood samples were taken pre-dose and up to 24 hours after start of each Dose