Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists (NCT05338632) | Clinical Trial Compass
RecruitingPhase 1
Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists
Netherlands24 participantsStarted 2022-06-24
Plain-language summary
n this pharmacokinetic/pharmacodynamic modelling study we will determine the ability of intranasal and intravenous naloxone and intravenous nalmefene to reverse opioid (fentanyl and sufentanil)- induced respiratory depression in healthy volunteers and chronic opioid users to develop dosing recommendations in case of opioid-induced respiratory depression from an opioid overdose in clinical practice and in the out-of-hospital overdose.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Signed the informed consent form (ICF) and able to comply with the study requirements and restrictions listed therein;
✓. Male and female subjects, age 18 to 70 years, inclusive;
✓. Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative serum pregnancy test prior to enrolment and must agree to use a medically acceptable means of contraception from screening through at least 1 month after the last dose of study drug;
✓. Body Mass Index (BMI) 18 to 30 kg/m2, inclusive;
✓. Healthy as defined by the Investigator, based on a medical evaluation that includes the subject's medical and surgical history, physical examination, vital signs, lab chemistry: estimated glomerular filtration rate \>60 mL/min as estimated by the CKD-EPI equation, and AST or ALT levels \< 3.0 times the upper limit of normal at screening, and negative serology tests for HIV, acute hepatitis B, or acute hepatitis C;
✓. No history of substance use disorder;
✓. Signed the consent form and able to comply with the requirements and restrictions listed therein;
✓. Males or females age 18 to 70 years, inclusive;
Exclusion criteria
✕. Currently meet the criteria for diagnosis of substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria on any substance;
✕
What they're measuring
1
Minute ventilation
Timeframe: Minute ventilation will be measured for up to 180 minutes following the start of opioid infusion
2
Plasma concentration sufentanil/fentanyl
Timeframe: at 2,5,10,15,20 and 30 minutes following opioid infusion and following every administration of intranasal/intravenous naloxone or nalmefene
3
Plasma concentration naloxone
Timeframe: at 2,5,10,15,20 and 30 minutes following opioid infusion and following every administration of intranasal/intravenous naloxone or nalmefene
. Any other active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;
✕. Consume, on average, \>27 20 units/week of alcohol in men and \> 20 13 units/week of alcohol in women (1 unit = 1 glass (250 mL) beer, 125 mL glass of wine or 25 mL of 40% spirit);
✕. Previous or current treatment with opioid agonist, partial agonist, or antagonist treatment within 30 days prior to the first study drug administration;
✕. Significant traumatic injury, major surgery, or open biopsy within the prior 4 weeks of informed consent;
✕. History of suicidal ideation within 30 days prior to informed consent or history of a suicide attempt in the 6 months prior to informed consent;
✕. Measured systolic blood pressure greater than 160 or less than 95 mmHg or diastolic pressure greater than 95 mmHg at screening;
✕. History or presence of allergic response to fentanyl, sufentanil or naloxone;