Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: Healthy volunteers 1. Signed the informed consent form (ICF) and able to comply with the study requirements and restrictions listed therein; 2. Male and female subjects, age 18 to 70 years, inclusive; 3. 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; 4. Body Mass Index (BMI) 18 to 30 kg/m2, inclusive; 5. 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