Effect of a pain killer on breathing and another drug that stimulates breathing

Phase 1

Recruiting

Conditions: none, healthy subjects only
Therapeutic area: Phenomena and Processes [G] - Physiological processes [G07]
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: CTIS2023-503912-34-00

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 18

Inclusion Criteria

Age 18-40 years, Body Mass Index 19-30 kg/m2, Able to read and understand the subject information

Exclusion Criteria

A medical history of medical or psychiatric disease, any allergy to food or medication, weekly ethanol intake of more than 3 units/day or more than 21 units/week in women and 5 units/day and 35 units/week in men, pregnancy or lactation, 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 urine 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, participation in an investigational drug trial in the 3 months before the current study, illicit drug use in the 30 days before the current study, a positive drug urine dipstick on the screening or study days

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We will investigate the ability of an intravenous infusion of L-NAC on opioid-induced respiratory depression induced by fentanyl;Secondary Objective: Assess effects of L-NAC or placebo on pH, arterial and end-tidal PCO2, oxygen saturation and respiratory rate;Primary end point(s): Minute ventilation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):End-tidal carbon dioxide partial pressure;Secondary end point(s):Respiratory frequency;Secondary end point(s):Tidal volume;Secondary end point(s):Arterial blood gas analyses;Secondary end point(s):Blood plasma concentrations of fentanyl and L-NAC