The effect of intravenous tianeptine on an established model of opioid-induced respiratory depression (OIRD) in healthy volunteers: a population pharmacokinetic and pharmacodynamic study
Recruiting
- Conditions
- healthy volunteers
- Registration Number
- NL-OMON24262
- Lead Sponsor
- AMO UK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 21
Inclusion Criteria
Healthy male or female volunteers;
- Age: 18 - 40 years;
- Body mass index < 30 kg/m2;
- Able to give informed consent.
Exclusion Criteria
- Known or suspected neuromuscular or a (family) history of any neuromuscular disease;
- A history of allergic reaction to food or medication including study medication;
- Any current or previous medical (including high blood pressure), neurological or psychiatric illness (including a history of anxiety);
- Alcohol abuse (> 21 units/week);
- History of ingestion/administration of opioids within the past 30 days;
- Illicit drug use in the past 30 days before inclusion;
- Pregnancy or lactation;
- Participation in any medical or drug trial in the month prior to the current study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In part 1 we will study the pharmacokinetics (PK) of intravenous tianeptine in 6 healthy volunteers. <br>In part 2 we will perform a pharmacokinetic-pharmacodynamic modeling study to assess the ability of intravenous tianeptine to reverse OIRD induced by administration of the opioid remifentanil.<br><br>In Part 1, the tianeptine plasma concentrations are the primary study end-point.<br>In Part 2 minute ventilation is the main study end-point.
- Secondary Outcome Measures
Name Time Method