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ID
Source
Brief title
Health condition
healthy volunteers
Sponsors and support
Intervention
Outcome measures
Primary outcome
In part 1 we will study the pharmacokinetics (PK) of intravenous tianeptine in 6 healthy volunteers.
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.
In Part 1, the tianeptine plasma concentrations are the primary study end-point.
In Part 2 minute ventilation is the main study end-point.
Secondary outcome
none
Background summary
Rationale
The use of opioids comes with serious side effects of which opioid-induced respiratory depression (OIRD) is most dangerous. The use of drugs that antagonize OIRD but simultaneously do not affect (or even advance) analgesia would be a significant improvement over current OIRD treatment options. A possible novel option for respiratory stimulation could be with administration tianeptine. Tianeptine is an atypical antidepressant and cognitive enhancer medicine that can be administered orally or intravenously. It induces neuroplastic changes and modulates noradrenergic, dopaminergic and glutamatergic pathways. In the current experimental pharmacokinetic-pharmacodynamics modeling study we will investigate the effect of intravenous tianeptine. The study will have two parts. In part 1 we will study the pharmacokinetics (PK) of intravenous tianeptine in 6 healthy volunteers. 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 (using a double blind randomized placebo-controlled design, tianeptine:placebo = 1:1).
Study objective
Proof of concept: to study the effect of tianeptine on opioid-induced respiratory depression in healthy volunteers.
Study design
In part 1, all blood samples will be taken within 90 minutes following the start of infusion.
In part 2, continuous ventilatory measurements will be collected.
Intervention
In part 1 we will study the pharmacokinetics (PK) of intravenous tianeptine in 6 healthy volunteers. 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 (using a double blind randomized placebo-controlled design, tianeptine:placebo = 1:1).
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7907 |
| Other | METC Leiden Den Haag Delft : P18.249 |