healthy volunteers
Conditions
Interventions
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
Sponsors
AMO UK
Eligibility
Inclusion criteria
Inclusion criteria: - Healthy male or female volunteers; - Age: 18 - 40 years; - Body mass index < 30 kg/m2; - Able to give informed consent.
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactMonique van Velzen
LUMC
Outcome results
None listed