15
Participants
Start Date
March 1, 2024
Primary Completion Date
March 18, 2025
Study Completion Date
March 18, 2025
Placebo
"Artificial SIAD induction:~* Oral water intake of 30ml/kg body weight in one hour (timepoint -2 to timepoint -1)~* Intravenous bolus of desmopressin 4 μg i.v. (Minirin®, Ferring AG) (timepoint -1)~* 300ml NaCl 0.45% (B. Braun Medical AG) over 1 hour (timepoint -1 to 0)~Study infusion (timepoint 0 to timepoint +3):~* 180-ml NaCl 0.45% infusion (placebo) over 3 hours (60ml per h)"
Apelin Low Dose
"Artificial SIAD induction:~* Oral water intake of 30ml/kg body weight in one hour (timepoint -2 to timepoint -1)~* Intravenous bolus of desmopressin 4 μg i.v. (Minirin®, Ferring AG) (timepoint -1)~* 300ml NaCl 0.45% (B. Braun Medical AG) over 1 hour (timepoint -1 to 0)~Study infusion (timepoint 0 to timepoint +3):~* 180-ml infusion of \[Pyr1\]apelin-13 in NaCl 0.45% over 3 hours at an infusion rate of 1 nmol/min (60ml per h)"
Apelin High Dose
"Artificial SIAD induction:~* Oral water intake of 30ml/kg body weight in one hour (timepoint -2 to timepoint -1)~* Intravenous bolus of desmopressin 4 μg i.v. (Minirin®, Ferring AG) (timepoint -1)~* 300ml NaCl 0.45% (B. Braun Medical AG) over 1 hour (timepoint -1 to 0)~Study infusion (timepoint 0 to timepoint +3):~* 180-ml infusion of \[Pyr1\]apelin-13 in NaCl 0.45% over 3 hours at an infusion rate of 10 nmol/min (60ml per h)"
Selected Apelin Dose
"Study infusions (timepoint 0 to timepoint +3):~* 180-ml NaCl 0.45% infusion (placebo) over 3 hours (60ml per h)~* 180-ml infusion of \[Pyr1\]apelin-13 in NaCl 0.45% over 3 hours based on the best performing apelin dose (from Low Dose or High Dose) in healthy volunteers corresponding to one of the following options:~ 1. at an infusion rate of 1 nmol/min (60ml per h) OR~ 2. at an infusion rate of 10 nmol/min (60ml per h)~In case both apelin dosis performed equally well in the healthy volunteers population the lower dose will be selected."
University Hospital Basel, Basel
University Hospital, Basel, Switzerland
OTHER