Study: NCT06277336

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apelin Low Dose
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apelin Low Dose
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apelin Low Dose
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apelin Low Dose
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apelin Low Dose
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apelin Low Dose
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apelin High Dose
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apelin High Dose
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apelin High Dose
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apelin High Dose
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apelin High Dose
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apelin High Dose
Description: 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)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Selected Apelin Dose
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Selected Apelin Dose
Description: 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.