Effects of Intravenous [Pyr1]Apelin-13 on Healthy Volunteers With Artificially Induced SIAD

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

March 18, 2025

Study Completion Date

March 18, 2025

Conditions
SIAD - Syndrome of Inappropriate AntidiuresisHyponatremia
Interventions
DRUG

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)"

DRUG

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)"

DRUG

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)"

DRUG

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."

Trial Locations (1)

4031

University Hospital Basel, Basel

All Listed Sponsors
lead

University Hospital, Basel, Switzerland

OTHER

NCT06277336 - Effects of Intravenous [Pyr1]Apelin-13 on Healthy Volunteers With Artificially Induced SIAD | Biotech Hunter | Biotech Hunter