drugset / Trial / NCT03931369

Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)

NCT03931369

NaSingle-groupOpen-labelBasic science

Summary

Tolvaptan is a new drug that specifically antagonizes the V2-receptor of antidiuretic hormone (ADH) and leads to water diuresis: During acute administration of tolvaptan, the main fear is to induce a too fast increase in plasma sodium concentration and in turn brain damageHowever, the tolvaptan-induced increase in plasma sodium concentration is expected to stimulate thirst, preventing major negative water balance. The investigators hypothesize that tolvaptan-induced increase in plasma osmolality (and sodium concentration) is dependent of thirst adaptation that is influenced by physiological factors, namely age and sex. To address the effect of a single oral administration of tolvaptan at a dosage used during hyponatremia (15 mg) under free water access in healthy volunteers. Primary outcome will be the maximal change in serum sodium concentration within the 6 hours following tolvaptan administration.

Timeline

Start
2019-09-06
Primary completion
2020-12-30
Completion
2020-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tolvaptan Small molecule 15 mg Oral

Indications

No indication recorded.