NCT02009878

A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

A Phase 1b, Multicenter, Pilot, Randomized, Double-blind Trial to Determine the Pharmacokinetics and Pharmacodynamics of Orally Administered Tolvaptan 3.75, 7.5, and 15 mg Tablets in Subjects With Syndrome of Inappropriate Antidiuretic Hormone Secretion

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate how the body handles and metabolizes (PK) the various doses of the drug Tolvaptan, and what the effect (PD) of the various doses of Tolvaptan are on the content of "salt" in blood and urine

Conditions

• Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

Interventions

Type	Name	Description
DRUG	tolvaptan	Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-12-12
• Last updated: 2016-05-16
• Results posted: 2016-05-16

Locations

14 sites across 7 countries: Czechia, Denmark, Germany, Hungary, Spain, Sweden, United Kingdom