Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
To establish pharmacokinetics (PK), pharmacodynamics (PD), and adverse event (AE) profile of
tolvaptan administered as the modified-release (MR) formulation in ADPKD subjects. The goals
of this trial are two-fold:
1. To directly compare the immediate release (IR) and MR formulations
2. To determine the dose range and dose regimen for MR (dose finding)
Phase:
Phase 2
Details
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.