Trial intelligence / Profile preview

PK, Safety, and PD of OPC-61815 in Healthy Chinese Males

NCT05439148Phase 1Completed

Sponsor
Otsuka Holdings
Start
Jun 2022
Primary completion
Sep 2022
Modality
Prodrugs/Conditional Activator Small Molecules
Countries
1
01

Overview

Phase 1, open-label trial of tolvaptan sodium phosphate in edema secondary to heart failure and heart failure (HF) (2 arms), sponsored by Otsuka Holdings. Primary endpoints: Time to Maximum Plasma Concentration at Day 9, Maximum Plasma Concentration at Day 9 and 6 more. Started Jun 2022; status: completed.

02

Drugs

tolvaptan sodium phosphate
03

Conditions

edema secondary to heart failureheart failure (HF)

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