NCT03254108 - Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 6, 2017

Primary Completion Date

April 14, 2018

Study Completion Date

April 24, 2018

Conditions

Congestive Heart Failure

Interventions

DRUG

OPC-61815 injection 2mg

Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.

DRUG

OPC-61815 injection 4mg

Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.

DRUG

OPC-61815 injection 8mg

Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.

DRUG

OPC-61815 injection 16mg

Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.

DRUG

Tolvaptan tablet 15mg

Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.

Trial Locations (1)

Kanto