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

Otsuka

Status: Completed

Conditions: Congestive Heart Failure

Treatments: Drug: OPC-61815 injection 4mg; Drug: Tolvaptan tablet 15mg; Drug: OPC-61815 injection 2mg; Drug: OPC-61815 injection 8mg; Drug: OPC-61815 injection 16mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03254108

263-102-00001

JapicCTI-173676 (Other Identifier)

Details and patient eligibility

About

The dose for intravenous administration of OPC-61815 achieving tolvaptan exposure equivalent to that for oral administration of tolvaptan 15-mg tablet will be investigated by administering OPC-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with congestive heart failure.

Enrollment: 61 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects who are currently on treatment with any of the following diuretics

   • Loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher
   • Concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose
   • Concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose

2. Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present

3. Subjects who are currently hospitalized or who are able to be hospitalized during the trial

Exclusion criteria

1. Subjects with acute heart failure
2. Subjects with a history of hypersensitivity to any of ingredients of OPC-61815 or tolvaptan
3. Subjects who are unable to sense thirst or who have difficulty with fluid intake

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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61 participants in 5 patient groups

OPC-61815 injection 2mg

Experimental group

Description:

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

Treatment:

Drug: OPC-61815 injection 2mg

OPC-61815 injection 4mg

Experimental group

Description:

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

Treatment:

Drug: OPC-61815 injection 4mg

OPC-61815 injection 8mg

Experimental group

Description:

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

Treatment:

Drug: OPC-61815 injection 8mg

OPC-61815 injection 16mg

Experimental group

Description:

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

Treatment:

Drug: OPC-61815 injection 16mg

Tolvaptan tablet 15mg

Active Comparator group

Description:

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

Treatment:

Drug: Tolvaptan tablet 15mg