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

A Multicenter, Double-blind, Randomized, Active-controlled, Parallel-group Comparison Clinical Pharmacology Trial to Investigate the Dose of OPC-61815 Injection Equivalent to Tolvaptan 15-mg Tablet in Patients With Congestive Heart Failure

Sponsors

Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Source Otsuka Pharmaceutical Co., Ltd.
Brief Summary

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.

Overall Status Active, not recruiting
Start Date November 13, 2017
Completion Date February 2019
Primary Completion Date February 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Cmax on Day 1 of the treatment period Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug
AUC24h on Day1 of the treatment period Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug
Enrollment 61
Condition
Intervention

Intervention Type: Drug

Intervention Name: OPC-61815 injection 2mg

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

Arm Group Label: OPC-61815 injection 2mg

Intervention Type: Drug

Intervention Name: OPC-61815 injection 4mg

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

Arm Group Label: OPC-61815 injection 4mg

Intervention Type: Drug

Intervention Name: OPC-61815 injection 8mg

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

Arm Group Label: OPC-61815 injection 8mg

Intervention Type: Drug

Intervention Name: OPC-61815 injection 16mg

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

Arm Group Label: OPC-61815 injection 16mg

Intervention Type: Drug

Intervention Name: Tolvaptan tablet 15mg

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

Arm Group Label: Tolvaptan tablet 15mg

Eligibility

Criteria:

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

Gender: All

Minimum Age: 20 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Hiroaki Ono Study Director Otsuka Pharmaceutical Co., Ltd.
Location
Facility:
Location Countries

Japan

Verification Date

October 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: OPC-61815 injection 2mg

Type: Experimental

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

Label: OPC-61815 injection 4mg

Type: Experimental

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

Label: OPC-61815 injection 8mg

Type: Experimental

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

Label: OPC-61815 injection 16mg

Type: Experimental

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

Label: Tolvaptan tablet 15mg

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov