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

Not Applicable

Completed

• Conditions: Congestive Heart Failure
• Interventions: Drug: Tolvaptan tablet 15mg; Drug: OPC-61815 injection 4mg; Drug: OPC-61815 injection 8mg; Drug: OPC-61815 injection 16mg; Drug: OPC-61815 injection 2mg

• Registration Number: NCT03254108
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-18
• Study Start: 2017-11-06
• Primary Completion: 2018-04-14
• Study Completion: 2018-04-24
• Status Verified: 2021-07
• Results First Submitted: 2021-07-08
• Results First Submitted QC: 2021-07-08
• Last Update Submitted: 2021-07-08
• Results First Posted: 2021-07-28
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tolvaptan tablet 15mg	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.
OPC-61815 injection 4mg	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.
OPC-61815 injection 8mg	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.
OPC-61815 injection 16mg	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.
OPC-61815 injection 2mg	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.

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of OPC-41061 on Day 1	Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug
Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC24h) on Day 1	Baseline, 1, 1.5, 2, 4, 6, 12 24 hours after the start of administration of investigational drug