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

NCT03254108 | Completed Results

• 2 other identifiers: 263-102-00001JapicCTI-173676
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (5)

OPC-61815 injection 2mg

EXPERIMENTAL

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 2mg

OPC-61815 injection 4mg

EXPERIMENTAL

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 4mg

OPC-61815 injection 8mg

EXPERIMENTAL

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 8mg

OPC-61815 injection 16mg

EXPERIMENTAL

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

Drug: OPC-61815 injection 16mg

Tolvaptan tablet 15mg

ACTIVE COMPARATOR

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

Drug: Tolvaptan tablet 15mg

Interventions

OPC-61815 injection 2mg DRUG

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

OPC-61815 injection 2mg

OPC-61815 injection 4mg DRUG

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 4mg

OPC-61815 injection 8mg DRUG

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 8mg

OPC-61815 injection 16mg DRUG

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 16mg

Tolvaptan tablet 15mg DRUG

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

Tolvaptan tablet 15mg

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present
• Subjects who are currently hospitalized or who are able to be hospitalized during the trial

You may not qualify if:

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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kanto, Japan

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Hiroaki Ono

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 18, 2017
• Study Start: November 6, 2017
• Primary Completion: April 14, 2018
• Study Completion: April 24, 2018
• Last Updated: July 28, 2021
• Results First Posted: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Locations

JP (1)