A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects

To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15 and 30 mg in healthy adult male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Adult Male
• Intervention / Treatment: Drug: OPC-41061

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kyusyu Region, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Body weight of at least 50.0 kg
• BMI [body weight in kg / (height in m)2] of at least 17.6 kg/m2 and less than 25.0 kg/m2
• Judged by the investigator or subinvestigator to be capable of providing written informed consent prior to the start of any trial-related procedures and capable of complying with the trial procedures for this study.

Exclusion Criteria:

• Judged by the investigator,subinvestigator, or sponsor to have a clinically significant abnormality in results of the screening examination (including a notable deviation from the site's standard values) or a medical history that could place the subject at risk or affect the evaluation of drug absorption, distribution, metabolism, or excretion
• History of alcohol or drug dependence or abuse within 2 years prior to the trial
• History or current infection with hepatitis or acquired immunodeficiency syndrome (AIDS) or carrier of hepatitis B positive surface antigen (HBsAg), anti-hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis based on the results of the Treponema pallidum (TP) antibody test or rapid plasma reagin (RPR) test
• History of any severe drug allergy
• Positive results in alcohol screening test or urine drug screening test at time of screening examination or trial site admission
• Use of any other investigational medicinal product (IMP) within 120 days prior to Period 1 IMP administration
• Consumption of any food or beverage containing St. John's wort within 14 days prior to Period 1 IMP administration
• Consumption of any food or beverage containing grapefruit, Seville orange, or star fruit within 7 days prior to Period 1 IMP administration
• Judgment by the investigator or subinvestigator that the subject should not participate in the study for any other reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OPC41061(15 mg) disintegrating tablet with water; OPC41061 (15 mg) orally disintegrating tablet is administered with water.	Drug: OPC-41061
Experimental: OPC-41061(15 mg) disintegrating tablet without water; OPC41061 (15 mg) orally disintegrating tablet is administered without water.	Drug: OPC-41061
Experimental: OPC-41061(15 mg) conventional tablet with water; OPC-41061 (15 mg) conventional tablet is administered with water.	Drug: OPC-41061
Experimental: OPC41061(30 mg) disintegrating tablet with water; OPC41061 (30 mg) orally disintegrating tablet is administered with water.	Drug: OPC-41061
Experimental: OPC-41061(30 mg) disintegrating tablet without water; OPC41061 (30 mg) orally disintegrating tablet is administered without water.	Drug: OPC-41061
Experimental: OPC-41061(30 mg) conventional tablet with water; OPC-41061 (30 mg) conventional tablet is administered with water.	Drug: OPC-41061

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration (Cmax) of Tolvaptan	Blood sampling for plasma tolvaptan concentration before IMP administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hours postdose in each period in Cohort 1 and 2 was performed for pharmacokinetic evaluation.	Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose
Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t (AUCt) of of Tolvaptan	Blood sampling for plasma tolvaptan concentration before IMP administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hours postdose in each period in Cohort 1 and 2 was performed for pharmacokinetic evaluation.	Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2017
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimate): December 15, 2016

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 6, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Antidiuretic Hormone Receptor Antagonists; Tolvaptan
• Other Study ID Numbers: 156-102-00136; JapicCTI-163471 (Other Identifier: Japic)