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

NCT02994394 | Completed Phase 1 Results

• 2 other identifiers: 156-102-00136JapicCTI-163471
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult Male

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (6)

OPC41061(15 mg) disintegrating tablet with water

EXPERIMENTAL

OPC41061 (15 mg) orally disintegrating tablet is administered with water.

Drug: OPC-41061

OPC-41061(15 mg) disintegrating tablet without water

EXPERIMENTAL

OPC41061 (15 mg) orally disintegrating tablet is administered without water.

Drug: OPC-41061

OPC-41061(15 mg) conventional tablet with water

EXPERIMENTAL

OPC-41061 (15 mg) conventional tablet is administered with water.

Drug: OPC-41061

OPC41061(30 mg) disintegrating tablet with water

EXPERIMENTAL

OPC41061 (30 mg) orally disintegrating tablet is administered with water.

Drug: OPC-41061

OPC-41061(30 mg) disintegrating tablet without water

EXPERIMENTAL

OPC41061 (30 mg) orally disintegrating tablet is administered without water.

Drug: OPC-41061

OPC-41061(30 mg) conventional tablet with water

EXPERIMENTAL

OPC-41061 (30 mg) conventional tablet is administered with water.

Drug: OPC-41061

Interventions

OPC-41061 DRUG

OPC-41061(15 mg) conventional tablet with water; OPC-41061(15 mg) disintegrating tablet without water; OPC-41061(30 mg) conventional tablet with water; OPC-41061(30 mg) disintegrating tablet without water; OPC41061(15 mg) disintegrating tablet with water; OPC41061(30 mg) disintegrating tablet with water

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kyusyu Region, Japan

Location

MeSH Terms

Interventions

Tolvaptan

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, Mr

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 15, 2016
• Study Start: January 6, 2017
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: June 28, 2021
• Results First Posted: June 28, 2021

Record last verified: 2021-06

Locations

JP (1)