Healthy Adult MalePhase 1NCT02994394

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

A Phase 1 study testing OPC-41061 in people with Healthy Adult Male, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 39 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Adult Male
What is being tested?: OPC-41061
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteJapan
Study dates: 6 Jan 2017to 28 Feb 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 39 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Kyusyu Region

Other trials in Japan

About this study

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
Being tested: OPC-41061

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPC-41061Drug

Study groups in NCT02994394
Study group	Role	What they receive
OPC41061(15 mg) disintegrating tablet with water	Experimental	OPC41061 (15 mg) orally disintegrating tablet is administered with water. Receives: Drug: OPC-41061
OPC-41061(15 mg) disintegrating tablet without water	Experimental	OPC41061 (15 mg) orally disintegrating tablet is administered without water. Receives: Drug: OPC-41061
OPC-41061(15 mg) conventional tablet with water	Experimental	OPC-41061 (15 mg) conventional tablet is administered with water. Receives: Drug: OPC-41061
OPC41061(30 mg) disintegrating tablet with water	Experimental	OPC41061 (30 mg) orally disintegrating tablet is administered with water. Receives: Drug: OPC-41061
OPC-41061(30 mg) disintegrating tablet without water	Experimental	OPC41061 (30 mg) orally disintegrating tablet is administered without water. Receives: Drug: OPC-41061
OPC-41061(30 mg) conventional tablet with water	Experimental	OPC-41061 (30 mg) conventional tablet is administered with water. Receives: Drug: OPC-41061

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 201728 Feb 2017

First posted15 Dec 2016 (estimated)
Study start6 Jan 2017
Primary completion28 Feb 2017
Study completion28 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02994394
Sponsor's protocol ID: 156-102-00136
Other IDs: JapicCTI-163471
Status last verified: Jun 2021
First submitted: 13 Dec 2016
Last updated: 28 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Adult Male trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects
ClinicalTrials.gov ID: NCT02994394
Acronym / sponsor ID: 156-102-00136
Conditions: Healthy Adult Male
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 6 Jan 2017 (actual)
Primary completion: 28 Feb 2017 (actual)
Study completion: 28 Feb 2017 (actual)
First posted: 15 Dec 2016 (estimated)
Results: Posted 28 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
OPC41061(15 mg) disintegrating tablet with water	Experimental	Drug: OPC-41061OPC41061 (15 mg) orally disintegrating tablet is administered with water.
OPC-41061(15 mg) disintegrating tablet without water	Experimental	Drug: OPC-41061OPC41061 (15 mg) orally disintegrating tablet is administered without water.
OPC-41061(15 mg) conventional tablet with water	Experimental	Drug: OPC-41061OPC-41061 (15 mg) conventional tablet is administered with water.
OPC41061(30 mg) disintegrating tablet with water	Experimental	Drug: OPC-41061OPC41061 (30 mg) orally disintegrating tablet is administered with water.
OPC-41061(30 mg) disintegrating tablet without water	Experimental	Drug: OPC-41061OPC41061 (30 mg) orally disintegrating tablet is administered without water.
OPC-41061(30 mg) conventional tablet with water	Experimental	Drug: OPC-41061OPC-41061 (30 mg) conventional tablet is administered with water.

Who may qualify

Ages: 20 to 39 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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

Primary outcome

Maximum Plasma Concentration (Cmax) of Tolvaptan
Time frame: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose
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.
Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t (AUCt) of of Tolvaptan
Time frame: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose
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.

Results and safety

Results posted to the registry on 28 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Conventional Tablet, Then OD Tablet Without Water, Then OD Tablet With Water	14	14
Cohort 1: OD Tablet With Water, Then Conventional Tablet, Then OD Tablet Without Water	14	14
Cohort 1: OD Tablet Without Water, Then OD Tablet With Water, Then Conventional Tablet	14	13
Cohort 2: Conventional Tablet, Then OD Tablet Without Water, Then OD Tablet With Water	14	14
Cohort 2: OD Tablet With Water, Then Conventional Tablet, Then OD Tablet Without Water	14	14
Cohort 2: OD Tablet Without Water, Then OD Tablet With Water, Then Conventional Tablet	14	14

Primary outcome: Maximum Plasma Concentration (Cmax) of Tolvaptan

Time frame: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Cohort 1: 15 mg Conventional Tablet n = 39	Cohort 1: 15 mg OD Tablet Without Water n = 39	Cohort 1: 15 mg OD Tablet With Water n = 39	Cohort 2: 30 mg Conventional Tablet n = 41	Cohort 2: 30 mg OD Tablet Without Water n = 41	Cohort 2: 30 mg OD Tablet With Water n = 41
Value	131 (71.0)	149 (72.6)	125 (63.1)	203 (72.7)	218 (56.0)	198 (54.7)

Population analysed: Bioequivalence analysis set: all subjects with both AUCt and Cmax values across Period 1, Period 2, and Period 3.

Primary outcome: Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t (AUCt) of of Tolvaptan

Time frame: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Cohort 1: 15 mg Conventional Tablet n = 39	Cohort 1: 15 mg OD Tablet Without Water n = 39	Cohort 1: 15 mg OD Tablet With Water n = 39	Cohort 2: 30 mg Conventional Tablet n = 41	Cohort 2: 30 mg OD Tablet Without Water n = 41	Cohort 2: 30 mg OD Tablet With Water n = 41
Value	697 (440)	674 (361)	685 (392)	1120 (334)	1130 (306)	1110 (312)

Population analysed: Bioequivalence analysis set: all subjects with both AUCt and Cmax values across Period 1, Period 2, and Period 3.

Adverse events

Time frame: Treatment-emergent adverse events were collected during the treatment period (8 days). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: 15 mg Conventional Tablet	0 of 41 (0%)	1 of 41 (2.4%)	0 of 41
Cohort 1: 15 mg OD Tablet Without Water	0 of 41 (0%)	1 of 41 (2.4%)	0 of 41
Cohort 1: 15 mg OD Tablet With Water	0 of 41 (0%)	2 of 41 (4.9%)	0 of 41
Cohort 2: 30 mg Conventional Tablet	0 of 42 (0%)	1 of 42 (2.4%)	0 of 42
Cohort 2: 30 mg OD Tablet Without Water	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Cohort 2: 30 mg OD Tablet With Water	0 of 41 (0%)	0 of 41 (0%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hiroaki Ono, Mr study director

Otsuka Pharmaceutical Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OPC-41061 in people with Healthy Adult Male, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) of Tolvaptan (time frame: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02994394.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.