Japanese Healthy Adult MalePhase 1NCT03808493

A Bioequivalence (BE) Study of TAK-438 Orally Disintegrating (OD) Tablet

A Phase 1 study testing TAK-438 OD and TAK-438 in people with Japanese Healthy Adult Male, run by Takeda 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

The purpose of this study is to evaluate the BE of single oral dose of TAK-438 OD 20 milligram (mg) tablet without water and TAK-438 20 mg tablet with water (Study 1), and TAK-438 OD 20 mg tablet with water and TAK-438 20 mg tablet with water (Study 2) in Japanese healthy adult male participants. Read more about this study

Who is it for?: Ages 20 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Japanese Healthy Adult Male
What is being tested?: TAK-438 OD and TAK-438
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteJapan
Study dates: 30 Jan 2019to 12 Mar 2019
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 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
The participant is a healthy Japanese adult male, aged 20 to 60 years, inclusive, at the time of informed consent.
The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.5 to 25.0 kilogram per square meter (kg/m^2), inclusive at Screening.
The participant must be a current nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months prior to the start of study drug administration in Period 1.
The participant must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead electrocardiogram (ECG), and vital sign measurements performed at the Screening Visit and prior to the start of study drug administration in Period 1.

Who cannot join

The participant has received any investigational compound within 16 weeks (112 days) prior to the start of study drug administration in Period 1.
The participant has received TAK-438 in a previous clinical study or as a therapeutic agent.
The participant is an immediate family member of or a study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease or other abnormality (other than the disease being studied), which may impact the ability of the participant to participate in the study or potentially confound its results.
The participant has hypersensitivity to any component of TAK-438 OD tablet or TAK-438 tablet.
The participant has a positive urine drug result for drugs of abuse at Screening.

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The participant has a history of drug or alcohol abuse within 2 years prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
The participant has taken any excluded medication, supplements, or food products during the specified time periods.
The participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis), frequent (more than once per week) occurrence of heartburn, or any surgical intervention.
The participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1.
The participant has a positive test result for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at Screening.
The participant has poor peripheral venous access.
The participant has undergone whole blood collection of at least 200 milliliter (mL) within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of study drug administration in Period 1.
The participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of study drug administration in Period 1.
The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of study drug administration in Period 1.
The participant has a Screening or Check-in (Day -1) ECG that was abnormal (clinically significant).
The participant has abnormal Screening laboratory values that suggest a clinically significant underlying disease or participant with the following laboratory abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limits of normal (ULN).
The participant who, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Sekino Clinical Pharmacology Clininc
Toshima-ku, Tokyo

Other trials in Japan

About this study

Official title: A Randomized, Open-Label, Single-Dose, 2×2 Crossover Phase 1 Study to Evaluate the Bioequivalence of TAK-438 OD (Orally Disintegrating) 20 mg Tablet When Administered Without Water (Study 1) or With Water (Study 2) and TAK-438 20 mg Tablet When Administered With Water in Japanese Healthy Volunteer Male Subjects

Read the detailed description

The drug being tested in this study is called TAK-438 OD tablet. TAK-438 OD tablet is being tested in Japanese healthy adult men. This study will evaluate bioequivalence of single oral dose of TAK-438 OD 20 mg tablet without water and TAK-438 20 mg tablet with water (Study 1), and TAK-438 OD 20 mg tablet with water and TAK-438 20 mg tablet with water (Study 2).

The study will enroll up to 144 participants in total (Study 1 + 2). In Study 1 and 2, participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups;

Study 1:

TAK-438 OD 20 mg tablet without water (Period 1) + TAK-438 20 mg tablet with water (Period 2)
TAK-438 20 mg tablet with water (Period 1) + TAK-438 OD 20 mg tablet without water (Period 2)

Study 2:

TAK-438 OD 20 mg tablet with water (Period 1) + TAK-438 20 mg tablet with water (Period 2)
TAK-438 20 mg tablet with water (Period 1) + TAK-438 OD 20 mg tablet with water (Period 2)

This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 11 days. Participants will make two visits to the clinic and be hospitalized for four days each in Periods 1 and 2.

Conditions: Japanese Healthy Adult Male
Being tested: TAK-438 OD, TAK-438
Keywords: Drug Therapy

What participants receive

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

TAK-438 ODDrug
TAK-438 OD tablet
TAK-438Drug
TAK-438 tablet

Study groups in NCT03808493
Study group	Role	What they receive
Study 1, TAK-438 OD + TAK-438	Experimental	One TAK-438 OD 20 mg tablet, orally without water under fasted condition, on Period 1 Day 1 in Study 1 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 20 mg tablet, orally with water under fasted condition, on Period 2 Day 1 in Study 1 (Day 9). Receives: Drug: TAK-438 OD; Drug: TAK-438
Study 1, TAK-438 + TAK-438 OD	Experimental	One TAK-438 20 mg tablet, orally with water under fasted condition, on Period 1 Day 1 in Study 1 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 OD 20 mg tablet, orally without water under fasted condition, on Period 2 Day 1 in Study 1 (Day 9). Receives: Drug: TAK-438 OD; Drug: TAK-438
Study 2, TAK-438 OD + TAK-438	Experimental	One TAK-438 OD 20 mg tablet, orally with water under fasted condition, on Period 1 Day 1 in Study 2 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 20 mg tablet, orally with water under fasted condition, on Period 2 Day 1 in Study 2 (Day 9). Receives: Drug: TAK-438 OD; Drug: TAK-438
Study 2, TAK-438 + TAK-438 OD	Experimental	One TAK-438 20 mg tablet, orally with water under fasted condition, on Period 1 Day 1 in Study 2 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 OD 20 mg tablet, orally with water under fasted condition, on Period 2 Day 1 in Study 2 (Day 9). Receives: Drug: TAK-438 OD; Drug: TAK-438

What is being measured

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

AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Plasma Concentration for TAK-438 Free Base (TAK-438F)
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-438F
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose

Secondary outcomes (4)

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose
Tmax: Time of First Occurrence of Maximum Plasma Concentration (Cmax) for TAK-438F
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose
MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-438F
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose
λz: Terminal Disposition Phase Rate Constant for TAK-438F
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose

Timeline

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

30 Jan 201912 Mar 2019

First posted17 Jan 2019
Study start30 Jan 2019
Primary completion12 Mar 2019
Study completion12 Mar 2019

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 Japanese Healthy Adult MaleStudies of the same condition, open and under way.
More trials run by TakedaThe 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03808493
Sponsor's protocol ID: TAK-438ODT-1001
Other IDs: U1111-1225-5005, JapicCTI-194587
Status last verified: Mar 2020
First submitted: 16 Jan 2019
Last updated: 7 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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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Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Single-Dose, 2×2 Crossover Phase 1 Study to Evaluate the Bioequivalence of TAK-438 OD (Orally Disintegrating) 20 mg Tablet When Administered Without Water (Study 1) or With Water (Study 2) and TAK-438 20 mg Tablet When Administered With Water in Japanese Healthy Volunteer Male Subjects
ClinicalTrials.gov ID: NCT03808493
Acronym / sponsor ID: TAK-438ODT-1001
Conditions: Japanese Healthy Adult Male
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 30 Jan 2019 (actual)
Primary completion: 12 Mar 2019 (actual)
Study completion: 12 Mar 2019 (actual)
First posted: 17 Jan 2019 (actual)
Results: Posted 24 Mar 2020

Clinical summary

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

Detailed description

The study will enroll up to 144 participants in total (Study 1 + 2). In Study 1 and 2, participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups;

Study 1:

TAK-438 OD 20 mg tablet without water (Period 1) + TAK-438 20 mg tablet with water (Period 2)
TAK-438 20 mg tablet with water (Period 1) + TAK-438 OD 20 mg tablet without water (Period 2)

Study 2:

TAK-438 OD 20 mg tablet with water (Period 1) + TAK-438 20 mg tablet with water (Period 2)
TAK-438 20 mg tablet with water (Period 1) + TAK-438 OD 20 mg tablet with water (Period 2)

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Study 1, TAK-438 OD + TAK-438	Experimental	Drug: TAK-438 OD, Drug: TAK-438One TAK-438 OD 20 mg tablet, orally without water under fasted condition, on Period 1 Day 1 in Study 1 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 20 mg tablet, orally with water under fasted condition, on Period 2 Day 1 in Study 1 (Day 9).
Study 1, TAK-438 + TAK-438 OD	Experimental	Drug: TAK-438 OD, Drug: TAK-438One TAK-438 20 mg tablet, orally with water under fasted condition, on Period 1 Day 1 in Study 1 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 OD 20 mg tablet, orally without water under fasted condition, on Period 2 Day 1 in Study 1 (Day 9).
Study 2, TAK-438 OD + TAK-438	Experimental	Drug: TAK-438 OD, Drug: TAK-438One TAK-438 OD 20 mg tablet, orally with water under fasted condition, on Period 1 Day 1 in Study 2 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 20 mg tablet, orally with water under fasted condition, on Period 2 Day 1 in Study 2 (Day 9).
Study 2, TAK-438 + TAK-438 OD	Experimental	Drug: TAK-438 OD, Drug: TAK-438One TAK-438 20 mg tablet, orally with water under fasted condition, on Period 1 Day 1 in Study 2 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 OD 20 mg tablet, orally with water under fasted condition, on Period 2 Day 1 in Study 2 (Day 9).

Who may qualify

Ages: 20 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
The participant is a healthy Japanese adult male, aged 20 to 60 years, inclusive, at the time of informed consent.
The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.5 to 25.0 kilogram per square meter (kg/m^2), inclusive at Screening.
The participant must be a current nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months prior to the start of study drug administration in Period 1.

Key exclusion criteria (18 listed)

The participant has received any investigational compound within 16 weeks (112 days) prior to the start of study drug administration in Period 1.
The participant has received TAK-438 in a previous clinical study or as a therapeutic agent.
The participant is an immediate family member of or a study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease or other abnormality (other than the disease being studied), which may impact the ability of the participant to participate in the study or potentially confound its results.
The participant has hypersensitivity to any component of TAK-438 OD tablet or TAK-438 tablet.

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
TAK-438 ODTAK-438 OD tablet	Drug	Study 1, TAK-438 + TAK-438 OD, Study 1, TAK-438 OD + TAK-438, Study 2, TAK-438 + TAK-438 OD, Study 2, TAK-438 OD + TAK-438
TAK-438TAK-438 tablet	Drug	Study 1, TAK-438 + TAK-438 OD, Study 1, TAK-438 OD + TAK-438, Study 2, TAK-438 + TAK-438 OD, Study 2, TAK-438 OD + TAK-438

Primary outcome

AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Plasma Concentration for TAK-438 Free Base (TAK-438F)
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-438F
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose

4 secondary outcomes

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose
Tmax: Time of First Occurrence of Maximum Plasma Concentration (Cmax) for TAK-438F
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose
MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-438F
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose
λz: Terminal Disposition Phase Rate Constant for TAK-438F
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose

Results and safety

Results posted to the registry on 24 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pilot BE Study 1, Sequence A: TAK-438 OD 20 mg + TAK-438 20 mg	12	12
Pilot BE Study 1, Sequence B: TAK-438 20 mg + TAK-438 OD 20 mg	12	12
Pilot BE Study 2, Sequence C: TAK-438 OD 20 mg + TAK-438 20 mg	12	12
Pilot BE Study 2, Sequence D: TAK-438 20 mg + TAK-438 OD 20 mg	12	12

Primary outcome: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Plasma Concentration for TAK-438 Free Base (TAK-438F)

Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose. Geometric mean (Standard Deviation). Unit: hour*nanogram per milliliter (h*ng/mL)

Measure	Pilot BE Study 1: TAK-438 OD 20 mg n = 24	Pilot BE Study 1: TAK-438 20 mg n = 24	Pilot BE Study 2: TAK-438 OD 20 mg n = 24	Pilot BE Study 2: TAK-438 20 mg n = 24
Value	190.2 (67.984)	194.3 (67.693)	201.6 (81.799)	201.2 (75.813)

Pilot BE Study 1: TAK-438 OD 20 mg vs Pilot BE Study 1: TAK-438 20 mg: LS-Means Difference: -0.0211 (90% CI -0.0752 to 0.0329)
Pilot BE Study 2: TAK-438 OD 20 mg vs Pilot BE Study 2: TAK-438 20 mg: LS-Means Difference: 0.0019 (90% CI -0.0778 to 0.0815)

Population analysed: The pharmacokinetic (PK) analysis set was defined as all participants who received at least one dose of study drug, and whose PK data were evaluable.

Primary outcome: Cmax: Maximum Observed Plasma Concentration for TAK-438F

Measure	Pilot BE Study 1: TAK-438 OD 20 mg n = 24	Pilot BE Study 1: TAK-438 20 mg n = 24	Pilot BE Study 2: TAK-438 OD 20 mg n = 24	Pilot BE Study 2: TAK-438 20 mg n = 24
Value	22.62 (7.8152)	24.26 (8.0676)	21.85 (7.7286)	23.70 (8.5998)

Pilot BE Study 1: TAK-438 OD 20 mg vs Pilot BE Study 1: TAK-438 20 mg: LS-Means Difference: -0.0698 (90% CI -0.1404 to 0.0008)
Pilot BE Study 2: TAK-438 OD 20 mg vs Pilot BE Study 2: TAK-438 20 mg: LS-Means Difference: -0.0811 (90% CI -0.1658 to 0.0036)

Population analysed: The PK analysis set was defined as all participants who received at least one dose of study drug, and whose PK data were evaluable.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAEs) are adverse events (AE) that started after the first dose of study drug until Day 3 in Period 2 (up to Day 13). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pilot BE Study 1: TAK-438 OD 20 mg	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Pilot BE Study 1: TAK-438 20 mg	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Pilot BE Study 2: TAK-438 OD 20 mg	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Pilot BE Study 2: TAK-438 20 mg	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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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.

Study Director study director

Takeda

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 TAK-438 OD and TAK-438 in people with Japanese Healthy Adult Male, run by Takeda 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 6 inclusion and 18 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 7 Apr 2020. 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 24 Mar 2020). 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?

AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Plasma Concentration for TAK-438 Free Base (TAK-438F) (time frame: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 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 NCT03808493.

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 7 Apr 2020.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (6 listed)

Key exclusion criteria (18 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Plasma Concentration for TAK-438 Free Base (TAK-438F)

Primary outcome: Cmax: Maximum Observed Plasma Concentration for TAK-438F

Adverse events

Research links

Related trials for Japanese Healthy Adult Male

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A Study to Evaluate the Effect of Food on the Bioavailability of AJ201, and Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants

Referral and contact

Questions about this trial

Participant flow

Primary outcome: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Plasma Concentration for TAK-438 Free Base (TAK-438F)

Primary outcome: Cmax: Maximum Observed Plasma Concentration for TAK-438F

Adverse events