Healthy VolunteersPhase 1NCT03456960

A Study to Evaluate the Bioequivalence (BE) and the Food Effect of TAK-438ASA Tablet

A Phase 1 study testing TAK-438ASA, TAK-438 and Aspirin in people with Healthy Volunteers, 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 purposes of this study are to evaluate BE between a single-dose of TAK-438ASA tablet versus a single-dose combination of TAK-438 tablet 10 milligram (mg) and aspirin enteric-coated tablet 100 mg in Japanese healthy adult men (Study 1), and to evaluate the effects of food on the pharmacokinetics of TAK-438ASA… 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: Healthy Volunteers
What is being tested?: TAK-438ASA, TAK-438 and Aspirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 276 participants
Where: 1 siteJapan
Study dates: 8 Mar 2018to 12 Oct 2018
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, participants are capable of understanding the procedures required for the study and complying with its requirements.
Participants sign and date an informed consent form by themselves prior to the initiation of any study procedures.
Japanese healthy men aged greater than or equal to (>=) 20 and less than or equal to (=<) 60, inclusive, at the time of consent.
Body weight >=50 kilogram (kg) as well as body mass index (BMI) >=18.5 kilogram per meter square (kg/m^2) and =<25.0 kg/m^2 at screening test.

Who cannot join

Participants who received study drug within 16 weeks (112 days) prior to the start of study treatment in Period 1.
Participants who received TAK-438 or aspirin in a previous study.
Staffs at the study site and their family, or participants who depend on the study-related staffs at the study site (example, husband and wife, parents, children, brothers and sisters), or participants who may be constrained to consent to the study.
Participants with uncontrolled and clinically significant neurological, cardiovascular, lung, hepatic, renal, metabolic, gastrointestinal, urinary or endocrine disease, or other abnormalities (except for diseases investigated) that might affect the study participation or impact the results of the study.
Participants with a previous or current history of aspirin asthma (asthmatic attack induced by non-steroidal anti-inflammatory drugs, etc.).
Participants with hypersensitivity for components of TAK-438 tablet or aspirin enteric-coated tablet, or salicylic acid-based products.

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Positive result in urinary test for illegal drug abuse at screening.
Participants who have a history of illegal drug abuse or alcoholism within the past 2 years prior to the screening visit, or who are not willing to refrain from alcohol consumption and drug use during the study period.
Participants who ingested a medicine, a supplement or food forbidden to be used in combination during the specified time period.
Participants with a current history or recent episodes (within the past 6 months) of gastrointestinal diseases (malabsorption, gastroesophageal reflux, peptic ulcer disease, erosive oesophagitis), frequent (at least once per week) heartburn or surgical intervention that might affect drug absorption.
Participants with a history of cancer, except for basal cell carcinoma in remission for >=5 years prior to Day 1.
Positive results at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, or serological test for syphilis.
Participants who have difficulties in blood draw from peripheral veins.
Participants who had >=200 milliliter (mL) of whole blood drawn within 4 weeks (28 days) prior to the start of study treatment in Period 1 or who had >=400 mL of whole blood drawn within 12 weeks (84 days) prior to the start of study treatment in Period 1.
Participants who had a total of >=800 mL of whole blood drawn within 52 weeks (364 days) prior to the start of study treatment in Period 1.
Participants who had blood components drawn within 2 weeks (14 days) prior to the start of study treatment in Period 1.
Clinically significant abnormalities in electrocardiogram at screening or admission (Day -1).
Participants with abnormal laboratory parameters suggestive of clinically significant underlying diseases or who have abnormal values in the following measures at screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) over the upper limit of normal.
Participants who are unlikely to comply with the protocol or deemed ineligible due to other reasons by the principal investigator or other investigators.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Fukuoka Mirai Hospital
Fukuoka

Other trials in Japan

About this study

Official title: A Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Bioequivalence of Single Oral Dose of TAK-438ASA Tablet and Single Oral Dose of TAK-438 Tablet Plus Aspirin Enteric-Coated Tablet (Study 1) and the Food Effect of Single Oral Dose of TAK-438ASA Tablet (Study 2) in Healthy Adult Male Subjects

Read the detailed description

The drug under investigation in this study is called TAK-438ASA. TAK-438ASA is being tested in Japanese healthy adult men. This study consists of two studies to evaluate bioequivalence (Study 1) and the effects of food (Study 2). Study 1 (split into a Pilot phase and a Pivotal phase) will look at bioequivalence between a single-dose of TAK-438ASA tablet versus a single-dose combination of TAK-438 tablet 10 mg and aspirin enteric-coated tablet 100 mg. Study 2 will look at the effects of food on the pharmacokinetics of TAK-438ASA tablet.

The study will enroll up to 440 participants in total (Study 1 + 2). For Study 1, 12 participants per group (24 participants in total) will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups for the pilot study to estimate the sample size of Pivotal study. After pilot study, 202 participants as a maximum per group (404 participants in total) will be randomly assigned to one of the two treatment groups:

TAK-438ASA tablet (Period 1) + TAK-438 10 mg tablet and Aspirin 100 mg tablet (Period 2)
TAK-438 10 mg tablet and Aspirin 100 mg tablet (Period 1) + TAK-438ASA tablet (Period 2)

For Study 2, 6 participants per group (12 participants in total) will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

TAK-438ASA tablet (Fasted condition) + TAK-438ASA tablet (Fed condition)
TAK-438ASA tablet (Fed condition) + TAK-438ASA tablet (Fasted condition) This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 18 days. Participants will make two visits to the clinic and be hospitalized for eight days in total.

Conditions: Healthy Volunteers
Being tested: TAK-438ASA, TAK-438, Aspirin
Keywords: Drug Therapy

What participants receive

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

TAK-438ASADrug
TAK-438ASA tablet.
TAK-438Drug
TAK-438 tablet.
AspirinDrug
Aspirin enteric-coated tablet.

Study groups in NCT03456960
Study group	Role	What they receive
Pilot phase of Study 1,TAK-438ASA + TAK-438 and Aspirin	Experimental	One TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 1 in the Pilot phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 2 in the Pilot phase of Study 1 (Day 16). Receives: Drug: TAK-438ASA; Drug: TAK-438; Drug: Aspirin
Pilot phase of Study 1,TAK-438 and Aspirin + TAK-438ASA	Experimental	One TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 1 in the Pilot phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by, one TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 2 in the Pilot phase of Study 1 (Day 16). Receives: Drug: TAK-438ASA; Drug: TAK-438; Drug: Aspirin
Pivotal phase of Study 1, TAK-438ASA + TAK-438 and Aspirin	Experimental	One TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 1 in the Pivotal phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 2 in the Pivotal phase of Study 1 (Day 16). Receives: Drug: TAK-438ASA; Drug: TAK-438; Drug: Aspirin
Pivotal phase of Study 1, TAK-438 and Aspirin + TAK-438ASA	Experimental	One TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 1 in the Pivotal phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 2 in the Pivotal phase of Study 1 (Day 16). Receives: Drug: TAK-438ASA; Drug: TAK-438; Drug: Aspirin
Study 2,TAK-438ASA (Fasted + Fed condition)	Experimental	One TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 1 in Study 2 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438ASA tablet, orally 30 minutes after breakfast, on Day 1 of Period 2 in Study 2 (Day 16). Receives: Drug: TAK-438ASA
Study 2,TAK-438ASA (Fed + Fasted condition)	Experimental	One TAK-438ASA tablet, orally 30 minutes after breakfast, on Day 1 of Period 1 in Study 2 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 2 in Study 2 (Day 16). Receives: Drug: TAK-438ASA

What is being measured

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

Study 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Free Base of TAK-438 (TAK-438F)
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 1, Cmax: Maximum Observed Plasma Concentration for TAK-438F
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Unchanged Aspirin
Measured: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Study 1, Cmax: Maximum Observed Plasma Concentration for Unchanged Aspirin
Measured: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose

Secondary outcomes (26)

Study 1, 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) post-dose
Study 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 1, MRT (Infinity,ev): Mean Residence Time From Time 0 to Infinity for TAK-438F
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 1, Lambda (z): Terminal Disposition Phase Rate Constant for TAK-438F
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Unchanged Aspirin
Measured: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Study 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Unchanged Aspirin
Measured: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Study 1, MRT (Infinity,ev): Mean Residence Time From Time 0 to Infinity for Unchanged Aspirin
Measured: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Study 1, Lambda (z): Terminal Disposition Phase Rate Constant for Unchanged Aspirin
Measured: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Study 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites (M) (M-I, M-II, M-III and M-IV-Sul)
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to Time 48 Hours Over the Dosing Interval for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, Cmax: Maximum Observed Plasma Concentration for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, T1/2z: Terminal Disposition Phase Half-life for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Over the Dosing Interval for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, Cmax: Maximum Observed Plasma Concentration for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, T1/2z: Terminal Disposition Phase Half-life for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, Ae(0-48): Amount of Drug Excreted in Urine From Time 0 to 48 Hours for TAK-438F and Its Metabolites (M-I, M-II, M-III, and M-IV-Sul)
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, Fe(0-48): Fraction of Administered Dose Excreted Into Urine From Time 0 to Time 48 Hours for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, CLR: Renal Clearance for TAK-438F and Its Metabolites (M-I, M-II, M-III, and M-IV-Sul)
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, Fe(0-24): Fraction of Administered Dose Excreted Into Urine From Time 0 to Time 24 Hours for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, CLR: Renal Clearance for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

Timeline

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

8 Mar 201812 Oct 2018

First posted7 Mar 2018
Study start8 Mar 2018
Primary completion10 Oct 2018
Study completion12 Oct 2018

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 VolunteersStudies 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: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03456960
Sponsor's protocol ID: TAK-438ASA-1001
Other IDs: U1111-1208-7631, JapicCTI-183885
Status last verified: Nov 2019
First submitted: 1 Mar 2018
Last updated: 19 Nov 2019
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 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Bioequivalence of Single Oral Dose of TAK-438ASA Tablet and Single Oral Dose of TAK-438 Tablet Plus Aspirin Enteric-Coated Tablet (Study 1) and the Food Effect of Single Oral Dose of TAK-438ASA Tablet (Study 2) in Healthy Adult Male Subjects
ClinicalTrials.gov ID: NCT03456960
Acronym / sponsor ID: TAK-438ASA-1001
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 8 Mar 2018 (actual)
Primary completion: 10 Oct 2018 (actual)
Study completion: 12 Oct 2018 (actual)
First posted: 7 Mar 2018 (actual)
Results: Posted 4 Nov 2019

Clinical summary

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

Detailed description

TAK-438ASA tablet (Period 1) + TAK-438 10 mg tablet and Aspirin 100 mg tablet (Period 2)
TAK-438 10 mg tablet and Aspirin 100 mg tablet (Period 1) + TAK-438ASA tablet (Period 2)

For Study 2, 6 participants per group (12 participants in total) will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

TAK-438ASA tablet (Fasted condition) + TAK-438ASA tablet (Fed condition)
TAK-438ASA tablet (Fed condition) + TAK-438ASA tablet (Fasted condition) This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 18 days. Participants will make two visits to the clinic and be hospitalized for eight days in total.

Study design

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

Arm	Type	Receives
Pilot phase of Study 1,TAK-438ASA + TAK-438 and Aspirin	Experimental	Drug: TAK-438ASA, Drug: TAK-438, Drug: AspirinOne TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 1 in the Pilot phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 2 in the Pilot phase of Study 1 (Day 16).
Pilot phase of Study 1,TAK-438 and Aspirin + TAK-438ASA	Experimental	Drug: TAK-438ASA, Drug: TAK-438, Drug: AspirinOne TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 1 in the Pilot phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by, one TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 2 in the Pilot phase of Study 1 (Day 16).
Pivotal phase of Study 1, TAK-438ASA + TAK-438 and Aspirin	Experimental	Drug: TAK-438ASA, Drug: TAK-438, Drug: AspirinOne TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 1 in the Pivotal phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 2 in the Pivotal phase of Study 1 (Day 16).
Pivotal phase of Study 1, TAK-438 and Aspirin + TAK-438ASA	Experimental	Drug: TAK-438ASA, Drug: TAK-438, Drug: AspirinOne TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 1 in the Pivotal phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 2 in the Pivotal phase of Study 1 (Day 16).
Study 2,TAK-438ASA (Fasted + Fed condition)	Experimental	Drug: TAK-438ASAOne TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 1 in Study 2 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438ASA tablet, orally 30 minutes after breakfast, on Day 1 of Period 2 in Study 2 (Day 16).
Study 2,TAK-438ASA (Fed + Fasted condition)	Experimental	Drug: TAK-438ASAOne TAK-438ASA tablet, orally 30 minutes after breakfast, on Day 1 of Period 1 in Study 2 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 2 in Study 2 (Day 16).

Who may qualify

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

Key inclusion criteria (4 listed)

In the opinion of the investigator or sub-investigator, participants are capable of understanding the procedures required for the study and complying with its requirements.
Participants sign and date an informed consent form by themselves prior to the initiation of any study procedures.
Japanese healthy men aged greater than or equal to (>=) 20 and less than or equal to (=<) 60, inclusive, at the time of consent.
Body weight >=50 kilogram (kg) as well as body mass index (BMI) >=18.5 kilogram per meter square (kg/m^2) and =<25.0 kg/m^2 at screening test.

Key exclusion criteria (19 listed)

Participants who received study drug within 16 weeks (112 days) prior to the start of study treatment in Period 1.
Participants who received TAK-438 or aspirin in a previous study.
Staffs at the study site and their family, or participants who depend on the study-related staffs at the study site (example, husband and wife, parents, children, brothers and sisters), or participants who may be constrained to consent to the study.
Participants with uncontrolled and clinically significant neurological, cardiovascular, lung, hepatic, renal, metabolic, gastrointestinal, urinary or endocrine disease, or other abnormalities (except for diseases investigated) that might affect the study participation or impact the results of the study.
Participants with a previous or current history of aspirin asthma (asthmatic attack induced by non-steroidal anti-inflammatory drugs, etc.).

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-438ASATAK-438ASA tablet.	Drug	Pilot phase of Study 1,TAK-438 and Aspirin + TAK-438ASA, Pilot phase of Study 1,TAK-438ASA + TAK-438 and Aspirin, Pivotal phase of Study 1, TAK-438 and Aspirin + TAK-438ASA, Pivotal phase of Study 1, TAK-438ASA + TAK-438 and Aspirin, Study 2,TAK-438ASA (Fasted + Fed condition), Study 2,TAK-438ASA (Fed + Fasted condition)
TAK-438TAK-438 tablet.	Drug	Pilot phase of Study 1,TAK-438 and Aspirin + TAK-438ASA, Pilot phase of Study 1,TAK-438ASA + TAK-438 and Aspirin, Pivotal phase of Study 1, TAK-438 and Aspirin + TAK-438ASA, Pivotal phase of Study 1, TAK-438ASA + TAK-438 and Aspirin
AspirinAspirin enteric-coated tablet.	Drug	Pilot phase of Study 1,TAK-438 and Aspirin + TAK-438ASA, Pilot phase of Study 1,TAK-438ASA + TAK-438 and Aspirin, Pivotal phase of Study 1, TAK-438 and Aspirin + TAK-438ASA, Pivotal phase of Study 1, TAK-438ASA + TAK-438 and Aspirin

Primary outcome

Study 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Free Base of TAK-438 (TAK-438F)
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 1, Cmax: Maximum Observed Plasma Concentration for TAK-438F
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Unchanged Aspirin
Time frame: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Study 1, Cmax: Maximum Observed Plasma Concentration for Unchanged Aspirin
Time frame: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose

26 secondary outcomes

Study 1, 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) post-dose
Study 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 1, MRT (Infinity,ev): Mean Residence Time From Time 0 to Infinity for TAK-438F
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 1, Lambda (z): Terminal Disposition Phase Rate Constant for TAK-438F
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Unchanged Aspirin
Time frame: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Study 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Unchanged Aspirin
Time frame: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Study 1, MRT (Infinity,ev): Mean Residence Time From Time 0 to Infinity for Unchanged Aspirin
Time frame: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Study 1, Lambda (z): Terminal Disposition Phase Rate Constant for Unchanged Aspirin
Time frame: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose
Study 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites (M) (M-I, M-II, M-III and M-IV-Sul)
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to Time 48 Hours Over the Dosing Interval for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, Cmax: Maximum Observed Plasma Concentration for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, T1/2z: Terminal Disposition Phase Half-life for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Over the Dosing Interval for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, Cmax: Maximum Observed Plasma Concentration for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, T1/2z: Terminal Disposition Phase Half-life for Unchanged Aspirin and Its Metabolite (Salicylic Acid)
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, Ae(0-48): Amount of Drug Excreted in Urine From Time 0 to 48 Hours for TAK-438F and Its Metabolites (M-I, M-II, M-III, and M-IV-Sul)
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, Fe(0-48): Fraction of Administered Dose Excreted Into Urine From Time 0 to Time 48 Hours for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, CLR: Renal Clearance for TAK-438F and Its Metabolites (M-I, M-II, M-III, and M-IV-Sul)
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Study 2, Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, Fe(0-24): Fraction of Administered Dose Excreted Into Urine From Time 0 to Time 24 Hours for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Study 2, CLR: Renal Clearance for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

Results and safety

Results posted to the registry on 4 Nov 2019, 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 Study 1, Sequence A: TAK-438ASA + TAK-438 and Aspirin	12	12
Pilot Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASA	12	12
Pivotal Study 1, Sequence A: TAK-438ASA + TAK-438 and Aspirin	120	120
Pivotal Study 1, Sequence B: TAK-438 and Aspirin + TAK-438ASA	120	120
Study 2, Sequence C: TAK-438ASA (Fasted + Fed Condition)	6	6
Study 2, Sequence D: TAK-438ASA (Fed + Fasted Condition)	6	6

Primary outcome: Study 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Free Base of TAK-438 (TAK-438F)

Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose. Geometric mean (Standard Deviation). Unit: hour*nanogram per milliliter (h*ng/mL)

Measure	Pilot Study 1: TAK-438ASA n = 23	Pilot Study 1: TAK-438 and Aspirin n = 23	Pivotal Study 1: TAK-438ASA n = 0	Pivotal Study 1: TAK-438 and Aspirin n = 0
Value	92.46 (32.128)	91.95 (31.431)	–	–

Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin: LSM Difference: 0.0059 (90% CI -0.0340 to 0.0458)

Population analysed: The pharmacokinetic (PK) analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable. Samples were not collected for Pivotal Study 1 because sufficient results were available for TAK-438F from the Pilot Study 1.

Primary outcome: Study 1, Cmax: Maximum Observed Plasma Concentration for TAK-438F

Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose. Geometric mean (Standard Deviation). Unit: nanogram per milliliter (ng/mL)

Measure	Pilot Study 1: TAK-438ASA n = 23	Pilot Study 1: TAK-438 and Aspirin n = 23	Pivotal Study 1: TAK-438ASA n = 0	Pivotal Study 1: TAK-438 and Aspirin n = 0
Value	13.87 (5.0945)	13.22 (5.0778)	–	–

Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin: LSM Difference: 0.0508 (90% CI -0.0079 to 0.1096)

Population analysed: The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable. Samples were not collected for Pivotal Study 1 because sufficient results were available for TAK-438F from the Pilot Study 1.

Primary outcome: Study 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Unchanged Aspirin

Time frame: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose. Geometric mean (Standard Deviation). Unit: h*ng/mL

Measure	Pilot Study 1: TAK-438ASA n = 23	Pilot Study 1: TAK-438 and Aspirin n = 23	Pivotal Study 1: TAK-438ASA n = 233	Pivotal Study 1: TAK-438 and Aspirin n = 233
Value	873.5 (220.94)	831.9 (350.69)	912.3 (327.58)	832.7 (323.46)

Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin: LSM Difference: 0.0546 (90% CI -0.0941 to 0.2034)
Pivotal Study 1: TAK-438ASA vs Pivotal Study 1: TAK-438 and Aspirin: LSM Difference: 0.0912 (90% CI 0.0399 to 0.1424)

Population analysed: The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.

Primary outcome: Study 1, Cmax: Maximum Observed Plasma Concentration for Unchanged Aspirin

Time frame: Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose. Geometric mean (Standard Deviation). Unit: ng/mL

Measure	Pilot Study 1: TAK-438ASA n = 23	Pilot Study 1: TAK-438 and Aspirin n = 23	Pivotal Study 1: TAK-438ASA n = 233	Pivotal Study 1: TAK-438 and Aspirin n = 233
Value	647.6 (326.77)	597.5 (507.90)	701.8 (349.18)	558.0 (404.26)

Pilot Study 1: TAK-438ASA vs Pilot Study 1: TAK-438 and Aspirin: LSM Difference: 0.0916 (90% CI -0.1330 to 0.3162)
Pivotal Study 1: TAK-438ASA vs Pivotal Study 1: TAK-438 and Aspirin: LSM Difference: 0.2293 (90% CI 0.1519 to 0.3068)

Population analysed: The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.

26 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events (AE) that started after the first dose of study drug and no more than 2 days after the last dose of study drug in Period 2 (Day 18). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pilot Study 1: TAK-438ASA	0 of 24 (0%)	1 of 24 (4.2%)	0 of 24
Pilot Study 1: TAK-438 and Aspirin	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Pivotal Study 1: TAK-438ASA	0 of 237 (0%)	8 of 237 (3.4%)	0 of 237
Pivotal Study 1: TAK-438 and Aspirin	0 of 239 (0%)	3 of 239 (1.3%)	0 of 239
Study 2: TAK-438ASA Fasted	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Study 2: TAK-438ASA Fed	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
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-438ASA, TAK-438 and Aspirin in people with Healthy Volunteers, 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 4 inclusion and 19 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 19 Nov 2019. 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 4 Nov 2019). 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?

Study 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Free Base of TAK-438 (TAK-438F) (time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose). The study lists 4 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 NCT03456960.

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 19 Nov 2019.