Healthy VolunteersPhase 1NCT03434977

A Phase 1 Food Effect Study of Azilsartan (TAK-536) Pediatric Formulation

A Phase 1 study testing TAK-536 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.

Trial summary

The purpose of this study is to assess the PK of TAK-536 and effect of food on the PK following single oral administration of TAK-536 pediatric formulation in Japanese healthy adult male participants. Read more about this study

Who is it for?: Ages 20 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: TAK-536
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteJapan
Study dates: 14 Feb 2018to 11 Mar 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 35 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 Japanese healthy adult male.
The participant ages 20 to 35 years inclusive at the time of informed consent.
The participant weighs at least 50.0 kilogram (kg), and has a Body Mass Index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m^2), inclusive, at Screening.

Who cannot join

The participant has suspected hypotension with associated physical findings, such as dizziness postural, facial pallor, or cold sweats based on evaluation/physical examination at Screening, on the day before the study drug administration (Day -1) in Period 1, or up to the study drug administration in Period 1.
The participant has received any study drug within 16 weeks (112 days) prior to the study drug administration in Period 1.
The participant has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic agent.
The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
The participant has a hypersensitivity to any component of the formulation of TAK-536 or any ARB.
The participant has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening.

Show all 18Show fewer

The participant has a history of drug abuse (defined as any illicit drug use) or a history of 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, dietary products or food products during the specified time periods.
The participant has any current or recent (within 6 months prior to the start of the study drug administration in Period 1) gastrointestinal diseases that would be expected to influence the absorption of drugs (that is, 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 of Period 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 the 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 the study drug administration in Period 1.
The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of the study drug administration in Period 1.
The participant has an abnormal (clinically significant) ECG at Screening or prior to the study drug administration in Period 1.
The participant has abnormal laboratory values that suggest a clinically significant underlying disease, or participant with the following laboratory abnormalities at Screening or prior to the study drug administration in Period 1: Alanine Aminotransferase (ALT) and/or Aspartate Transaminase (AST) greater than (>) 1.5× 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

Fukuoka Mirai Hospital
Fukuoka

Other trials in Japan

About this study

Official title: A Randomized, Open-Label, Cross-over Phase 1 Study to Evaluate the Food Effect of Single Oral Dose of TAK-536 Pediatric Formulation in Healthy Adult Male Subjects

Read the detailed description

The drug being tested in this study is called TAK-536. TAK-536 is being tested in Japanese healthy adult male participants. This study will look at the PK and effect of food on the PK following single oral administration of TAK-536 pediatric formulation.

The study will enroll 12 healthy participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups and will receive a single oral dose of 10 mg of TAK-536 pediatric formulation with 200 mL of water according to the following treatments in each period during the study.

Treatment Group A: single oral administration in the morning under fasted condition (Period 1), followed by single oral administration after breakfast (Period 2)
Treatment Group B: single oral administration after breakfast (Period 1), followed by in the morning under fasted condition (Period 2)

This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately one month. Participants will make five visits to the clinic and be hospitalized for eight days in total.

Conditions: Healthy Volunteers
Being tested: TAK-536
Keywords: Drug Therapy

What participants receive

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

TAK-536Drug
TAK-536 granule formulation

Study groups in NCT03434977
Study group	Role	What they receive
TAK-536 10 mg (fasted) + TAK-536 10 mg (fed)	Experimental	TAK-536 10 milligram (mg) granule formulation (pediatric formulation), once daily on Day 1 of Period 1 (6 days) in the morning under fasted condition, followed by wash-out (6 days), followed by TAK-536 10 mg granule formulation (pediatric formulation), once daily on Day 1 of Period 2 (6 days) after starting breakfast. Receives: Drug: TAK-536
TAK-536 10 mg (fed) + TAK-536 10 mg (fasted)	Experimental	TAK-536 10 mg granule formulation (pediatric formulation), once daily on Day 1 of Period 1 (6 days) after starting breakfast, followed by wash-out (6 days), followed by TAK-536 10 mg granule formulation (pediatric formulation), once daily on Day 1 of Period 2 (6 days) in the morning under fasted condition. Receives: Drug: TAK-536

What is being measured

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

Cmax: Maximum Observed Plasma Concentration for TAK-536
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
T1/2z: Terminal Disposition Phase Half-life for TAK-536
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
MRT∞, ev: Mean Residence Time From Time 0 to Infinity for TAK-536
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
λz: Terminal Disposition Phase Rate Constant for TAK-536
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
CL/F: Apparent Clearance for TAK-536
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Vz/F: Apparent Volume of Distribution for TAK-536
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

Secondary outcomes (5)

Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
Measured: Baseline up to Day 18 (End of Period 2)
Number of Participants With TEAE Related to Vital Sign
Measured: Baseline up to Day 18 (End of Period 2)
Number of Participants With TEAE Related to Body Weight
Measured: Baseline up to Day 18 (End of Period 2)
Number of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased)
Measured: Baseline up to Day 18 (End of Period 2)
Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs)
Measured: Baseline up to Day 18 (End of Period 2)

Timeline

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

14 Feb 201811 Mar 2018

First posted15 Feb 2018
Study start14 Feb 2018
Primary completion11 Mar 2018
Study completion11 Mar 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03434977
Sponsor's protocol ID: Azilsartan-1005
Other IDs: U1111-1206-5973, JapicCTI-183856
Status last verified: Jun 2019
First submitted: 8 Feb 2018
Last updated: 10 Jun 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 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Cross-over Phase 1 Study to Evaluate the Food Effect of Single Oral Dose of TAK-536 Pediatric Formulation in Healthy Adult Male Subjects
ClinicalTrials.gov ID: NCT03434977
Acronym / sponsor ID: Azilsartan-1005
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 14 Feb 2018 (actual)
Primary completion: 11 Mar 2018 (actual)
Study completion: 11 Mar 2018 (actual)
First posted: 15 Feb 2018 (actual)
Results: Posted 7 Jun 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

Treatment Group A: single oral administration in the morning under fasted condition (Period 1), followed by single oral administration after breakfast (Period 2)
Treatment Group B: single oral administration after breakfast (Period 1), followed by in the morning under fasted condition (Period 2)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TAK-536 10 mg (fasted) + TAK-536 10 mg (fed)	Experimental	Drug: TAK-536TAK-536 10 milligram (mg) granule formulation (pediatric formulation), once daily on Day 1 of Period 1 (6 days) in the morning under fasted condition, followed by wash-out (6 days), followed by TAK-536 10 mg granule formulation (pediatric formulation), once daily on Day 1 of Period 2 (6 days) after starting breakfast.
TAK-536 10 mg (fed) + TAK-536 10 mg (fasted)	Experimental	Drug: TAK-536TAK-536 10 mg granule formulation (pediatric formulation), once daily on Day 1 of Period 1 (6 days) after starting breakfast, followed by wash-out (6 days), followed by TAK-536 10 mg granule formulation (pediatric formulation), once daily on Day 1 of Period 2 (6 days) in the morning under fasted condition.

Who may qualify

Ages: 20 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 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 Japanese healthy adult male.
The participant ages 20 to 35 years inclusive at the time of informed consent.
The participant weighs at least 50.0 kilogram (kg), and has a Body Mass Index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m^2), inclusive, at Screening.

Key exclusion criteria (18 listed)

The participant has suspected hypotension with associated physical findings, such as dizziness postural, facial pallor, or cold sweats based on evaluation/physical examination at Screening, on the day before the study drug administration (Day -1) in Period 1, or up to the study drug administration in Period 1.
The participant has received any study drug within 16 weeks (112 days) prior to the study drug administration in Period 1.
The participant has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic agent.
The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
The participant has a hypersensitivity to any component of the formulation of TAK-536 or any ARB.

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-536TAK-536 granule formulation	Drug	TAK-536 10 mg (fasted) + TAK-536 10 mg (fed), TAK-536 10 mg (fed) + TAK-536 10 mg (fasted)

Primary outcome

Cmax: Maximum Observed Plasma Concentration for TAK-536
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
T1/2z: Terminal Disposition Phase Half-life for TAK-536
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
MRT∞, ev: Mean Residence Time From Time 0 to Infinity for TAK-536
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
λz: Terminal Disposition Phase Rate Constant for TAK-536
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
CL/F: Apparent Clearance for TAK-536
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Vz/F: Apparent Volume of Distribution for TAK-536
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose

5 secondary outcomes

Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: Baseline up to Day 18 (End of Period 2)
Number of Participants With TEAE Related to Vital Sign
Time frame: Baseline up to Day 18 (End of Period 2)
Number of Participants With TEAE Related to Body Weight
Time frame: Baseline up to Day 18 (End of Period 2)
Number of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased)
Time frame: Baseline up to Day 18 (End of Period 2)
Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs)
Time frame: Baseline up to Day 18 (End of Period 2)

Results and safety

Results posted to the registry on 7 Jun 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
TAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules Fed	6	6
TAK-536 10 mg Granules Fed + TAK-536 10 mg Granules Fasted	6	6

Primary outcome: Cmax: Maximum Observed Plasma Concentration for TAK-536

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

Measure	TAK-536 10 mg Granules Fasted n = 11	TAK-536 10 mg Granules Fed n = 11
Value	652.6 (78.03)	609.4 (103.92)

TAK-536 10 mg Granules Fasted vs TAK-536 10 mg Granules Fed: Ratio: 0.937 (90% CI 0.890 to 0.986)

Population analysed: The pharmacokinetic (PK) analysis set was defined as all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.

Primary outcome: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536

Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose. Median (Full Range). Unit: hours

Measure	TAK-536 10 mg Granules Fasted n = 11	TAK-536 10 mg Granules Fed n = 11
Value	2.000 (1.00 to 4.00)	3.000 (2.00 to 4.00)

TAK-536 10 mg Granules Fasted vs TAK-536 10 mg Granules Fed: LS-Means Difference: 0.9083 (90% CI 0.1821 to 1.6345)

Population analysed: The PK analysis set was defined as all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.

Primary outcome: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536

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

Measure	TAK-536 10 mg Granules Fasted n = 11	TAK-536 10 mg Granules Fed n = 11
Value	5275.3 (1044.49)	5220.7 (881.13)

TAK-536 10 mg Granules Fasted vs TAK-536 10 mg Granules Fed: Ratio: 0.998 (90% CI 0.943 to 1.056)

Primary outcome: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536

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

Measure	TAK-536 10 mg Granules Fasted n = 11	TAK-536 10 mg Granules Fed n = 11
Value	5440.1 (1109.74)	5377.8 (918.96)

TAK-536 10 mg Granules Fasted vs TAK-536 10 mg Granules Fed: Ratio: 0.997 (90% CI 0.942 to 1.056)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: TEAEs are adverse events that started after the first dose of study drug until the follow up examination on Day 6 in Period 2 (Day 18). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-536 10 mg Granules Fasted	0 of 11 (0%)	0 of 11 (0%)	0 of 11
TAK-536 10 mg Granules Fed	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 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-536 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 5 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 10 Jun 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 7 Jun 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?

Cmax: Maximum Observed Plasma Concentration for TAK-536 (time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose). The study lists 10 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 NCT03434977.

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 10 Jun 2019.