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CompletedNCT03434977Updated Jun 10, 2019Results posted

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

A Phase 1 interventional study of TAK-536 in Healthy Volunteers, sponsored by Takeda. Completed at 1 site in Japan. Open to male participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-10.

Sponsored by Takeda · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Drug Therapy
03

In context

Lead sponsor

Takeda is the lead sponsor of 1,025 studies on the registry; 92 are open to participants now.

Of its 177 completed or terminated interventional studies of FDA-regulated products, 153 (86%) have results posted.

Browse Takeda studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
  2. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
  3. The participant is a Japanese healthy adult male.
  4. The participant ages 20 to 35 years inclusive at the time of informed consent.
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. The participant has received any study drug within 16 weeks (112 days) prior to the study drug administration in Period 1.
  3. The participant has received TAK-536 or TAK-491 in a previous clinical study or as a therapeutic agent.
  4. 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.
  5. The participant has a hypersensitivity to any component of the formulation of TAK-536 or any ARB.
  6. The participant has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening.
  7. 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.
  8. The participant has taken any excluded medication, supplements, dietary products or food products during the specified time periods.
  9. 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).
  10. 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.
  11. 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.
  12. The participant has poor peripheral venous access.
  13. 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.
  14. 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.
  15. The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of the study drug administration in Period 1.
  16. The participant has an abnormal (clinically significant) ECG at Screening or prior to the study drug administration in Period 1.
  17. 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).
  18. 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    TAK-536 10 mg (fasted) + TAK-536 10 mg (fed)

    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.

    Drug: TAK-536

  • Experimental
    TAK-536 10 mg (fed) + TAK-536 10 mg (fasted)

    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.

    Drug: TAK-536

Interventions

  • DrugTAK-536

    TAK-536 granule formulation

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. CL/F: Apparent Clearance for TAK-536

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

  10. 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

Secondary outcomes

  1. Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)

    Time frame: Baseline up to Day 18 (End of Period 2)

  2. Number of Participants With TEAE Related to Vital Sign

    Time frame: Baseline up to Day 18 (End of Period 2)

  3. Number of Participants With TEAE Related to Body Weight

    Time frame: Baseline up to Day 18 (End of Period 2)

  4. Number of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased)

    Time frame: Baseline up to Day 18 (End of Period 2)

  5. Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs)

    Time frame: Baseline up to Day 18 (End of Period 2)

07

Results

Posted Jun 7, 2019

Participant flow

Participants took part in the study at 1 investigative site in Japan from 14 February 2018 to 11 March 2018.

Intervention Period 1 (6 Days)
Participant flow — Intervention Period 1 (6 Days)
MilestoneTAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules FedTAK-536 10 mg Granules Fed + TAK-536 10 mg Granules Fasted
Started66
Completed66
Not completed00
Washout Period (at Least 6 Days)
Participant flow — Washout Period (at Least 6 Days)
MilestoneTAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules FedTAK-536 10 mg Granules Fed + TAK-536 10 mg Granules Fasted
Started66
Completed65
Not completed01
Withdrew: Adverse event01
Intervention Period 2 (6 Days)
Participant flow — Intervention Period 2 (6 Days)
MilestoneTAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules FedTAK-536 10 mg Granules Fed + TAK-536 10 mg Granules Fasted
Started65
Completed65
Not completed00

Outcome measures

PrimaryCmax: Maximum Observed Plasma Concentration for TAK-536
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Mean · nanogram per milliliter (ng/mL)
Cmax: Maximum Observed Plasma Concentration for TAK-536
nanogram per milliliter (ng/mL)TAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
Cmax: Maximum Observed Plasma Concentration for TAK-536652.6 ± 78.03609.4 ± 103.92
Statistical analysis
  • TAK-536 10 mg Granules Fasted vs TAK-536 10 mg Granules Fed · Ratio: 0.937 · 90% CI 0.890 to 0.986
PrimaryTmax: 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
Reported as:
Median · hours
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536
hoursTAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-5362.000 (1.00 to 4.00)3.000 (2.00 to 4.00)
Statistical analysis
  • 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
PrimaryAUClast: 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
Reported as:
Mean · hour*nanogram per milliliter (h*ng/mL)
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536
hour*nanogram per milliliter (h*ng/mL)TAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-5365275.3 ± 1044.495220.7 ± 881.13
Statistical analysis
  • TAK-536 10 mg Granules Fasted vs TAK-536 10 mg Granules Fed · Ratio: 0.998 · 90% CI 0.943 to 1.056
PrimaryAUC∞: 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
Reported as:
Mean · h*ng/mL
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536
h*ng/mLTAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-5365440.1 ± 1109.745377.8 ± 918.96
Statistical analysis
  • TAK-536 10 mg Granules Fasted vs TAK-536 10 mg Granules Fed · Ratio: 0.997 · 90% CI 0.942 to 1.056
PrimaryT1/2z: 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
Reported as:
Mean · hours
T1/2z: Terminal Disposition Phase Half-life for TAK-536
hoursTAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
T1/2z: Terminal Disposition Phase Half-life for TAK-53611.11 ± 0.9005010.96 ± 0.85065
Statistical analysis
  • TAK-536 10 mg Granules Fasted vs TAK-536 10 mg Granules Fed · Ratio: 0.985 · 90% CI 0.932 to 1.041
PrimaryMRTlast, 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
Reported as:
Mean · hours
MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536
hoursTAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration for TAK-5369.419 ± 1.02339.836 ± 0.61518
Statistical analysis
  • TAK-536 10 mg Granules Fasted vs TAK-536 10 mg Granules Fed · Ratio: 1.047 · 90% CI 1.006 to 1.091
PrimaryMRT∞, 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
Reported as:
Mean · hours
MRT∞, ev: Mean Residence Time From Time 0 to Infinity for TAK-536
hoursTAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
MRT∞, ev: Mean Residence Time From Time 0 to Infinity for TAK-53611.02 ± 1.393111.40 ± 0.90089
Statistical analysis
  • TAK-536 10 mg Granules Fasted vs TAK-536 10 mg Granules Fed · Ratio: 1.037 · 90% CI 0.996 to 1.081
Primaryλz: 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
Reported as:
Mean · 1 per hour (1/h)
λz: Terminal Disposition Phase Rate Constant for TAK-536
1 per hour (1/h)TAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
λz: Terminal Disposition Phase Rate Constant for TAK-5360.06285 ± 0.00488450.06355 ± 0.0047738
Statistical analysis
  • TAK-536 10 mg Granules Fasted vs TAK-536 10 mg Granules Fed · Ratio: 1.014 · 90% CI 0.959 to 1.071
PrimaryCL/F: Apparent Clearance for TAK-536
Time frame:
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Reported as:
Mean · Liter per hour (L/h)
CL/F: Apparent Clearance for TAK-536
Liter per hour (L/h)TAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
CL/F: Apparent Clearance for TAK-5361.912 ± 0.402411.909 ± 0.31980
Statistical analysis
  • TAK-536 10 mg Granules Fasted vs TAK-536 10 mg Granules Fed · Ratio: 1.003 · 90% CI 0.947 to 1.062
PrimaryVz/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
Reported as:
Mean · liter
Vz/F: Apparent Volume of Distribution for TAK-536
literTAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
Vz/F: Apparent Volume of Distribution for TAK-53630.35 ± 5.517730.14 ± 5.2637
Statistical analysis
  • TAK-536 10 mg Granules Fasted vs TAK-536 10 mg Granules Fed · Ratio: 0.989 · 90% CI 0.916 to 1.068
SecondaryNumber of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
Time frame:
Baseline up to Day 18 (End of Period 2)
Reported as:
Count of participants · Participants
Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
ParticipantsTAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)01
SecondaryNumber of Participants With TEAE Related to Vital Sign
Time frame:
Baseline up to Day 18 (End of Period 2)
Reported as:
Count of participants · Participants
Number of Participants With TEAE Related to Vital Sign
ParticipantsTAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
Number of Participants With TEAE Related to Vital Sign00
SecondaryNumber of Participants With TEAE Related to Body Weight
Time frame:
Baseline up to Day 18 (End of Period 2)
Reported as:
Count of participants · Participants
Number of Participants With TEAE Related to Body Weight
ParticipantsTAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
Number of Participants With TEAE Related to Body Weight00
SecondaryNumber of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased)
Time frame:
Baseline up to Day 18 (End of Period 2)
Reported as:
Count of participants · Participants
Number of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased)
ParticipantsTAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
Number of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased)01
SecondaryNumber of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs)
Time frame:
Baseline up to Day 18 (End of Period 2)
Reported as:
Count of participants · Participants
Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs)
ParticipantsTAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs)00

Adverse events

Collected over 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). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TAK-536 10 mg Granules Fasted0/11 (0%)0/11 (0%)0/11 (0%)
TAK-536 10 mg Granules Fed0/12 (0%)0/12 (0%)1/12 (8.3%)
Most frequent other events
Most frequent other events
EventTAK-536 10 mg Granules FastedTAK-536 10 mg Granules Fed
Eosinophil count increasedInvestigations0/111/12

Baseline characteristics

The safety analysis set was defined as all participants who received at least one dose of the study drug.

Age, Continuous
Age, Continuous(years)TAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules FedTAK-536 10 mg Granules Fed + TAK-536 10 mg Granules FastedTotal
Mean22.7 ± 2.7324.3 ± 5.5723.5 ± 4.27
Sex: Female, Male
Sex: Female, Male(Participants)TAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules FedTAK-536 10 mg Granules Fed + TAK-536 10 mg Granules FastedTotal
Female000
Male6612
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)TAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules FedTAK-536 10 mg Granules Fed + TAK-536 10 mg Granules FastedTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(Participants)TAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules FedTAK-536 10 mg Granules Fed + TAK-536 10 mg Granules FastedTotal
Japan6612
Height
Height(centimeter (cm))TAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules FedTAK-536 10 mg Granules Fed + TAK-536 10 mg Granules FastedTotal
Mean175.7 ± 7.31173.2 ± 5.71174.4 ± 6.39
Weight
Weight(kilogram (kg))TAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules FedTAK-536 10 mg Granules Fed + TAK-536 10 mg Granules FastedTotal
Mean66.88 ± 5.71264.02 ± 11.12965.45 ± 8.566
Body Mass Index (BMI)
Body Mass Index (BMI)(kilogram per square meter (kg/m^2))TAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules FedTAK-536 10 mg Granules Fed + TAK-536 10 mg Granules FastedTotal
Mean21.72 ± 2.03621.23 ± 2.39221.47 ± 2.133
Smoking Classification
Smoking Classification(Participants)TAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules FedTAK-536 10 mg Granules Fed + TAK-536 10 mg Granules FastedTotal
Never smoked415
Current smoker156
Former smoker101

2 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Fukuoka Mirai Hospital
    Fukuoka, Japan
09

References and documents

Study documents

  • Study protocol · Dec 8, 2017
  • Statistical analysis plan · Jan 10, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03434977
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Feb 15, 2018
Start date
Feb 14, 2018
Primary completion
Mar 11, 2018
Completion
Mar 11, 2018
Results posted
Jun 7, 2019
Last update
Jun 10, 2019

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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