Healthy Volunteers
Conditions
Keywords
Drug Therapy
Brief 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.
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.
Interventions
DRUGTAK-536
TAK-536 granule formulation
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vz/F: Apparent Volume of Distribution for TAK-536 | 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 | 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 | 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 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose |
| λz: Terminal Disposition Phase Rate Constant for TAK-536 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose |
| CL/F: Apparent Clearance for TAK-536 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose |
| Cmax: Maximum Observed Plasma Concentration for TAK-536 | 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 | 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 | 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 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With TEAE Related to Vital Sign | Baseline up to Day 18 (End of Period 2) |
| Number of Participants With TEAE Related to Body Weight | Baseline up to Day 18 (End of Period 2) |
| Number of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased) | Baseline up to Day 18 (End of Period 2) |
| Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs) | Baseline up to Day 18 (End of Period 2) |
| Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | Baseline up to Day 18 (End of Period 2) |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in Japan from 14 February 2018 to 11 March 2018.
Pre-assignment details
Healthy male participants were enrolled in 1 of the 2 treatment sequences of this 2-period cross-over study to receive pediatric formulation of TAK-536 10 milligram (mg) granules under fasted or fed condition.
Participants by arm
| Arm | Count |
|---|---|
| TAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules Fed TAK-536 10 mg, granules (pediatric formulation), orally, under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, under fed condition, once on Day 1 of Period 2. | 6 |
| TAK-536 10 mg Granules Fed + TAK-536 10 mg Granules Fasted TAK-536 10 mg, granules (pediatric formulation), orally, under fed condition, once on Day 1 of Period 1, followed by a washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, under fasted condition, once on Day 1 of Period 2. | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout Period (at Least 6 Days) | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Total | TAK-536 10 mg Granules Fed + TAK-536 10 mg Granules Fasted | TAK-536 10 mg Granules Fasted + TAK-536 10 mg Granules Fed |
|---|---|---|---|
| Age, Continuous | 23.5 years STANDARD_DEVIATION 4.27 | 24.3 years STANDARD_DEVIATION 5.57 | 22.7 years STANDARD_DEVIATION 2.73 |
| Alcohol Classification Drank a few times per month | 10 Participants | 5 Participants | 5 Participants |
| Alcohol Classification Never drank | 2 Participants | 1 Participants | 1 Participants |
| Body Mass Index (BMI) | 21.47 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.133 | 21.23 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.392 | 21.72 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.036 |
| Caffeine Classification Had caffeine consumption | 3 Participants | 0 Participants | 3 Participants |
| Caffeine Classification Had no caffeine consumption | 9 Participants | 6 Participants | 3 Participants |
| Height | 174.4 centimeter (cm) STANDARD_DEVIATION 6.39 | 173.2 centimeter (cm) STANDARD_DEVIATION 5.71 | 175.7 centimeter (cm) STANDARD_DEVIATION 7.31 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Japan | 12 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 6 Participants | 6 Participants |
| Smoking Classification Current smoker | 6 Participants | 5 Participants | 1 Participants |
| Smoking Classification Former smoker | 1 Participants | 0 Participants | 1 Participants |
| Smoking Classification Never smoked | 5 Participants | 1 Participants | 4 Participants |
| Weight | 65.45 kilogram (kg) STANDARD_DEVIATION 8.566 | 64.02 kilogram (kg) STANDARD_DEVIATION 11.129 | 66.88 kilogram (kg) STANDARD_DEVIATION 5.712 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 12 |
| other Total, other adverse events | 0 / 11 | 1 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-536 10 mg Granules Fasted | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536 | 5440.1 h*ng/mL | Standard Deviation 1109.74 |
| TAK-536 10 mg Granules Fed | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536 | 5377.8 h*ng/mL | Standard Deviation 918.96 |
Comparison: The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters AUC∞ as dependent variable, and treatment condition, group, and period as independent variables.90% CI: [0.942, 1.056]
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-536 10 mg Granules Fasted | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536 | 5275.3 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 1044.49 |
| TAK-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-536 | 5220.7 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 881.13 |
Comparison: The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters AUClast as dependent variable, and treatment condition, group, and period as independent variables.90% CI: [0.943, 1.056]
Primary
CL/F: Apparent Clearance for TAK-536
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-536 10 mg Granules Fasted | CL/F: Apparent Clearance for TAK-536 | 1.912 Liter per hour (L/h) | Standard Deviation 0.40241 |
| TAK-536 10 mg Granules Fed | CL/F: Apparent Clearance for TAK-536 | 1.909 Liter per hour (L/h) | Standard Deviation 0.3198 |
Comparison: The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters CL/F as dependent variable, and treatment condition, group, and period as independent variables.90% CI: [0.947, 1.062]
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-536 10 mg Granules Fasted | Cmax: Maximum Observed Plasma Concentration for TAK-536 | 652.6 nanogram per milliliter (ng/mL) | Standard Deviation 78.03 |
| TAK-536 10 mg Granules Fed | Cmax: Maximum Observed Plasma Concentration for TAK-536 | 609.4 nanogram per milliliter (ng/mL) | Standard Deviation 103.92 |
Comparison: The shown data were ratio of fed conditions divided by fasted conditions, taking anti-logs of the least square (LS) means difference (fed-fasted) or confidence interval (CI). The difference in LS means between treatment conditions (fed-fasted) and two-sided 90% CI were provided using a crossover analysis of variance (ANOVA) model. ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and treatment condition, group, and period as independent variables.90% CI: [0.89, 0.986]
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-536 10 mg Granules Fasted | MRT∞, ev: Mean Residence Time From Time 0 to Infinity for TAK-536 | 11.02 hours | Standard Deviation 1.3931 |
| TAK-536 10 mg Granules Fed | MRT∞, ev: Mean Residence Time From Time 0 to Infinity for TAK-536 | 11.40 hours | Standard Deviation 0.90089 |
Comparison: The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters MRT∞, ev as dependent variable, and treatment condition, group, and period as independent variables.90% CI: [0.996, 1.081]
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-536 10 mg Granules Fasted | MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536 | 9.419 hours | Standard Deviation 1.0233 |
| TAK-536 10 mg Granules Fed | MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536 | 9.836 hours | Standard Deviation 0.61518 |
Comparison: The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters MRTlast, ev as dependent variable, and treatment condition, group, and period as independent variables.90% CI: [1.006, 1.091]
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-536 10 mg Granules Fasted | T1/2z: Terminal Disposition Phase Half-life for TAK-536 | 11.11 hours | Standard Deviation 0.9005 |
| TAK-536 10 mg Granules Fed | T1/2z: Terminal Disposition Phase Half-life for TAK-536 | 10.96 hours | Standard Deviation 0.85065 |
Comparison: The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters T1/2z as dependent variable, and treatment condition, group, and period as independent variables.90% CI: [0.932, 1.041]
Primary
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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAK-536 10 mg Granules Fasted | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 | 2.000 hours |
| TAK-536 10 mg Granules Fed | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 | 3.000 hours |
Comparison: The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (non-natural log) PK parameters tmax as dependent variable, and treatment condition, group, and period as independent variables.90% CI: [0.1821, 1.6345]
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-536 10 mg Granules Fasted | Vz/F: Apparent Volume of Distribution for TAK-536 | 30.35 liter | Standard Deviation 5.5177 |
| TAK-536 10 mg Granules Fed | Vz/F: Apparent Volume of Distribution for TAK-536 | 30.14 liter | Standard Deviation 5.2637 |
Comparison: The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Vz/F as dependent variable, and treatment condition, group, and period as independent variables.90% CI: [0.916, 1.068]
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-536 10 mg Granules Fasted | λz: Terminal Disposition Phase Rate Constant for TAK-536 | 0.06285 1 per hour (1/h) | Standard Deviation 0.0048845 |
| TAK-536 10 mg Granules Fed | λz: Terminal Disposition Phase Rate Constant for TAK-536 | 0.06355 1 per hour (1/h) | Standard Deviation 0.0047738 |
Comparison: The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters λz as dependent variable, and treatment condition, group, and period as independent variables.90% CI: [0.959, 1.071]
Secondary
Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: Baseline up to Day 18 (End of Period 2)
Population: The safety analysis set was defined as all participants who received at least one dose of the study drug. Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to adverse event (AE) before the start of Period 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAK-536 10 mg Granules Fasted | Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | 0 Participants |
| TAK-536 10 mg Granules Fed | Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | 1 Participants |
Secondary
Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs)
Time frame: Baseline up to Day 18 (End of Period 2)
Population: The safety analysis set was defined as all participants who received at least one dose of the study drug. Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to AE before the start of Period 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAK-536 10 mg Granules Fasted | Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs) | 0 Participants |
| TAK-536 10 mg Granules Fed | Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs) | 0 Participants |
Secondary
Number of Participants With TEAE Related to Body Weight
Time frame: Baseline up to Day 18 (End of Period 2)
Population: The safety analysis set was defined as all participants who received at least one dose of the study drug. Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to AE before the start of Period 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAK-536 10 mg Granules Fasted | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| TAK-536 10 mg Granules Fed | Number of Participants With TEAE Related to Body Weight | 0 Participants |
Secondary
Number of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased)
Time frame: Baseline up to Day 18 (End of Period 2)
Population: The safety analysis set was defined as all participants who received at least one dose of the study drug. Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to AE before the start of Period 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAK-536 10 mg Granules Fasted | Number of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased) | 0 Participants |
| TAK-536 10 mg Granules Fed | Number of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased) | 1 Participants |
Secondary
Number of Participants With TEAE Related to Vital Sign
Time frame: Baseline up to Day 18 (End of Period 2)
Population: The safety analysis set was defined as all participants who received at least one dose of the study drug. Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to AE before the start of Period 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAK-536 10 mg Granules Fasted | Number of Participants With TEAE Related to Vital Sign | 0 Participants |
| TAK-536 10 mg Granules Fed | Number of Participants With TEAE Related to Vital Sign | 0 Participants |