Healthy Participants
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to determine the pharmacokinetics (PK) of TAK-438 in healthy adult Chinese participants after both single and multiple dose administration.
Detailed description
The drug being tested in this study is called TAK-438. TAK-438 is being tested in healthy participants in order to evaluate the PK of single and multiple oral dose. The study will enroll approximately 36 healthy participants. Participants will be assigned to one of the three treatment groups: * TAK-438 10 mg tablet once daily * TAK-438 20 mg tablet once daily * TAK-438 20 mg tablet twice daily All participants will be asked to take TAK-438 tablet at the same time on Day 1 and Days 3-9. This single-centre trial will be conducted in China. The overall time to participate in this study is 18 days. Participants will remain confined to the clinic from Day 1 up to Day 11 and will be followed-up by telephone or visit on Day 18.
Interventions
DRUGTAK-438
TAK-438 tablets.
Sponsors
Takeda
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is a healthy adult male or female Chinese participant. 2. Is aged 18 to 45 years, inclusive, at the time of signing the informed consent form. 3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 19 and 26 kilogram per square meter (kg/m\^2), inclusive at Screening (Check-In Day -1). 4. Is willing to abstain from caffeine and alcohol from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18. 5. Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18. 6. Is willing to provide a sample for pharmacogenetic analysis (for cytochrome \[CYP2C19\] genotyping).
Exclusion criteria
1. Has uncontrolled, clinically significant cardiovascular disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results. 2. Is lactose intolerant or has a known hypersensitivity to any component of the formulation of TAK-438. 3. Has poor peripheral venous access. 4. Has donated or lost 400 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day 1; or participant has donated or lost more than 200 mL or more of his or her blood in the last 28 days. 5. Has a history of symptomatic gastroesophageal reflux disease (GERD), Erosive Esophagitis, duodenal ulcer (DU), gastric ulcer (GU), dyspepsia, Barrett's Esophagus, or Zollinger-Ellison (ZE) syndrome or has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose |
| Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose |
| 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 on Day 1 | Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose |
| AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose |
| T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose |
| Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose |
| Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose |
| AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose |
| Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose |
| Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose |
| CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose |
| Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose |
| Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose |
| CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose |
Countries
China
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in China from 19 April 2017 to 17 August 2017.
Pre-assignment details
Healthy Chinese participants were enrolled in this study to receive treatment in one of the 3 treatment groups: TAK-438 10 milligram (mg) once daily or TAK-438 20 mg once daily or TAK-438-20 mg twice daily.
Participants by arm
| Arm | Count |
|---|---|
| TAK-438 10 mg Once Daily TAK-438 10 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment. | 12 |
| TAK-438 20 mg Once Daily TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment. | 11 |
| TAK-438 20 mg Twice Daily TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner. | 10 |
| Total | 33 |
Baseline characteristics
| Characteristic | TAK-438 20 mg Once Daily | TAK-438 20 mg Twice Daily | Total | TAK-438 10 mg Once Daily |
|---|---|---|---|---|
| Age, Continuous | 23.9 years STANDARD_DEVIATION 3.99 | 27.2 years STANDARD_DEVIATION 4.83 | 25.4 years STANDARD_DEVIATION 4.04 | 25.2 years STANDARD_DEVIATION 2.95 |
| Alcohol consumption Never drank | 11 Participants | 10 Participants | 33 Participants | 12 Participants |
| Body mass index (BMI) | 22.89 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.711 | 22.88 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.11 | 22.79 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.918 | 22.63 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.086 |
| Caffeine consumption Had no caffeine consumption | 11 Participants | 10 Participants | 33 Participants | 12 Participants |
| Cytochrome P450 2C19 (CYP2C19) Genotype *1/*1 | 4 Participants | 4 Participants | 13 Participants | 5 Participants |
| Cytochrome P450 2C19 (CYP2C19) Genotype *1/*2 | 6 Participants | 5 Participants | 15 Participants | 4 Participants |
| Cytochrome P450 2C19 (CYP2C19) Genotype *1/*3 | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Cytochrome P450 2C19 (CYP2C19) Genotype *2/*2 | 1 Participants | 0 Participants | 2 Participants | 1 Participants |
| Cytochrome P450 2C19 (CYP2C19) Genotype *2/*3 | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Cytochrome P450 2C19 (CYP2C19) Genotype *3/*3 | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 169.59 centimeter (cm) STANDARD_DEVIATION 7.672 | 164.31 centimeter (cm) STANDARD_DEVIATION 9.377 | 166.81 centimeter (cm) STANDARD_DEVIATION 8.498 | 166.35 centimeter (cm) STANDARD_DEVIATION 8.426 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 10 Participants | 33 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 11 Participants | 10 Participants | 33 Participants | 12 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 15 Participants | 6 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 18 Participants | 6 Participants |
| Smoking classification Never smoked | 11 Participants | 10 Participants | 33 Participants | 12 Participants |
| Weight | 66.05 kilogram (kg) STANDARD_DEVIATION 8.501 | 61.66 kilogram (kg) STANDARD_DEVIATION 6.449 | 63.47 kilogram (kg) STANDARD_DEVIATION 7.597 | 62.63 kilogram (kg) STANDARD_DEVIATION 7.601 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 4 / 12 | 6 / 11 | 4 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 | 0 / 10 |
Outcome results
Primary
Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Population: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-438 10 mg Once Daily | Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 0.000 microgram (mcg) | Standard Deviation 0 |
| TAK-438 10 mg Once Daily | Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 0.000 microgram (mcg) | Standard Deviation 0 |
| TAK-438 10 mg Once Daily | Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 448.5 microgram (mcg) | Standard Deviation 159.06 |
| TAK-438 10 mg Once Daily | Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 176.6 microgram (mcg) | Standard Deviation 79.813 |
| TAK-438 10 mg Once Daily | Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 205.4 microgram (mcg) | Standard Deviation 61.587 |
| TAK-438 20 mg Once Daily | Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 0.000 microgram (mcg) | Standard Deviation 0 |
| TAK-438 20 mg Once Daily | Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 890.3 microgram (mcg) | Standard Deviation 243.24 |
| TAK-438 20 mg Once Daily | Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 253.1 microgram (mcg) | Standard Deviation 118.69 |
| TAK-438 20 mg Once Daily | Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 0.000 microgram (mcg) | Standard Deviation 0 |
| TAK-438 20 mg Once Daily | Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 422.1 microgram (mcg) | Standard Deviation 143.24 |
| TAK-438 20 mg Twice Daily | Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 387.1 microgram (mcg) | Standard Deviation 142.06 |
| TAK-438 20 mg Twice Daily | Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 0.5120 microgram (mcg) | Standard Deviation 1.6191 |
| TAK-438 20 mg Twice Daily | Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 1478 microgram (mcg) | Standard Deviation 405.32 |
| TAK-438 20 mg Twice Daily | Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 0.000 microgram (mcg) | Standard Deviation 0 |
| TAK-438 20 mg Twice Daily | Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 211.2 microgram (mcg) | Standard Deviation 124.21 |
Primary
Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
Population: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-438 10 mg Once Daily | Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 0.000 mcg | Standard Deviation 0 |
| TAK-438 10 mg Once Daily | Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 0.000 mcg | Standard Deviation 0 |
| TAK-438 10 mg Once Daily | Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 437.7 mcg | Standard Deviation 121.93 |
| TAK-438 10 mg Once Daily | Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 224.3 mcg | Standard Deviation 79.531 |
| TAK-438 10 mg Once Daily | Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 205.2 mcg | Standard Deviation 52.172 |
| TAK-438 20 mg Once Daily | Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 0.000 mcg | Standard Deviation 0 |
| TAK-438 20 mg Once Daily | Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 859.9 mcg | Standard Deviation 155.66 |
| TAK-438 20 mg Once Daily | Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 354.1 mcg | Standard Deviation 165.88 |
| TAK-438 20 mg Once Daily | Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 0.000 mcg | Standard Deviation 0 |
| TAK-438 20 mg Once Daily | Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 390.7 mcg | Standard Deviation 99.477 |
| TAK-438 20 mg Twice Daily | Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 446.4 mcg | Standard Deviation 139.39 |
| TAK-438 20 mg Twice Daily | Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 0.000 mcg | Standard Deviation 0 |
| TAK-438 20 mg Twice Daily | Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 1327 mcg | Standard Deviation 274.04 |
| TAK-438 20 mg Twice Daily | Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 0.000 mcg | Standard Deviation 0 |
| TAK-438 20 mg Twice Daily | Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 340.9 mcg | Standard Deviation 181.71 |
Primary
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Population: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-438 10 mg Once Daily | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 92.83 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 34.769 |
| TAK-438 10 mg Once Daily | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 52.97 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 22.843 |
| TAK-438 10 mg Once Daily | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 84.38 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 29.197 |
| TAK-438 10 mg Once Daily | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 305.7 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 88.227 |
| TAK-438 10 mg Once Daily | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 132.5 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 44.602 |
| TAK-438 20 mg Once Daily | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 106.3 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 74.306 |
| TAK-438 20 mg Once Daily | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 188.1 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 43.066 |
| TAK-438 20 mg Once Daily | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 617.2 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 213.56 |
| TAK-438 20 mg Once Daily | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 178.7 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 64.779 |
| TAK-438 20 mg Once Daily | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 307.5 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 89.884 |
| TAK-438 20 mg Twice Daily | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 240.8 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 82.555 |
| TAK-438 20 mg Twice Daily | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 193.7 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 56.808 |
| TAK-438 20 mg Twice Daily | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 226.8 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 67.128 |
| TAK-438 20 mg Twice Daily | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 117.8 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 41.17 |
| TAK-438 20 mg Twice Daily | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 578.7 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 144.15 |
Primary
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Population: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-438 10 mg Once Daily | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 87.98 h*ng/mL | Standard Deviation 31.136 |
| TAK-438 10 mg Once Daily | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 31.77 h*ng/mL | Standard Deviation 18.646 |
| TAK-438 10 mg Once Daily | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 74.91 h*ng/mL | Standard Deviation 24.835 |
| TAK-438 10 mg Once Daily | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 251.4 h*ng/mL | Standard Deviation 77.758 |
| TAK-438 10 mg Once Daily | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 127.1 h*ng/mL | Standard Deviation 43.648 |
| TAK-438 20 mg Once Daily | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 79.07 h*ng/mL | Standard Deviation 56.206 |
| TAK-438 20 mg Once Daily | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 168.6 h*ng/mL | Standard Deviation 37.455 |
| TAK-438 20 mg Once Daily | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 528.8 h*ng/mL | Standard Deviation 182.62 |
| TAK-438 20 mg Once Daily | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 169.2 h*ng/mL | Standard Deviation 59.474 |
| TAK-438 20 mg Once Daily | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 296.0 h*ng/mL | Standard Deviation 86.359 |
| TAK-438 20 mg Twice Daily | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 192.8 h*ng/mL | Standard Deviation 57.176 |
| TAK-438 20 mg Twice Daily | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 149.1 h*ng/mL | Standard Deviation 36.714 |
| TAK-438 20 mg Twice Daily | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 154.8 h*ng/mL | Standard Deviation 38.92 |
| TAK-438 20 mg Twice Daily | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 41.55 h*ng/mL | Standard Deviation 19.189 |
| TAK-438 20 mg Twice Daily | AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 344.1 h*ng/mL | Standard Deviation 91.089 |
Primary
AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
Population: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations. PK analysis population where data at specified time points were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-438 10 mg Once Daily | AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 95.94 h*ng/mL | Standard Deviation 29.719 |
| TAK-438 10 mg Once Daily | AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 46.31 h*ng/mL | Standard Deviation 24.298 |
| TAK-438 10 mg Once Daily | AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 93.90 h*ng/mL | Standard Deviation 28.053 |
| TAK-438 10 mg Once Daily | AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 285.5 h*ng/mL | Standard Deviation 77.884 |
| TAK-438 10 mg Once Daily | AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 117.1 h*ng/mL | Standard Deviation 37.489 |
| TAK-438 20 mg Once Daily | AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 105.5 h*ng/mL | Standard Deviation 51.688 |
| TAK-438 20 mg Once Daily | AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 212.7 h*ng/mL | Standard Deviation 57.214 |
| TAK-438 20 mg Once Daily | AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 581.1 h*ng/mL | Standard Deviation 198.14 |
| TAK-438 20 mg Once Daily | AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 194.6 h*ng/mL | Standard Deviation 53.749 |
| TAK-438 20 mg Once Daily | AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 256.1 h*ng/mL | Standard Deviation 62.786 |
| TAK-438 20 mg Twice Daily | AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 225.7 h*ng/mL | Standard Deviation 52.675 |
| TAK-438 20 mg Twice Daily | AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 222.6 h*ng/mL | Standard Deviation 49.67 |
| TAK-438 20 mg Twice Daily | AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 273.4 h*ng/mL | Standard Deviation 71.83 |
| TAK-438 20 mg Twice Daily | AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 100.4 h*ng/mL | Standard Deviation 27.966 |
| TAK-438 20 mg Twice Daily | AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 435.3 h*ng/mL | Standard Deviation 92.064 |
Primary
CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Population: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations. PK analysis population where data at specified time points were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-438 10 mg Once Daily | CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 5.443 liter per hour (L/h) | Standard Deviation 1.0398 |
| TAK-438 10 mg Once Daily | CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 0.000 liter per hour (L/h) | Standard Deviation 0 |
| TAK-438 10 mg Once Daily | CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 0.000 liter per hour (L/h) | Standard Deviation 0 |
| TAK-438 10 mg Once Daily | CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 1.748 liter per hour (L/h) | Standard Deviation 0.65948 |
| TAK-438 10 mg Once Daily | CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 0.6235 liter per hour (L/h) | Standard Deviation 0.16437 |
| TAK-438 20 mg Once Daily | CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 0.000 liter per hour (L/h) | Standard Deviation 0 |
| TAK-438 20 mg Once Daily | CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 4.922 liter per hour (L/h) | Standard Deviation 1.4362 |
| TAK-438 20 mg Once Daily | CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 0.4465 liter per hour (L/h) | Standard Deviation 0.24193 |
| TAK-438 20 mg Once Daily | CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 0.000 liter per hour (L/h) | Standard Deviation 0 |
| TAK-438 20 mg Once Daily | CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 1.527 liter per hour (L/h) | Standard Deviation 0.77444 |
| TAK-438 20 mg Twice Daily | CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 0.3753 liter per hour (L/h) | Standard Deviation 0.19679 |
| TAK-438 20 mg Twice Daily | CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 0.001820 liter per hour (L/h) | Standard Deviation 0.0057553 |
| TAK-438 20 mg Twice Daily | CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 6.733 liter per hour (L/h) | Standard Deviation 1.3109 |
| TAK-438 20 mg Twice Daily | CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 1.707 liter per hour (L/h) | Standard Deviation 0.47416 |
| TAK-438 20 mg Twice Daily | CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 0.000 liter per hour (L/h) | Standard Deviation 0 |
Primary
CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
Population: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations. PK analysis population where data at specified time points were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-438 10 mg Once Daily | CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 0.000 L/h | Standard Deviation 0 |
| TAK-438 10 mg Once Daily | CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 1.931 L/h | Standard Deviation 0.79907 |
| TAK-438 10 mg Once Daily | CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 0.000 L/h | Standard Deviation 0 |
| TAK-438 10 mg Once Daily | CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 0.8126 L/h | Standard Deviation 0.26393 |
| TAK-438 10 mg Once Daily | CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 4.848 L/h | Standard Deviation 1.2372 |
| TAK-438 20 mg Once Daily | CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 0.000 L/h | Standard Deviation 0 |
| TAK-438 20 mg Once Daily | CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 4.251 L/h | Standard Deviation 1.1565 |
| TAK-438 20 mg Once Daily | CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 0.6207 L/h | Standard Deviation 0.22632 |
| TAK-438 20 mg Once Daily | CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 1.614 L/h | Standard Deviation 0.58643 |
| TAK-438 20 mg Once Daily | CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 0.000 L/h | Standard Deviation 0 |
| TAK-438 20 mg Twice Daily | CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 2.067 L/h | Standard Deviation 0.70761 |
| TAK-438 20 mg Twice Daily | CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 4.977 L/h | Standard Deviation 0.71952 |
| TAK-438 20 mg Twice Daily | CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 0.000 L/h | Standard Deviation 0 |
| TAK-438 20 mg Twice Daily | CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 0.000 L/h | Standard Deviation 0 |
| TAK-438 20 mg Twice Daily | CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 0.7943 L/h | Standard Deviation 0.39001 |
Primary
Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Population: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-438 10 mg Once Daily | Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 15.42 nanogram per milliliter (ng/mL) | Standard Deviation 3.7788 |
| TAK-438 10 mg Once Daily | Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 2.840 nanogram per milliliter (ng/mL) | Standard Deviation 1.0442 |
| TAK-438 10 mg Once Daily | Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 9.148 nanogram per milliliter (ng/mL) | Standard Deviation 2.9972 |
| TAK-438 10 mg Once Daily | Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 38.32 nanogram per milliliter (ng/mL) | Standard Deviation 8.6143 |
| TAK-438 10 mg Once Daily | Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 28.29 nanogram per milliliter (ng/mL) | Standard Deviation 5.0563 |
| TAK-438 20 mg Once Daily | Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 5.155 nanogram per milliliter (ng/mL) | Standard Deviation 2.7868 |
| TAK-438 20 mg Once Daily | Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 18.18 nanogram per milliliter (ng/mL) | Standard Deviation 4.4973 |
| TAK-438 20 mg Once Daily | Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 67.95 nanogram per milliliter (ng/mL) | Standard Deviation 23.388 |
| TAK-438 20 mg Once Daily | Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 25.63 nanogram per milliliter (ng/mL) | Standard Deviation 7.865 |
| TAK-438 20 mg Once Daily | Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 60.67 nanogram per milliliter (ng/mL) | Standard Deviation 16.499 |
| TAK-438 20 mg Twice Daily | Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 42.28 nanogram per milliliter (ng/mL) | Standard Deviation 9.1174 |
| TAK-438 20 mg Twice Daily | Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 25.67 nanogram per milliliter (ng/mL) | Standard Deviation 5.9219 |
| TAK-438 20 mg Twice Daily | Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 25.23 nanogram per milliliter (ng/mL) | Standard Deviation 10.017 |
| TAK-438 20 mg Twice Daily | Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 4.879 nanogram per milliliter (ng/mL) | Standard Deviation 2.2426 |
| TAK-438 20 mg Twice Daily | Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 59.02 nanogram per milliliter (ng/mL) | Standard Deviation 18.443 |
Primary
Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
Population: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-438 10 mg Once Daily | Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 16.62 ng/mL | Standard Deviation 4.1919 |
| TAK-438 10 mg Once Daily | Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 3.558 ng/mL | Standard Deviation 1.4983 |
| TAK-438 10 mg Once Daily | Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 11.01 ng/mL | Standard Deviation 3.4863 |
| TAK-438 10 mg Once Daily | Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 43.39 ng/mL | Standard Deviation 9.6528 |
| TAK-438 10 mg Once Daily | Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 25.33 ng/mL | Standard Deviation 3.6619 |
| TAK-438 20 mg Once Daily | Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 6.554 ng/mL | Standard Deviation 2.6078 |
| TAK-438 20 mg Once Daily | Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 23.43 ng/mL | Standard Deviation 6.1433 |
| TAK-438 20 mg Once Daily | Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 79.85 ng/mL | Standard Deviation 22.119 |
| TAK-438 20 mg Once Daily | Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 30.15 ng/mL | Standard Deviation 7.3228 |
| TAK-438 20 mg Once Daily | Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 54.08 ng/mL | Standard Deviation 13.927 |
| TAK-438 20 mg Twice Daily | Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 39.74 ng/mL | Standard Deviation 7.1405 |
| TAK-438 20 mg Twice Daily | Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 33.01 ng/mL | Standard Deviation 6.1638 |
| TAK-438 20 mg Twice Daily | Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 37.88 ng/mL | Standard Deviation 10.91 |
| TAK-438 20 mg Twice Daily | Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 9.174 ng/mL | Standard Deviation 2.8376 |
| TAK-438 20 mg Twice Daily | Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 59.55 ng/mL | Standard Deviation 15.512 |
Primary
Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Population: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-438 10 mg Once Daily | Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 0.000 percentage of drug | Standard Deviation 0 |
| TAK-438 10 mg Once Daily | Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 0.000 percentage of drug | Standard Deviation 0 |
| TAK-438 10 mg Once Daily | Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 4.485 percentage of drug | Standard Deviation 1.5906 |
| TAK-438 10 mg Once Daily | Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 1.760 percentage of drug | Standard Deviation 0.79678 |
| TAK-438 10 mg Once Daily | Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 1.609 percentage of drug | Standard Deviation 0.48258 |
| TAK-438 20 mg Once Daily | Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 0.000 percentage of drug | Standard Deviation 0 |
| TAK-438 20 mg Once Daily | Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 4.448 percentage of drug | Standard Deviation 1.2093 |
| TAK-438 20 mg Once Daily | Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 1.262 percentage of drug | Standard Deviation 0.59122 |
| TAK-438 20 mg Once Daily | Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 0.000 percentage of drug | Standard Deviation 0 |
| TAK-438 20 mg Once Daily | Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 1.650 percentage of drug | Standard Deviation 0.56108 |
| TAK-438 20 mg Twice Daily | Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 1.513 percentage of drug | Standard Deviation 0.55536 |
| TAK-438 20 mg Twice Daily | Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 0.002460 percentage of drug | Standard Deviation 0.0077792 |
| TAK-438 20 mg Twice Daily | Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 7.399 percentage of drug | Standard Deviation 2.0335 |
| TAK-438 20 mg Twice Daily | Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 0.000 percentage of drug | Standard Deviation 0 |
| TAK-438 20 mg Twice Daily | Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 1.053 percentage of drug | Standard Deviation 0.61992 |
Primary
Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
Population: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-438 10 mg Once Daily | Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 0.000 percentage of drug | Standard Deviation 0 |
| TAK-438 10 mg Once Daily | Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 0.000 percentage of drug | Standard Deviation 0 |
| TAK-438 10 mg Once Daily | Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 4.377 percentage of drug | Standard Deviation 1.2193 |
| TAK-438 10 mg Once Daily | Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 2.236 percentage of drug | Standard Deviation 0.79323 |
| TAK-438 10 mg Once Daily | Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 1.605 percentage of drug | Standard Deviation 0.40853 |
| TAK-438 20 mg Once Daily | Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 0.000 percentage of drug | Standard Deviation 0 |
| TAK-438 20 mg Once Daily | Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 4.299 percentage of drug | Standard Deviation 0.77678 |
| TAK-438 20 mg Once Daily | Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 1.765 percentage of drug | Standard Deviation 0.82755 |
| TAK-438 20 mg Once Daily | Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 0.000 percentage of drug | Standard Deviation 0 |
| TAK-438 20 mg Once Daily | Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 1.528 percentage of drug | Standard Deviation 0.38946 |
| TAK-438 20 mg Twice Daily | Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 1.748 percentage of drug | Standard Deviation 0.54499 |
| TAK-438 20 mg Twice Daily | Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 0.000 percentage of drug | Standard Deviation 0 |
| TAK-438 20 mg Twice Daily | Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 6.634 percentage of drug | Standard Deviation 1.3737 |
| TAK-438 20 mg Twice Daily | Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 0.000 percentage of drug | Standard Deviation 0 |
| TAK-438 20 mg Twice Daily | Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 1.700 percentage of drug | Standard Deviation 0.90664 |
Primary
T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Population: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations. PK analysis population where data at specified time points were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-438 10 mg Once Daily | T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 6.695 hour | Standard Deviation 1.3786 |
| TAK-438 10 mg Once Daily | T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 10.52 hour | Standard Deviation 4.3311 |
| TAK-438 10 mg Once Daily | T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 7.879 hour | Standard Deviation 1.2352 |
| TAK-438 10 mg Once Daily | T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 10.82 hour | Standard Deviation 4.0923 |
| TAK-438 10 mg Once Daily | T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 4.753 hour | Standard Deviation 2.443 |
| TAK-438 20 mg Once Daily | T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 10.37 hour | Standard Deviation 2.9973 |
| TAK-438 20 mg Once Daily | T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 6.996 hour | Standard Deviation 1.011 |
| TAK-438 20 mg Once Daily | T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 8.256 hour | Standard Deviation 1.2964 |
| TAK-438 20 mg Once Daily | T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 6.335 hour | Standard Deviation 1.1833 |
| TAK-438 20 mg Once Daily | T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 5.698 hour | Standard Deviation 1.2625 |
| TAK-438 20 mg Twice Daily | T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-IV-Sul | 5.521 hour | Standard Deviation 2.2225 |
| TAK-438 20 mg Twice Daily | T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-III | 6.791 hour | Standard Deviation 0.89228 |
| TAK-438 20 mg Twice Daily | T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | TAK-438F | 7.116 hour | Standard Deviation 0.71638 |
| TAK-438 20 mg Twice Daily | T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-II | 12.29 hour | Standard Deviation 4.0538 |
| TAK-438 20 mg Twice Daily | T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 | M-I | 8.385 hour | Standard Deviation 0.73316 |
Primary
Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9
Time frame: Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose
Population: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TAK-438 10 mg Once Daily | Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 1.750 hour |
| TAK-438 10 mg Once Daily | Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 4.000 hour |
| TAK-438 10 mg Once Daily | Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 1.500 hour |
| TAK-438 10 mg Once Daily | Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 1.500 hour |
| TAK-438 10 mg Once Daily | Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 2.000 hour |
| TAK-438 20 mg Once Daily | Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 3.000 hour |
| TAK-438 20 mg Once Daily | Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 2.000 hour |
| TAK-438 20 mg Once Daily | Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 1.000 hour |
| TAK-438 20 mg Once Daily | Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 2.000 hour |
| TAK-438 20 mg Once Daily | Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 1.500 hour |
| TAK-438 20 mg Twice Daily | Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-IV-Sul | 3.000 hour |
| TAK-438 20 mg Twice Daily | Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-III | 3.000 hour |
| TAK-438 20 mg Twice Daily | Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | TAK-438F | 3.000 hour |
| TAK-438 20 mg Twice Daily | Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-II | 3.500 hour |
| TAK-438 20 mg Twice Daily | Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 | M-I | 2.500 hour |
Primary
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 on Day 1
Time frame: Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Population: The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TAK-438 10 mg Once Daily | 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 on Day 1 | M-III | 1.750 hour |
| TAK-438 10 mg Once Daily | 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 on Day 1 | M-II | 4.010 hour |
| TAK-438 10 mg Once Daily | 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 on Day 1 | TAK-438F | 1.750 hour |
| TAK-438 10 mg Once Daily | 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 on Day 1 | M-I | 1.500 hour |
| TAK-438 10 mg Once Daily | 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 on Day 1 | M-IV-Sul | 1.500 hour |
| TAK-438 20 mg Once Daily | 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 on Day 1 | M-II | 6.000 hour |
| TAK-438 20 mg Once Daily | 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 on Day 1 | TAK-438F | 2.000 hour |
| TAK-438 20 mg Once Daily | 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 on Day 1 | M-I | 1.500 hour |
| TAK-438 20 mg Once Daily | 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 on Day 1 | M-III | 2.000 hour |
| TAK-438 20 mg Once Daily | 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 on Day 1 | M-IV-Sul | 1.500 hour |
| TAK-438 20 mg Twice Daily | 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 on Day 1 | M-IV-Sul | 2.000 hour |
| TAK-438 20 mg Twice Daily | 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 on Day 1 | M-III | 2.000 hour |
| TAK-438 20 mg Twice Daily | 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 on Day 1 | TAK-438F | 2.500 hour |
| TAK-438 20 mg Twice Daily | 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 on Day 1 | M-II | 10.00 hour |
| TAK-438 20 mg Twice Daily | 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 on Day 1 | M-I | 2.000 hour |