Japanese Healthy Adult Male Participants
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of TAK-906 in Japanese healthy male participants.
Detailed description
The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy participants in order to evaluate safety and tolerability of single and multiple oral doses of TAK-906 in Japanese healthy male participants. The study will enroll approximately 24 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups in Cohort 1 or Cohort 3. Study drug will be administered in a double-blind manner which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need), orally, once daily on Day 1 as Single Dose Period and twice daily from Day 3 to 7 as Multiple Dose Period: * TAK-906 50 mg (Cohort 1) * TAK-906 100 mg (Cohort 2) * TAK-906 10 mg (Cohort 3) * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient Cohort 2 will be conducted after the completion of Cohort 1. This will be conducted in Japan.
Interventions
DRUGTAK-906 Placebo
Placebo capsules.
DRUGTAK-906
TAK-906 capsules.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 60 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, aged 20 to 60 years, inclusive, at the time of informed consent. 4. The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 18.5 to 25 kilogram per square meter (kg/m\^2), inclusive at Screening. 5. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from the signing of informed consent to 12 weeks (84 days) after the last dose of study drug. The female partner of a male participant should also be advised to use adequate contraception.
Exclusion criteria
1. The participant has received any investigational compound within 16 weeks (112 days) prior to the first dose of study drug. 2. The participant has received TAK-906 in a previous clinical study or as a therapeutic agent. 3. The participant is an immediate family member of or an investigational site employee, or is in a dependent relationship with an investigational site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress. 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 in the study or potentially confound its results. 5. The participant has a history of any psychiatric disease that would interfere with the evaluation of study drug activity (prolactin concentration) or safety. 6. The participant has a history of seizure or tardive dyskinesia. 7. The participant has a history of hyperprolactinemia, pituitary adenoma, and/or hypothyroidism. 8. The participant has a family history of prolonged QT. 9. The participant has undergone previous gastric bypass surgery or currently had a gastric band fitted. 10. The participant has dysphagia and/or inability to swallow study medication whole. 11. The participant has a known hypersensitivity to any component of the TAK-906 formulation or related compounds. 12. 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, or has a positive urine test result for drugs of abuse or a positive alcohol screen (urine alcohol test/breath test) result for alcohol at Screening. 13. The participant has taken any excluded medication, supplements, or dietary products during the time periods listed in the Excluded Medications, Supplements, and Dietary Products table. 14. If male, the participant intends to donate sperm during the course of this study or for at least 12 weeks (84 days) after the last dose of study drug. 15. The participant has current or recent (within 24 weeks \[168 days\]) gastrointestinal disease 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). 16. 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. 17. 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. 18. The participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 4 weeks (28 days) prior to the first dose of study drug. Cotinine test is positive at Screening. 19. The participant has poor peripheral venous access. 20. The participant has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of study drug administration. 21. The participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of study drug administration. 22. The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of study drug administration. 23. The participant has a Screening or Check-in (Day -1) electrocardiogram (ECG) that was abnormal (clinically significant). 24. The participant has a QTcF of greater than (\>) 450 millisecond (msec) on the ECG at Screening, at Check-in (Day -1), or prior to the first dose of study drug (Day 1 predose). 25. The participant has abnormal Screening or Day -1 laboratory values that suggest a clinically significant underlying disease or any participant with the following lab abnormalities: * Transaminase (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\]) and/or total bilirubin \>1.5 × upper limit of normal (ULN). * Creatinine \>1.2 milligram per deciliter (mg/dL). 26. 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 | Description |
|---|---|---|
| Number of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) | Baseline up to Day 14 | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment or study participation. A treatment-emergent adverse events (TEAE) is defined as an AE whose date of onset occurs on or after the start of study drug. |
| Number of Participants With Markedly Abnormal Values of Vital Signs | Baseline up to Day 14 | Reported data were numbers of participants who met markedly abnormal criteria of vital signs. Vital signs included body temperature, respiratory rate, blood pressure, and pulse. Vital signs collected were classified as markedly abnormal values if they met the following criteria: systolic blood pressure less than (\<) 85 millimeter of mercury (mmHg) or greater than (\>) 180 mmHg, diastolic blood pressure \<50 mmHg or \>110 mmHg, pulse \<50 beats per minute (bpm) or \>120 bpm, body temperature \<35.6 °C or \>37.7 °C. |
| Number of Participants With Markedly Abnormal Values of Clinical Laboratory Test Results | Baseline up to Day 14 | Reported data were numbers of participants who met markedly abnormal criteria of clinical laboratory test results. Clinical laboratory test results collected were classified as markedly abnormal values if they met the following criteria: red blood cells \<0.8×lower limit of normal (LLN) or \>1.2×upper limit of normal (ULN), platelets \<75×10\^3/μL or \>600×10\^3/μL, white blood cells \<0.5×LLN or \>1.5×ULN, protein (total) \<0.8×LLN or \>1.2×ULN, albumin \<2.5 g/dL, blood urea nitrogen \>30 mg/dL, uric acid \>13.0 mg/dL, creatinine \>2.0 mg/dL, total cholesterol \>300 mg/dL, triglycerides \>2.5×ULN, bilirubin (total) \>2.0 mg/dL, Sodium \<130 mEq/L or \>150 mEq/L, Potassium \<3.0 mEq/L or \>6.0 mEq/L, Chloride \<75 mEq/L or \>126 mEq/L, Calcium \<7.0 mg/dL or \>11.5 mg/dL, Phosphorus \<1.6 mg/dL or \>6.2 mg/dL, alkaline phosphatase \>3×ULN, aspartate aminotransferase \>3×ULN, alanine aminotransferase \>3×ULN, gamma-glutamyl transferase \>3×ULN, glucose \<50 mg/dL or \>350 mg/dL, Magnesium \<1.2 mg/dL or \>3.0 mg/dL. |
| Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) | Baseline up to Day 8 | Reported data were numbers of participants who met markedly abnormal criteria of 12-lead ECG. A standard 12-lead ECG was performed. The data collected was classified as markedly abnormal values if it met the following criteria: heart rate \<50 bpm or \>120 bpm, QT interval less than or equal to (\<=) 50 msec or greater than or equal to (\>=) 460 msec, QTcF interval \<=50 msec or either of the following conditions was met: observed value \>=500 msec, change from Day 1 Predose \>= 30 msec and observed value \>=450 msec. |
| Number of Participants With TEAEs Related to Physical Examinations | Baseline up to Day 14 | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment or study participation. A treatment-emergent adverse events (TEAE) is defined as an AE whose date of onset occurs on or after the start of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Day 1 pre-dose and 0-6, 6-12, and 12-24 hours post-dose | Ae(0-24) is the amount of TAK-906 and its metabolite M23 excreted in urine from Time 0 to 24 Hours postdose. |
| Fe24: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to 24 Hours for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose | Time Frame Day 1 pre-dose and 0-6, 6-12, and 12-24 hours post-dose | Fe24 was calculated as percentage of administered dose of drug excreted in urine from Time 0 to 24 Hours for TAK-906 and its metabolite M23. |
| CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Day 1 pre-dose and 0-6, 6-12, and 12-24 hours post-dose | Renal clearance is a measure of apparent clearance of TAK-906 and its metabolite M23 from the urine. |
| AUC(τ,ss): Area Under the Plasma Concentration-time Curve From Time 0 During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose | AUC(τ,ss) is a measure of total plasma exposure to TAK-906 and its metabolite M23 from Time 0 during dosing interval at steady state. |
| Cmax,ss: Maximum Observed Plasma Concentration During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose | Cmax, ss is the peak plasma concentration of TAK-906 and its metabolite M23 during dosing interval at steady state. |
| Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose | Tmax,ss is defined as time to reach the peak plasma concentration at steady state for TAK-906 and its metabolite M23. |
| t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose | t1/2z is time for the plasma concentration of TAK-906 and its metabolite M23 to decrease by half. |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose | AUC∞ is a measure of total plasma exposure to TAK-906 and its Metabolite M23 from Time 0 extrapolated to infinity, calculated using the observed value of the last quantifiable concentration. |
| Fetau: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Day 7 pre-dose and 0-6 and 6-12 hours post-dose | Fetau was calculated as percentage of administered dose of drug excreted in urine from Time 0 to Time tau over the dosing interval for TAK-906 and its metabolite M23. |
| CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Day 7 pre-dose and 0-6 and 6-12 hours post-dose | Renal clearance is a measure of apparent clearance of TAK-906 and its metabolite M23 from the urine. |
| AUCtau: Area Under the Serum Concentration-time Curve During a Dosing Interval for Serum Prolactin on Day 1 of Single Dose Period | Day 1 pre-dose and 1, 2, 4, 6, and 24 hours post-dose | AUCtau defined as area under the serum concentration-time curve during a dosing interval for serum prolactin was calculated. |
| Cmax: Maximum Observed Serum Concentration for Serum Prolactin on Day 1 of Single Dose Period | Day 1 pre-dose and 1, 2, 4, 6, and 24 hours post-dose | Cmax is the peak serum concentration of serum prolactin. |
| AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Serum Prolactin on Day 1 of Single Dose Period | Day 1 pre-dose and 1, 2, 4, 6, and 24 hours post-dose | AUClast defined as area under the serum concentration-time curve from Time 0 to the Time of the last quantifiable concentration for serum prolactin was calculated. |
| AUC(t,ss): Area Under the Serum Concentration-time Curve From Time 0 During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period | Day 7 pre-dose and 1, 2, 4, 6, and 24 hours post-dose | AUC(t,ss) defined as area under the serum concentration-time curve from Time 0 during dosing interval at steady state for serum prolactin was calculated. |
| Cmax,ss: Maximum Observed Serum Concentration During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period | Day 7 pre-dose and 1, 2, 4, 6, and 24 hours post-dose | Cmax,ss is the peak serum concentration of serum prolactin during dosing interval at steady state. |
| Aetau: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Day 7 pre-dose and 0-6 and 6-12 hours post-dose | Aetau is the amount of TAK-906 and its metabolite M23 excreted in urine during a dosing Interval. |
| Cmax: Maximum Observed Plasma Concentration for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose | Cmax is the peak plasma concentration of TAK-906 and its metabolite M23. |
| AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose | AUCtau is a measure of total plasma exposure to TAK-906 and its Metabolite M23 from Time 0 to Time tau over the dosing interval. |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose | Tmax is time to reach the peak plasma concentration of TAK-906 and its metabolite M23. |
| t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose | t1/2z is time for the plasma concentration of TAK-906 and its metabolite M23 to decrease by half. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in Japan from 07 August 2017 to 07 October 2017.
Pre-assignment details
Healthy male participants were enrolled in this study to receive TAK-906 as: single ascending dose and multiple ascending dose of 50 milligram (mg) in Cohort 1, 100 mg in Cohort 2, and 10 mg in Cohort 3.
Participants by arm
| Arm | Count |
|---|---|
| Cohorts 1-3: Placebo TAK-906 placebo-matching capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 placebo-matching capsules, orally twice daily from Day 3 to Day 7 in Multiple Dose Period. | 6 |
| Cohort 1: TAK-906 50 mg TAK-906 50 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 50 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period. | 6 |
| Cohort 2: TAK-906 100 mg TAK-906 100 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 100 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period. | 6 |
| Cohort 3: TAK-906 10 mg TAK-906 10 mg, capsule, orally, once on Day 1 in Single Dose Period, followed by TAK-906 10 mg, capsules, orally, twice daily from Day 3 to Day 7 in Multiple Dose Period. | 6 |
| Total | 24 |
Baseline characteristics
| Characteristic | Cohort 1: TAK-906 50 mg | Total | Cohort 3: TAK-906 10 mg | Cohorts 1-3: Placebo | Cohort 2: TAK-906 100 mg |
|---|---|---|---|---|---|
| Age, Continuous | 27.7 years STANDARD_DEVIATION 4.68 | 28.5 years STANDARD_DEVIATION 5.82 | 29.0 years STANDARD_DEVIATION 4.52 | 29.5 years STANDARD_DEVIATION 6.8 | 27.8 years STANDARD_DEVIATION 8.04 |
| Body Mass Index (BMI) | 21.35 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.871 | 21.76 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.845 | 22.63 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.725 | 21.80 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.107 | 21.25 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.819 |
| Consumption of Alcohol Had a few times per month | 2 Participants | 4 Participants | 0 Participants | 0 Participants | 2 Participants |
| Consumption of Alcohol Had no alcohol consumption | 4 Participants | 20 Participants | 6 Participants | 6 Participants | 4 Participants |
| Consumption of Caffeine Had caffeine consumption | 4 Participants | 10 Participants | 2 Participants | 2 Participants | 2 Participants |
| Consumption of Caffeine Had no caffeine consumption | 2 Participants | 14 Participants | 4 Participants | 4 Participants | 4 Participants |
| Height | 172.0 centimeter (cm) STANDARD_DEVIATION 2.53 | 171.5 centimeter (cm) STANDARD_DEVIATION 4.43 | 171.5 centimeter (cm) STANDARD_DEVIATION 3.89 | 170.2 centimeter (cm) STANDARD_DEVIATION 6.11 | 172.3 centimeter (cm) STANDARD_DEVIATION 5.32 |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — | — |
| Region of Enrollment Japan | 6 participants | 24 participants | 6 participants | 6 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 24 Participants | 6 Participants | 6 Participants | 6 Participants |
| Smoking Classification: Never Smoked | 6 Participants | 24 Participants | 6 Participants | 6 Participants | 6 Participants |
| Weight | 63.12 kilogram (kg) STANDARD_DEVIATION 5.221 | 64.01 kilogram (kg) STANDARD_DEVIATION 6.139 | 66.55 kilogram (kg) STANDARD_DEVIATION 5.375 | 63.20 kilogram (kg) STANDARD_DEVIATION 7.685 | 63.17 kilogram (kg) STANDARD_DEVIATION 6.914 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 1 / 6 | 0 / 6 | 2 / 6 | 1 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Number of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment or study participation. A treatment-emergent adverse events (TEAE) is defined as an AE whose date of onset occurs on or after the start of study drug.
Time frame: Baseline up to Day 14
Population: The safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohorts 1-3: Placebo | Number of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) | 1 Participants |
| Cohort 1: TAK-906 50 mg | Number of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) | 0 Participants |
| Cohort 2: TAK-906 100 mg | Number of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) | 2 Participants |
| Cohort 3: TAK-906 10 mg | Number of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) | 1 Participants |
Primary
Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG)
Reported data were numbers of participants who met markedly abnormal criteria of 12-lead ECG. A standard 12-lead ECG was performed. The data collected was classified as markedly abnormal values if it met the following criteria: heart rate \<50 bpm or \>120 bpm, QT interval less than or equal to (\<=) 50 msec or greater than or equal to (\>=) 460 msec, QTcF interval \<=50 msec or either of the following conditions was met: observed value \>=500 msec, change from Day 1 Predose \>= 30 msec and observed value \>=450 msec.
Time frame: Baseline up to Day 8
Population: The safety analysis set included all participants who received at least 1 dose of the study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohorts 1-3: Placebo | Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) | Heart Rate <50 bpm | 3 Participants |
| Cohorts 1-3: Placebo | Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) | QT Interval >= 460 msec | 1 Participants |
| Cohort 1: TAK-906 50 mg | Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) | QT Interval >= 460 msec | 0 Participants |
| Cohort 1: TAK-906 50 mg | Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) | Heart Rate <50 bpm | 1 Participants |
| Cohort 2: TAK-906 100 mg | Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) | Heart Rate <50 bpm | 3 Participants |
| Cohort 2: TAK-906 100 mg | Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) | QT Interval >= 460 msec | 0 Participants |
| Cohort 3: TAK-906 10 mg | Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) | Heart Rate <50 bpm | 2 Participants |
| Cohort 3: TAK-906 10 mg | Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) | QT Interval >= 460 msec | 0 Participants |
Primary
Number of Participants With Markedly Abnormal Values of Clinical Laboratory Test Results
Reported data were numbers of participants who met markedly abnormal criteria of clinical laboratory test results. Clinical laboratory test results collected were classified as markedly abnormal values if they met the following criteria: red blood cells \<0.8×lower limit of normal (LLN) or \>1.2×upper limit of normal (ULN), platelets \<75×10\^3/μL or \>600×10\^3/μL, white blood cells \<0.5×LLN or \>1.5×ULN, protein (total) \<0.8×LLN or \>1.2×ULN, albumin \<2.5 g/dL, blood urea nitrogen \>30 mg/dL, uric acid \>13.0 mg/dL, creatinine \>2.0 mg/dL, total cholesterol \>300 mg/dL, triglycerides \>2.5×ULN, bilirubin (total) \>2.0 mg/dL, Sodium \<130 mEq/L or \>150 mEq/L, Potassium \<3.0 mEq/L or \>6.0 mEq/L, Chloride \<75 mEq/L or \>126 mEq/L, Calcium \<7.0 mg/dL or \>11.5 mg/dL, Phosphorus \<1.6 mg/dL or \>6.2 mg/dL, alkaline phosphatase \>3×ULN, aspartate aminotransferase \>3×ULN, alanine aminotransferase \>3×ULN, gamma-glutamyl transferase \>3×ULN, glucose \<50 mg/dL or \>350 mg/dL, Magnesium \<1.2 mg/dL or \>3.0 mg/dL.
Time frame: Baseline up to Day 14
Population: The safety analysis set included all participants who received at least 1 dose of the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohorts 1-3: Placebo | Number of Participants With Markedly Abnormal Values of Clinical Laboratory Test Results | 0 Participants |
| Cohort 1: TAK-906 50 mg | Number of Participants With Markedly Abnormal Values of Clinical Laboratory Test Results | 0 Participants |
| Cohort 2: TAK-906 100 mg | Number of Participants With Markedly Abnormal Values of Clinical Laboratory Test Results | 0 Participants |
| Cohort 3: TAK-906 10 mg | Number of Participants With Markedly Abnormal Values of Clinical Laboratory Test Results | 0 Participants |
Primary
Number of Participants With Markedly Abnormal Values of Vital Signs
Reported data were numbers of participants who met markedly abnormal criteria of vital signs. Vital signs included body temperature, respiratory rate, blood pressure, and pulse. Vital signs collected were classified as markedly abnormal values if they met the following criteria: systolic blood pressure less than (\<) 85 millimeter of mercury (mmHg) or greater than (\>) 180 mmHg, diastolic blood pressure \<50 mmHg or \>110 mmHg, pulse \<50 beats per minute (bpm) or \>120 bpm, body temperature \<35.6 °C or \>37.7 °C.
Time frame: Baseline up to Day 14
Population: The safety analysis set included all participants who received at least 1 dose of the study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohorts 1-3: Placebo | Number of Participants With Markedly Abnormal Values of Vital Signs | Diastolic blood pressure <50 mmHg | 2 Participants |
| Cohorts 1-3: Placebo | Number of Participants With Markedly Abnormal Values of Vital Signs | Pulse < 50 bpm | 3 Participants |
| Cohort 1: TAK-906 50 mg | Number of Participants With Markedly Abnormal Values of Vital Signs | Pulse < 50 bpm | 2 Participants |
| Cohort 1: TAK-906 50 mg | Number of Participants With Markedly Abnormal Values of Vital Signs | Diastolic blood pressure <50 mmHg | 1 Participants |
| Cohort 2: TAK-906 100 mg | Number of Participants With Markedly Abnormal Values of Vital Signs | Diastolic blood pressure <50 mmHg | 2 Participants |
| Cohort 2: TAK-906 100 mg | Number of Participants With Markedly Abnormal Values of Vital Signs | Pulse < 50 bpm | 2 Participants |
| Cohort 3: TAK-906 10 mg | Number of Participants With Markedly Abnormal Values of Vital Signs | Diastolic blood pressure <50 mmHg | 1 Participants |
| Cohort 3: TAK-906 10 mg | Number of Participants With Markedly Abnormal Values of Vital Signs | Pulse < 50 bpm | 2 Participants |
Primary
Number of Participants With TEAEs Related to Physical Examinations
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment or study participation. A treatment-emergent adverse events (TEAE) is defined as an AE whose date of onset occurs on or after the start of study drug.
Time frame: Baseline up to Day 14
Population: The safety analysis set included all participants who received at least 1 dose of the study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohorts 1-3: Placebo | Number of Participants With TEAEs Related to Physical Examinations | 0 Participants |
| Cohort 1: TAK-906 50 mg | Number of Participants With TEAEs Related to Physical Examinations | 0 Participants |
| Cohort 2: TAK-906 100 mg | Number of Participants With TEAEs Related to Physical Examinations | 0 Participants |
| Cohort 3: TAK-906 10 mg | Number of Participants With TEAEs Related to Physical Examinations | 0 Participants |
Secondary
Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period
Ae(0-24) is the amount of TAK-906 and its metabolite M23 excreted in urine from Time 0 to 24 Hours postdose.
Time frame: Day 1 pre-dose and 0-6, 6-12, and 12-24 hours post-dose
Population: The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3: Placebo | Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 741.2 microgram (mcg) | Standard Deviation 114.12 |
| Cohorts 1-3: Placebo | Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 64.57 microgram (mcg) | Standard Deviation 23.741 |
| Cohort 1: TAK-906 50 mg | Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 1571 microgram (mcg) | Standard Deviation 621.57 |
| Cohort 1: TAK-906 50 mg | Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 135.2 microgram (mcg) | Standard Deviation 80.915 |
| Cohort 2: TAK-906 100 mg | Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 160.0 microgram (mcg) | Standard Deviation 29.766 |
| Cohort 2: TAK-906 100 mg | Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 13.27 microgram (mcg) | Standard Deviation 6.5007 |
Secondary
Aetau: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period
Aetau is the amount of TAK-906 and its metabolite M23 excreted in urine during a dosing Interval.
Time frame: Day 7 pre-dose and 0-6 and 6-12 hours post-dose
Population: The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3: Placebo | Aetau: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 895.8 mcg | Standard Deviation 179.72 |
| Cohorts 1-3: Placebo | Aetau: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 78.75 mcg | Standard Deviation 29.365 |
| Cohort 1: TAK-906 50 mg | Aetau: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 2155 mcg | Standard Deviation 358.71 |
| Cohort 1: TAK-906 50 mg | Aetau: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 237.7 mcg | Standard Deviation 109.04 |
| Cohort 2: TAK-906 100 mg | Aetau: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 198.7 mcg | Standard Deviation 28.14 |
| Cohort 2: TAK-906 100 mg | Aetau: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 16.11 mcg | Standard Deviation 7.2989 |
Secondary
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period
AUC∞ is a measure of total plasma exposure to TAK-906 and its Metabolite M23 from Time 0 extrapolated to infinity, calculated using the observed value of the last quantifiable concentration.
Time frame: Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose
Population: The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3: Placebo | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 72.58 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 17.329 |
| Cohorts 1-3: Placebo | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 7.869 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 2.126 |
| Cohort 1: TAK-906 50 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 156.9 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 38.048 |
| Cohort 1: TAK-906 50 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 16.05 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 7.5395 |
| Cohort 2: TAK-906 100 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 13.71 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 2.1631 |
| Cohort 2: TAK-906 100 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 1.602 hour*nanogram per milliliter (h*ng/mL) | Standard Deviation 0.46441 |
Secondary
AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Serum Prolactin on Day 1 of Single Dose Period
AUClast defined as area under the serum concentration-time curve from Time 0 to the Time of the last quantifiable concentration for serum prolactin was calculated.
Time frame: Day 1 pre-dose and 1, 2, 4, 6, and 24 hours post-dose
Population: The PD analysis set consisted of participants who received at least 1 dose of study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PD.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohorts 1-3: Placebo | AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Serum Prolactin on Day 1 of Single Dose Period | 174.5 h*ng/mL | Standard Deviation 26.584 |
| Cohort 1: TAK-906 50 mg | AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Serum Prolactin on Day 1 of Single Dose Period | 544.9 h*ng/mL | Standard Deviation 120.83 |
| Cohort 2: TAK-906 100 mg | AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Serum Prolactin on Day 1 of Single Dose Period | 638.8 h*ng/mL | Standard Deviation 171.24 |
| Cohort 3: TAK-906 10 mg | AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Serum Prolactin on Day 1 of Single Dose Period | 449.9 h*ng/mL | Standard Deviation 167.52 |
Secondary
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period
AUCtau is a measure of total plasma exposure to TAK-906 and its Metabolite M23 from Time 0 to Time tau over the dosing interval.
Time frame: Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose
Population: The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3: Placebo | AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 70.96 h*ng/mL | Standard Deviation 16.586 |
| Cohorts 1-3: Placebo | AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 7.608 h*ng/mL | Standard Deviation 1.8894 |
| Cohort 1: TAK-906 50 mg | AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 149.1 h*ng/mL | Standard Deviation 39.145 |
| Cohort 1: TAK-906 50 mg | AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 14.69 h*ng/mL | Standard Deviation 6.852 |
| Cohort 2: TAK-906 100 mg | AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 13.47 h*ng/mL | Standard Deviation 2.013 |
| Cohort 2: TAK-906 100 mg | AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 1.327 h*ng/mL | Standard Deviation 0.60977 |
Secondary
AUCtau: Area Under the Serum Concentration-time Curve During a Dosing Interval for Serum Prolactin on Day 1 of Single Dose Period
AUCtau defined as area under the serum concentration-time curve during a dosing interval for serum prolactin was calculated.
Time frame: Day 1 pre-dose and 1, 2, 4, 6, and 24 hours post-dose
Population: The pharmacodynamics (PD) analysis set consisted of participants who received at least 1 dose of study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PD.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohorts 1-3: Placebo | AUCtau: Area Under the Serum Concentration-time Curve During a Dosing Interval for Serum Prolactin on Day 1 of Single Dose Period | 79.66 h*ng/mL | Standard Deviation 12.529 |
| Cohort 1: TAK-906 50 mg | AUCtau: Area Under the Serum Concentration-time Curve During a Dosing Interval for Serum Prolactin on Day 1 of Single Dose Period | 362.9 h*ng/mL | Standard Deviation 101.53 |
| Cohort 2: TAK-906 100 mg | AUCtau: Area Under the Serum Concentration-time Curve During a Dosing Interval for Serum Prolactin on Day 1 of Single Dose Period | 398.7 h*ng/mL | Standard Deviation 151.86 |
| Cohort 3: TAK-906 10 mg | AUCtau: Area Under the Serum Concentration-time Curve During a Dosing Interval for Serum Prolactin on Day 1 of Single Dose Period | 317.4 h*ng/mL | Standard Deviation 136.71 |
Secondary
AUC(t,ss): Area Under the Serum Concentration-time Curve From Time 0 During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period
AUC(t,ss) defined as area under the serum concentration-time curve from Time 0 during dosing interval at steady state for serum prolactin was calculated.
Time frame: Day 7 pre-dose and 1, 2, 4, 6, and 24 hours post-dose
Population: The PD analysis set consisted of participants who received at least 1 dose of study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PD.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohorts 1-3: Placebo | AUC(t,ss): Area Under the Serum Concentration-time Curve From Time 0 During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period | 75.40 h*ng/mL | Standard Deviation 9.8027 |
| Cohort 1: TAK-906 50 mg | AUC(t,ss): Area Under the Serum Concentration-time Curve From Time 0 During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period | 354.8 h*ng/mL | Standard Deviation 142.68 |
| Cohort 2: TAK-906 100 mg | AUC(t,ss): Area Under the Serum Concentration-time Curve From Time 0 During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period | 476.2 h*ng/mL | Standard Deviation 122.05 |
| Cohort 3: TAK-906 10 mg | AUC(t,ss): Area Under the Serum Concentration-time Curve From Time 0 During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period | 317.0 h*ng/mL | Standard Deviation 147.7 |
Secondary
AUC(τ,ss): Area Under the Plasma Concentration-time Curve From Time 0 During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period
AUC(τ,ss) is a measure of total plasma exposure to TAK-906 and its metabolite M23 from Time 0 during dosing interval at steady state.
Time frame: Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose
Population: The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3: Placebo | AUC(τ,ss): Area Under the Plasma Concentration-time Curve From Time 0 During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 89.01 h*ng/mL | Standard Deviation 9.0816 |
| Cohorts 1-3: Placebo | AUC(τ,ss): Area Under the Plasma Concentration-time Curve From Time 0 During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 9.881 h*ng/mL | Standard Deviation 2.7666 |
| Cohort 1: TAK-906 50 mg | AUC(τ,ss): Area Under the Plasma Concentration-time Curve From Time 0 During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 186.6 h*ng/mL | Standard Deviation 9.5795 |
| Cohort 1: TAK-906 50 mg | AUC(τ,ss): Area Under the Plasma Concentration-time Curve From Time 0 During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 25.35 h*ng/mL | Standard Deviation 9.435 |
| Cohort 2: TAK-906 100 mg | AUC(τ,ss): Area Under the Plasma Concentration-time Curve From Time 0 During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 16.28 h*ng/mL | Standard Deviation 1.6646 |
| Cohort 2: TAK-906 100 mg | AUC(τ,ss): Area Under the Plasma Concentration-time Curve From Time 0 During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 1.672 h*ng/mL | Standard Deviation 0.48714 |
Secondary
CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period
Renal clearance is a measure of apparent clearance of TAK-906 and its metabolite M23 from the urine.
Time frame: Day 1 pre-dose and 0-6, 6-12, and 12-24 hours post-dose
Population: The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3: Placebo | CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 10.31 liter per hour (L/h) | Standard Deviation 1.9096 |
| Cohorts 1-3: Placebo | CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 8.021 liter per hour (L/h) | Standard Deviation 1.6016 |
| Cohort 1: TAK-906 50 mg | CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 7.782 liter per hour (L/h) | Standard Deviation 2.0366 |
| Cohort 1: TAK-906 50 mg | CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 9.741 liter per hour (L/h) | Standard Deviation 2.5812 |
| Cohort 2: TAK-906 100 mg | CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 11.76 liter per hour (L/h) | Standard Deviation 2.4737 |
| Cohort 2: TAK-906 100 mg | CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 9.204 liter per hour (L/h) | Standard Deviation 2.8328 |
Secondary
CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period
Renal clearance is a measure of apparent clearance of TAK-906 and its metabolite M23 from the urine.
Time frame: Day 7 pre-dose and 0-6 and 6-12 hours post-dose
Population: The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3: Placebo | CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 10.04 L/h | Standard Deviation 1.8881 |
| Cohorts 1-3: Placebo | CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 7.744 L/h | Standard Deviation 1.611 |
| Cohort 1: TAK-906 50 mg | CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 11.50 L/h | Standard Deviation 1.5423 |
| Cohort 1: TAK-906 50 mg | CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 8.669 L/h | Standard Deviation 0.99318 |
| Cohort 2: TAK-906 100 mg | CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 12.21 L/h | Standard Deviation 1.762 |
| Cohort 2: TAK-906 100 mg | CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 9.113 L/h | Standard Deviation 2.2294 |
Secondary
Cmax: Maximum Observed Plasma Concentration for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period
Cmax is the peak plasma concentration of TAK-906 and its metabolite M23.
Time frame: Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose
Population: The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 35.31 nanogram per milliliter (ng/mL) | Standard Deviation 12.255 |
| Cohorts 1-3: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 3.082 nanogram per milliliter (ng/mL) | Standard Deviation 0.63298 |
| Cohort 1: TAK-906 50 mg | Cmax: Maximum Observed Plasma Concentration for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 58.21 nanogram per milliliter (ng/mL) | Standard Deviation 28.491 |
| Cohort 1: TAK-906 50 mg | Cmax: Maximum Observed Plasma Concentration for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 4.412 nanogram per milliliter (ng/mL) | Standard Deviation 3.0329 |
| Cohort 2: TAK-906 100 mg | Cmax: Maximum Observed Plasma Concentration for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 6.951 nanogram per milliliter (ng/mL) | Standard Deviation 2.038 |
| Cohort 2: TAK-906 100 mg | Cmax: Maximum Observed Plasma Concentration for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 0.5088 nanogram per milliliter (ng/mL) | Standard Deviation 0.28496 |
Secondary
Cmax: Maximum Observed Serum Concentration for Serum Prolactin on Day 1 of Single Dose Period
Cmax is the peak serum concentration of serum prolactin.
Time frame: Day 1 pre-dose and 1, 2, 4, 6, and 24 hours post-dose
Population: The PD analysis set consisted of participants who received at least 1 dose of study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PD.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohorts 1-3: Placebo | Cmax: Maximum Observed Serum Concentration for Serum Prolactin on Day 1 of Single Dose Period | 10.68 ng/mL | Standard Deviation 1.95 |
| Cohort 1: TAK-906 50 mg | Cmax: Maximum Observed Serum Concentration for Serum Prolactin on Day 1 of Single Dose Period | 73.12 ng/mL | Standard Deviation 37.398 |
| Cohort 2: TAK-906 100 mg | Cmax: Maximum Observed Serum Concentration for Serum Prolactin on Day 1 of Single Dose Period | 81.09 ng/mL | Standard Deviation 55.593 |
| Cohort 3: TAK-906 10 mg | Cmax: Maximum Observed Serum Concentration for Serum Prolactin on Day 1 of Single Dose Period | 82.33 ng/mL | Standard Deviation 45.405 |
Secondary
Cmax,ss: Maximum Observed Plasma Concentration During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period
Cmax, ss is the peak plasma concentration of TAK-906 and its metabolite M23 during dosing interval at steady state.
Time frame: Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose
Population: The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3: Placebo | Cmax,ss: Maximum Observed Plasma Concentration During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 46.47 ng/mL | Standard Deviation 12.173 |
| Cohorts 1-3: Placebo | Cmax,ss: Maximum Observed Plasma Concentration During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 3.858 ng/mL | Standard Deviation 2.2739 |
| Cohort 1: TAK-906 50 mg | Cmax,ss: Maximum Observed Plasma Concentration During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 79.36 ng/mL | Standard Deviation 19.958 |
| Cohort 1: TAK-906 50 mg | Cmax,ss: Maximum Observed Plasma Concentration During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 8.119 ng/mL | Standard Deviation 4.0837 |
| Cohort 2: TAK-906 100 mg | Cmax,ss: Maximum Observed Plasma Concentration During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 7.642 ng/mL | Standard Deviation 2.863 |
| Cohort 2: TAK-906 100 mg | Cmax,ss: Maximum Observed Plasma Concentration During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 0.5309 ng/mL | Standard Deviation 0.24586 |
Secondary
Cmax,ss: Maximum Observed Serum Concentration During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period
Cmax,ss is the peak serum concentration of serum prolactin during dosing interval at steady state.
Time frame: Day 7 pre-dose and 1, 2, 4, 6, and 24 hours post-dose
Population: The PD analysis set consisted of participants who received at least 1 dose of study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PD.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohorts 1-3: Placebo | Cmax,ss: Maximum Observed Serum Concentration During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period | 11.48 ng/mL | Standard Deviation 3.4891 |
| Cohort 1: TAK-906 50 mg | Cmax,ss: Maximum Observed Serum Concentration During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period | 39.65 ng/mL | Standard Deviation 16.014 |
| Cohort 2: TAK-906 100 mg | Cmax,ss: Maximum Observed Serum Concentration During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period | 55.89 ng/mL | Standard Deviation 20.89 |
| Cohort 3: TAK-906 10 mg | Cmax,ss: Maximum Observed Serum Concentration During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period | 71.02 ng/mL | Standard Deviation 38.025 |
Secondary
Fe24: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to 24 Hours for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose
Fe24 was calculated as percentage of administered dose of drug excreted in urine from Time 0 to 24 Hours for TAK-906 and its metabolite M23.
Time frame: Time Frame Day 1 pre-dose and 0-6, 6-12, and 12-24 hours post-dose
Population: The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3: Placebo | Fe24: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to 24 Hours for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose | TAK-906 | 1.815 percentage of drug | Standard Deviation 0.27941 |
| Cohorts 1-3: Placebo | Fe24: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to 24 Hours for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose | Metabolite M23 | 0.1575 percentage of drug | Standard Deviation 0.057901 |
| Cohort 1: TAK-906 50 mg | Fe24: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to 24 Hours for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose | TAK-906 | 1.923 percentage of drug | Standard Deviation 0.76094 |
| Cohort 1: TAK-906 50 mg | Fe24: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to 24 Hours for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose | Metabolite M23 | 0.1648 percentage of drug | Standard Deviation 0.098672 |
| Cohort 2: TAK-906 100 mg | Fe24: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to 24 Hours for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose | TAK-906 | 1.959 percentage of drug | Standard Deviation 0.3644 |
| Cohort 2: TAK-906 100 mg | Fe24: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to 24 Hours for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose | Metabolite M23 | 0.1618 percentage of drug | Standard Deviation 0.079274 |
Secondary
Fetau: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period
Fetau was calculated as percentage of administered dose of drug excreted in urine from Time 0 to Time tau over the dosing interval for TAK-906 and its metabolite M23.
Time frame: Day 7 pre-dose and 0-6 and 6-12 hours post-dose
Population: The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3: Placebo | Fetau: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 2.193 percentage of drug | Standard Deviation 0.44004 |
| Cohorts 1-3: Placebo | Fetau: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 0.1921 percentage of drug | Standard Deviation 0.071618 |
| Cohort 1: TAK-906 50 mg | Fetau: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 2.638 percentage of drug | Standard Deviation 0.43913 |
| Cohort 1: TAK-906 50 mg | Fetau: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 0.2898 percentage of drug | Standard Deviation 0.13297 |
| Cohort 2: TAK-906 100 mg | Fetau: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 2.432 percentage of drug | Standard Deviation 0.3445 |
| Cohort 2: TAK-906 100 mg | Fetau: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 0.1965 percentage of drug | Standard Deviation 0.089007 |
Secondary
t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period
t1/2z is time for the plasma concentration of TAK-906 and its metabolite M23 to decrease by half.
Time frame: Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose
Population: The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3: Placebo | t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 4.692 hours | Standard Deviation 3.8389 |
| Cohorts 1-3: Placebo | t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 2.483 hours | Standard Deviation 1.216 |
| Cohort 1: TAK-906 50 mg | t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 5.152 hours | Standard Deviation 2.1478 |
| Cohort 1: TAK-906 50 mg | t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 4.423 hours | Standard Deviation 3.0935 |
| Cohort 2: TAK-906 100 mg | t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 1.894 hours | Standard Deviation 0.85198 |
| Cohort 2: TAK-906 100 mg | t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 3.170 hours | Standard Deviation 2.2826 |
Secondary
t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period
t1/2z is time for the plasma concentration of TAK-906 and its metabolite M23 to decrease by half.
Time frame: Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose
Population: The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohorts 1-3: Placebo | t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 6.447 hour | Standard Deviation 2.4506 |
| Cohorts 1-3: Placebo | t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 5.573 hour | Standard Deviation 2.781 |
| Cohort 1: TAK-906 50 mg | t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 4.407 hour | Standard Deviation 1.1057 |
| Cohort 1: TAK-906 50 mg | t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 4.598 hour | Standard Deviation 0.85968 |
| Cohort 2: TAK-906 100 mg | t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 3.727 hour | Standard Deviation 2.9253 |
| Cohort 2: TAK-906 100 mg | t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 3.037 hour | Standard Deviation 2.8804 |
Secondary
Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period
Tmax,ss is defined as time to reach the peak plasma concentration at steady state for TAK-906 and its metabolite M23.
Time frame: Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose
Population: The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohorts 1-3: Placebo | Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 1.000 hours |
| Cohorts 1-3: Placebo | Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 1.000 hours |
| Cohort 1: TAK-906 50 mg | Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 1.250 hours |
| Cohort 1: TAK-906 50 mg | Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 1.500 hours |
| Cohort 2: TAK-906 100 mg | Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | TAK-906 | 1.000 hours |
| Cohort 2: TAK-906 100 mg | Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period | Metabolite M23 | 1.000 hours |
Secondary
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period
Tmax is time to reach the peak plasma concentration of TAK-906 and its metabolite M23.
Time frame: Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose
Population: The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohorts 1-3: Placebo | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 1.000 hours |
| Cohorts 1-3: Placebo | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 1.000 hours |
| Cohort 1: TAK-906 50 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 1.000 hours |
| Cohort 1: TAK-906 50 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 1.000 hours |
| Cohort 2: TAK-906 100 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | TAK-906 | 1.000 hours |
| Cohort 2: TAK-906 100 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period | Metabolite M23 | 1.000 hours |