Trial Outcomes & Findings for Phase 1 TAK-906 Single and Multiple Ascending Dose Study in Japanese Healthy Male Participants (NCT NCT03237156)
NCT ID: NCT03237156
Last Updated: 2021-01-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Baseline up to Day 14
Results posted on
2021-01-12
Participant Flow
Participants took part in the study at 1 investigative site in Japan from 07 August 2017 to 07 October 2017.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
Cohort 3: TAK-906 10 mg
n=6 Participants
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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 6.80 • n=6 Participants
|
27.7 years
STANDARD_DEVIATION 4.68 • n=6 Participants
|
27.8 years
STANDARD_DEVIATION 8.04 • n=6 Participants
|
29.0 years
STANDARD_DEVIATION 4.52 • n=6 Participants
|
28.5 years
STANDARD_DEVIATION 5.82 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
24 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
24 participants
n=24 Participants
|
|
Height
|
170.2 centimeter (cm)
STANDARD_DEVIATION 6.11 • n=6 Participants
|
172.0 centimeter (cm)
STANDARD_DEVIATION 2.53 • n=6 Participants
|
172.3 centimeter (cm)
STANDARD_DEVIATION 5.32 • n=6 Participants
|
171.5 centimeter (cm)
STANDARD_DEVIATION 3.89 • n=6 Participants
|
171.5 centimeter (cm)
STANDARD_DEVIATION 4.43 • n=24 Participants
|
|
Weight
|
63.20 kilogram (kg)
STANDARD_DEVIATION 7.685 • n=6 Participants
|
63.12 kilogram (kg)
STANDARD_DEVIATION 5.221 • n=6 Participants
|
63.17 kilogram (kg)
STANDARD_DEVIATION 6.914 • n=6 Participants
|
66.55 kilogram (kg)
STANDARD_DEVIATION 5.375 • n=6 Participants
|
64.01 kilogram (kg)
STANDARD_DEVIATION 6.139 • n=24 Participants
|
|
Body Mass Index (BMI)
|
21.80 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.107 • n=6 Participants
|
21.35 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.871 • n=6 Participants
|
21.25 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.819 • n=6 Participants
|
22.63 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.725 • n=6 Participants
|
21.76 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.845 • n=24 Participants
|
|
Smoking Classification: Never Smoked
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
24 Participants
n=24 Participants
|
|
Consumption of Alcohol
Had a few times per month
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=24 Participants
|
|
Consumption of Alcohol
Had no alcohol consumption
|
6 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
20 Participants
n=24 Participants
|
|
Consumption of Caffeine
Had caffeine consumption
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
10 Participants
n=24 Participants
|
|
Consumption of Caffeine
Had no caffeine consumption
|
4 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
14 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 14Population: The safety analysis set included all participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
Cohort 3: TAK-906 10 mg
n=6 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE)
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 14Population: The safety analysis set included all participants who received at least 1 dose of the study drug.
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.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
Cohort 3: TAK-906 10 mg
n=6 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Markedly Abnormal Values of Vital Signs
Pulse < 50 bpm
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Values of Vital Signs
Diastolic blood pressure <50 mmHg
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 14Population: The safety analysis set included all participants who received at least 1 dose of the study drug.
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.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
Cohort 3: TAK-906 10 mg
n=6 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Markedly Abnormal Values of Clinical Laboratory Test Results
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 8Population: The safety analysis set included all participants who received at least 1 dose of the study drug.
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.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
Cohort 3: TAK-906 10 mg
n=6 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG)
Heart Rate <50 bpm
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG)
QT Interval >= 460 msec
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 14Population: The safety analysis set included all participants who received at least 1 dose of the study drug.
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.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
Cohort 3: TAK-906 10 mg
n=6 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Physical Examinations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|
|
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
|
156.9 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 38.048
|
13.71 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 2.1631
|
—
|
|
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 2.1260
|
16.05 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 7.5395
|
1.602 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 0.46441
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dosePopulation: 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.
Cmax is the peak plasma concentration of TAK-906 and its metabolite M23.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|
|
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
|
58.21 nanogram per milliliter (ng/mL)
Standard Deviation 28.491
|
6.951 nanogram per milliliter (ng/mL)
Standard Deviation 2.0380
|
—
|
|
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
|
4.412 nanogram per milliliter (ng/mL)
Standard Deviation 3.0329
|
0.5088 nanogram per milliliter (ng/mL)
Standard Deviation 0.28496
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|
|
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
|
149.1 h*ng/mL
Standard Deviation 39.145
|
13.47 h*ng/mL
Standard Deviation 2.0130
|
—
|
|
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
|
14.69 h*ng/mL
Standard Deviation 6.8520
|
1.327 h*ng/mL
Standard Deviation 0.60977
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dosePopulation: 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.
Tmax is time to reach the peak plasma concentration of TAK-906 and its metabolite M23.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|
|
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
Interval 1.0 to 2.0
|
1.000 hours
Interval 0.5 to 3.0
|
1.000 hours
Interval 1.0 to 1.5
|
—
|
|
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
Interval 1.0 to 2.0
|
1.000 hours
Interval 1.0 to 4.0
|
1.000 hours
Interval 1.0 to 1.5
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dosePopulation: 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.
t1/2z is time for the plasma concentration of TAK-906 and its metabolite M23 to decrease by half.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|
|
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
|
5.152 hours
Standard Deviation 2.1478
|
1.894 hours
Standard Deviation 0.85198
|
—
|
|
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 1.2160
|
4.423 hours
Standard Deviation 3.0935
|
3.170 hours
Standard Deviation 2.2826
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and 0-6, 6-12, and 12-24 hours post-dosePopulation: 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.
Ae(0-24) is the amount of TAK-906 and its metabolite M23 excreted in urine from Time 0 to 24 Hours postdose.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|
|
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
|
1571 microgram (mcg)
Standard Deviation 621.57
|
160.0 microgram (mcg)
Standard Deviation 29.766
|
—
|
|
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
|
135.2 microgram (mcg)
Standard Deviation 80.915
|
13.27 microgram (mcg)
Standard Deviation 6.5007
|
—
|
SECONDARY outcome
Timeframe: Time Frame Day 1 pre-dose and 0-6, 6-12, and 12-24 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|
|
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
|
1.923 percentage of drug
Standard Deviation 0.76094
|
1.959 percentage of drug
Standard Deviation 0.36440
|
—
|
|
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
|
0.1648 percentage of drug
Standard Deviation 0.098672
|
0.1618 percentage of drug
Standard Deviation 0.079274
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and 0-6, 6-12, and 12-24 hours post-dosePopulation: 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.
Renal clearance is a measure of apparent clearance of TAK-906 and its metabolite M23 from the urine.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|
|
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
|
7.782 liter per hour (L/h)
Standard Deviation 2.0366
|
9.204 liter per hour (L/h)
Standard Deviation 2.8328
|
—
|
|
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
|
9.741 liter per hour (L/h)
Standard Deviation 2.5812
|
11.76 liter per hour (L/h)
Standard Deviation 2.4737
|
—
|
SECONDARY outcome
Timeframe: Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|
|
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
|
186.6 h*ng/mL
Standard Deviation 9.5795
|
16.28 h*ng/mL
Standard Deviation 1.6646
|
—
|
|
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
|
25.35 h*ng/mL
Standard Deviation 9.4350
|
1.672 h*ng/mL
Standard Deviation 0.48714
|
—
|
SECONDARY outcome
Timeframe: Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dosePopulation: 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.
Cmax, ss is the peak plasma concentration of TAK-906 and its metabolite M23 during dosing interval at steady state.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|
|
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
|
79.36 ng/mL
Standard Deviation 19.958
|
7.642 ng/mL
Standard Deviation 2.8630
|
—
|
|
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
|
8.119 ng/mL
Standard Deviation 4.0837
|
0.5309 ng/mL
Standard Deviation 0.24586
|
—
|
SECONDARY outcome
Timeframe: Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dosePopulation: 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.
Tmax,ss is defined as time to reach the peak plasma concentration at steady state for TAK-906 and its metabolite M23.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|
|
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
Interval 0.5 to 1.5
|
1.250 hours
Interval 1.0 to 2.0
|
1.000 hours
Interval 0.5 to 1.0
|
—
|
|
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
Interval 0.5 to 1.5
|
1.500 hours
Interval 1.0 to 2.0
|
1.000 hours
Interval 1.0 to 1.5
|
—
|
SECONDARY outcome
Timeframe: Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dosePopulation: 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.
t1/2z is time for the plasma concentration of TAK-906 and its metabolite M23 to decrease by half.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|
|
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
|
4.407 hour
Standard Deviation 1.1057
|
3.727 hour
Standard Deviation 2.9253
|
—
|
|
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 2.7810
|
4.598 hour
Standard Deviation 0.85968
|
3.037 hour
Standard Deviation 2.8804
|
—
|
SECONDARY outcome
Timeframe: Day 7 pre-dose and 0-6 and 6-12 hours post-dosePopulation: 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.
Aetau is the amount of TAK-906 and its metabolite M23 excreted in urine during a dosing Interval.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|
|
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
|
2155 mcg
Standard Deviation 358.71
|
198.7 mcg
Standard Deviation 28.140
|
—
|
|
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
|
237.7 mcg
Standard Deviation 109.04
|
16.11 mcg
Standard Deviation 7.2989
|
—
|
SECONDARY outcome
Timeframe: Day 7 pre-dose and 0-6 and 6-12 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|
|
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
|
2.638 percentage of drug
Standard Deviation 0.43913
|
2.432 percentage of drug
Standard Deviation 0.34450
|
—
|
|
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
|
0.2898 percentage of drug
Standard Deviation 0.13297
|
0.1965 percentage of drug
Standard Deviation 0.089007
|
—
|
SECONDARY outcome
Timeframe: Day 7 pre-dose and 0-6 and 6-12 hours post-dosePopulation: 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.
Renal clearance is a measure of apparent clearance of TAK-906 and its metabolite M23 from the urine.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
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.
|
|---|---|---|---|---|
|
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
|
11.50 L/h
Standard Deviation 1.5423
|
12.21 L/h
Standard Deviation 1.7620
|
—
|
|
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 1.6110
|
8.669 L/h
Standard Deviation 0.99318
|
9.113 L/h
Standard Deviation 2.2294
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and 1, 2, 4, 6, and 24 hours post-dosePopulation: 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.
AUCtau defined as area under the serum concentration-time curve during a dosing interval for serum prolactin was calculated.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
Cohort 3: TAK-906 10 mg
n=6 Participants
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.
|
|---|---|---|---|---|
|
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
|
362.9 h*ng/mL
Standard Deviation 101.53
|
398.7 h*ng/mL
Standard Deviation 151.86
|
317.4 h*ng/mL
Standard Deviation 136.71
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and 1, 2, 4, 6, and 24 hours post-dosePopulation: 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.
Cmax is the peak serum concentration of serum prolactin.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
Cohort 3: TAK-906 10 mg
n=6 Participants
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.
|
|---|---|---|---|---|
|
Cmax: Maximum Observed Serum Concentration for Serum Prolactin on Day 1 of Single Dose Period
|
10.68 ng/mL
Standard Deviation 1.9500
|
73.12 ng/mL
Standard Deviation 37.398
|
81.09 ng/mL
Standard Deviation 55.593
|
82.33 ng/mL
Standard Deviation 45.405
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and 1, 2, 4, 6, and 24 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
Cohort 3: TAK-906 10 mg
n=6 Participants
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.
|
|---|---|---|---|---|
|
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
|
544.9 h*ng/mL
Standard Deviation 120.83
|
638.8 h*ng/mL
Standard Deviation 171.24
|
449.9 h*ng/mL
Standard Deviation 167.52
|
SECONDARY outcome
Timeframe: Day 7 pre-dose and 1, 2, 4, 6, and 24 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
Cohort 3: TAK-906 10 mg
n=6 Participants
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.
|
|---|---|---|---|---|
|
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
|
354.8 h*ng/mL
Standard Deviation 142.68
|
476.2 h*ng/mL
Standard Deviation 122.05
|
317.0 h*ng/mL
Standard Deviation 147.70
|
SECONDARY outcome
Timeframe: Day 7 pre-dose and 1, 2, 4, 6, and 24 hours post-dosePopulation: 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.
Cmax,ss is the peak serum concentration of serum prolactin during dosing interval at steady state.
Outcome measures
| Measure |
Cohorts 1-3: Placebo
n=6 Participants
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.
|
Cohort 1: TAK-906 50 mg
n=6 Participants
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.
|
Cohort 2: TAK-906 100 mg
n=6 Participants
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.
|
Cohort 3: TAK-906 10 mg
n=6 Participants
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.
|
|---|---|---|---|---|
|
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
|
39.65 ng/mL
Standard Deviation 16.014
|
55.89 ng/mL
Standard Deviation 20.890
|
71.02 ng/mL
Standard Deviation 38.025
|
Adverse Events
Cohorts 1-3: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1: TAK-906 50 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2: TAK-906 100 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3: TAK-906 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohorts 1-3: Placebo
n=6 participants at risk
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.
|
Cohort 1: TAK-906 50 mg
n=6 participants at risk
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.
|
Cohort 2: TAK-906 100 mg
n=6 participants at risk
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.
|
Cohort 3: TAK-906 10 mg
n=6 participants at risk
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.
|
|---|---|---|---|---|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER