Trial Outcomes & Findings for A Phase 1 Food Effect Study of TAK-536TCH Final Formulation Tablet (NCT NCT02348658)
NCT ID: NCT02348658
Last Updated: 2016-04-26
Results Overview
COMPLETED
PHASE1
12 participants
Day 1: predose and at multiple time points (up to 48 hours) postdose in each period
2016-04-26
Participant Flow
Participants took part in the study at 1 investigative site in Japan from 29 January 2015 to 11 March 2015.
Healthy adult male participants were enrolled in 1 of 2 treatment sequences in either of the Periods 1 or 2: Sequence A: TAK-536TCH (combination drug of TAK-536 \[azilsartan\], amlodipine besilate \[AML\], hydrochlorothiazide \[HTZ\]) Fasted in Period 1+ TAK-536TCH Fed in period 2; Sequence B: TAK-536TCH Fed in Period 1+ TAK-536TCH Fasted in Period 2.
Participant milestones
| Measure |
TAK-536TCH Fasted + TAK-536TCH Fed
TAK-536TCH (20 milligram \[mg\]/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 2.
|
TAK-536TCH Fed + TAK-536TCH Fasted
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 2.
|
|---|---|---|
|
Period 1 (7 Days)
STARTED
|
6
|
6
|
|
Period 1 (7 Days)
COMPLETED
|
6
|
6
|
|
Period 1 (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (22 Days)
STARTED
|
6
|
6
|
|
Washout Period (22 Days)
COMPLETED
|
6
|
6
|
|
Washout Period (22 Days)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (7 Days)
STARTED
|
6
|
6
|
|
Period 2 (7 Days)
COMPLETED
|
6
|
6
|
|
Period 2 (7 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1 Food Effect Study of TAK-536TCH Final Formulation Tablet
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participants
All participants who received either 1 of the two treatment sequences: Sequence 1: TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 2 or Sequence 2: TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 2.
|
|---|---|
|
Age, Continuous
|
22.2 years
STANDARD_DEVIATION 3.54 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
12 participants
n=5 Participants
|
|
Height
|
171.3 centimeter (cm)
STANDARD_DEVIATION 6.03 • n=5 Participants
|
|
Weight
|
61.18 kilogram (kg)
STANDARD_DEVIATION 5.548 • n=5 Participants
|
|
Body Mass Index (BMI)
|
20.85 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.499 • n=5 Participants
|
|
Smoking Classification
Never Smoked
|
6 participants
n=5 Participants
|
|
Smoking Classification
Current Smoker
|
3 participants
n=5 Participants
|
|
Smoking Classification
Ex-Smoker
|
3 participants
n=5 Participants
|
|
Alcohol Classification
Drinks a few Days per Month
|
7 participants
n=5 Participants
|
|
Alcohol Classification
Had Never Drunk
|
5 participants
n=5 Participants
|
|
Caffeine Classification
Caffeine Consumer
|
1 participants
n=5 Participants
|
|
Caffeine Classification
Caffeine Non-Consumer
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1: predose and at multiple time points (up to 48 hours) postdose in each periodPopulation: Pharmacokinetic (PK) analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
Outcome measures
| Measure |
TAK-536TCH Fasted
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ)
HCTZ
|
119.4 nanogram per milliliter (ng/mL)
Standard Deviation 30.481
|
101.6 nanogram per milliliter (ng/mL)
Standard Deviation 14.700
|
|
Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ)
TAK-536
|
1912.0 nanogram per milliliter (ng/mL)
Standard Deviation 253.39
|
1783.7 nanogram per milliliter (ng/mL)
Standard Deviation 318.16
|
|
Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ)
M-I
|
448.3 nanogram per milliliter (ng/mL)
Standard Deviation 143.36
|
455.3 nanogram per milliliter (ng/mL)
Standard Deviation 131.68
|
|
Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ)
M-II
|
453.5 nanogram per milliliter (ng/mL)
Standard Deviation 109.75
|
451.9 nanogram per milliliter (ng/mL)
Standard Deviation 101.18
|
PRIMARY outcome
Timeframe: Day 1: predose and at multiple time points (up to 120 hours) postdose in each periodPopulation: PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
Outcome measures
| Measure |
TAK-536TCH Fasted
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
Cmax: Maximum Plasma Concentration for Amlodipine Besilate (AML)
|
3.752 ng/mL
Standard Deviation 0.5124
|
3.668 ng/mL
Standard Deviation 0.6468
|
PRIMARY outcome
Timeframe: Day 1: predose and at multiple time points (up to 48 hours) postdose in each periodPopulation: PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
AUC(0-48) is a measure of the area under the plasma concentration time-curve from time 0 to 48 hours postdose.
Outcome measures
| Measure |
TAK-536TCH Fasted
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
TAK-536
|
14599.8 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 2254.31
|
13279.4 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 2889.22
|
|
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
M-I
|
3215.8 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 698.75
|
2693.8 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 706.41
|
|
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
M-II
|
9093.3 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 1711.69
|
8990.8 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 2310.99
|
|
AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
HCTZ
|
670.8 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 75.912
|
595.2 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 68.915
|
PRIMARY outcome
Timeframe: Day 1: predose and at multiple time points (up to 120 hours) postdose in each periodPopulation: PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
AUC(0-120) is a measure of the area under the plasma concentration time-curve from time 0 to 120 hours postdose.
Outcome measures
| Measure |
TAK-536TCH Fasted
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose in Each Period for AML
|
119.370 ng*hr/mL
Standard Deviation 27.7395
|
125.749 ng*hr/mL
Standard Deviation 26.9893
|
PRIMARY outcome
Timeframe: Day 1: predose and at multiple time points (up to 48 hours) postdose in each periodPopulation: PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
Outcome measures
| Measure |
TAK-536TCH Fasted
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
TAK-536
|
14599.8 ng*hr/mL
Standard Deviation 2254.31
|
13279.4 ng*hr/mL
Standard Deviation 2889.22
|
|
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
M-I
|
3215.8 ng*hr/mL
Standard Deviation 698.75
|
2693.8 ng*hr/mL
Standard Deviation 706.41
|
|
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
M-II
|
9093.3 ng*hr/mL
Standard Deviation 1711.69
|
8990.8 ng*hr/mL
Standard Deviation 2310.99
|
|
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
HCTZ
|
641.3 ng*hr/mL
Standard Deviation 87.752
|
556.4 ng*hr/mL
Standard Deviation 70.514
|
PRIMARY outcome
Timeframe: Day 1: predose and at multiple time points (up to 120 hours) postdose in each periodPopulation: PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
Outcome measures
| Measure |
TAK-536TCH Fasted
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for AML
|
119.370 ng*hr/mL
Standard Deviation 27.7395
|
125.749 ng*hr/mL
Standard Deviation 26.9893
|
PRIMARY outcome
Timeframe: Day 1: predose and at multiple time points (up to 48 hours) postdose in each periodPopulation: PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Outcome measures
| Measure |
TAK-536TCH Fasted
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
TAK-536
|
15077.4 ng*hr/mL
Standard Deviation 2433.01
|
13700.9 ng*hr/mL
Standard Deviation 3154.23
|
|
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
M-I
|
3271.3 ng*hr/mL
Standard Deviation 708.48
|
2755.1 ng*hr/mL
Standard Deviation 727.37
|
|
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
M-II
|
10496.0 ng*hr/mL
Standard Deviation 2221.49
|
10193.0 ng*hr/mL
Standard Deviation 2804.33
|
|
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ
HCTZ
|
673.5 ng*hr/mL
Standard Deviation 87.075
|
595.9 ng*hr/mL
Standard Deviation 69.847
|
PRIMARY outcome
Timeframe: Day 1: predose and at multiple time points (up to 120 hours) postdose in each periodPopulation: PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Outcome measures
| Measure |
TAK-536TCH Fasted
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for AML
|
132.941 ng*hr/mL
Standard Deviation 37.5121
|
140.484 ng*hr/mL
Standard Deviation 34.4402
|
PRIMARY outcome
Timeframe: Day 1: predose and at multiple time-points (up to 48 hours) postdose in each periodPopulation: PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
Urinary excretion ratio (percent \[%\] of dose) of TAK-536, its metabolite M-I, M-II and HCTZ in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.
Outcome measures
| Measure |
TAK-536TCH Fasted
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
Urinary Excretion Ratio of TAK-536, Its Metabolites (M-I and M-II) and HCTZ
TAK-536
|
13.682 percentage of dose
|
13.080 percentage of dose
|
|
Urinary Excretion Ratio of TAK-536, Its Metabolites (M-I and M-II) and HCTZ
M-I
|
0.076 percentage of dose
|
0.033 percentage of dose
|
|
Urinary Excretion Ratio of TAK-536, Its Metabolites (M-I and M-II) and HCTZ
M-II
|
19.275 percentage of dose
|
19.933 percentage of dose
|
|
Urinary Excretion Ratio of TAK-536, Its Metabolites (M-I and M-II) and HCTZ
HCTZ
|
73.742 percentage of dose
|
74.042 percentage of dose
|
PRIMARY outcome
Timeframe: Day 1: predose and at multiple time-points (up to 120 hours) postdose in each periodPopulation: PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.
Urinary excretion ratio (% of dose) of AML in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.
Outcome measures
| Measure |
TAK-536TCH Fasted
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
Urinary Excretion Ratio of AML
|
6.843 percentage of dose
|
7.328 percentage of dose
|
SECONDARY outcome
Timeframe: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )Population: Safety analysis set included all participants who received the study drug.
Outcome measures
| Measure |
TAK-536TCH Fasted
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )Population: Safety analysis set included all participants who received the study drug.
Outcome measures
| Measure |
TAK-536TCH Fasted
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
Number of Participants With TEAEs Related to Vital Signs
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )Population: Safety analysis set included all participants who received the study drug.
Outcome measures
| Measure |
TAK-536TCH Fasted
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
Number of Participants With TEAEs Related to Body Weight
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )Population: Safety analysis set included all participants who received the study drug.
Outcome measures
| Measure |
TAK-536TCH Fasted
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )Population: Safety analysis set included all participants who received the study drug.
Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measurement.
Outcome measures
| Measure |
TAK-536TCH Fasted
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 Participants
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
Number of Participants With Clinical Significant Findings in Electrocardiograms After Study Drug Administration
|
0 participants
|
0 participants
|
Adverse Events
TAK-536TCH Fasted
TAK-536TCH Fed
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAK-536TCH Fasted
n=12 participants at risk
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
|
TAK-536TCH Fed
n=12 participants at risk
TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
|
|---|---|---|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days for a serious adverse event after the last dose of study drug (14 days after Day 1 of Period 2).
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.
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days for a serious adverse event after the last dose of study drug (14 days after Day 1 of Period 2).
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 creatine phosphokinase increased
|
8.3%
1/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days for a serious adverse event after the last dose of study drug (14 days after Day 1 of Period 2).
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%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days for a serious adverse event after the last dose of study drug (14 days after Day 1 of Period 2).
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 The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER