Trial Outcomes & Findings for A Study of TAK-227 in Healthy Adults (NCT NCT05818956)
NCT ID: NCT05818956
Last Updated: 2024-08-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Day 1 pre-dose and at multiple time points (up to 36 hours) post-dose
Results posted on
2024-08-06
Participant Flow
Participants took part in the study at single investigative site in the United States from 25 May 2023 to 26 June 2023.
Healthy participants were randomized in each of the 6 treatment sequences of this 3-period cross over study to receive a 50 milligram (mg) capsule of TAK-227 in the fasting state (Treatment A), fed predose state following a high-fat/high-calorie meal 30 minutes prior to dosing (Treatment B), or fed postdose state following a high-fat/high-calorie meal 30 minutes after dosing (Treatment C).
Participant milestones
| Measure |
Treatment Sequence 1: (Treatment A + Treatment B + Treatment C)
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 under fasting condition as Treatment A, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C. There was a washout period of not less than 4 days between each treatment period.
|
Treatment Sequence 2: (Treatment B + Treatment C + Treatment A)
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 under fasting condition as Treatment A . There was a washout period of not less than 4 days between each treatment period.
|
Treatment Sequence 3: (Treatment C + Treatment A + Treatment B)
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 under fasting condition as Treatment A, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B. There was a washout period of not less than 4 days between each treatment period.
|
Treatment Sequence 4: (Treatment A + Treatment C + Treatment B)
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 under fasting condition as Treatment A, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B. There was a washout period of not less than 4 days between each treatment period.
|
Treatment Sequence 5: (Treatment B + Treatment A + Treatment C)
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 under fasting condition as Treatment A, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C. There will be a washout period of not less than 4 days between each treatment period.
|
Treatment Sequence 6: (Treatment C + Treatment B + Treatment A)
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 under fasting condition as Treatment A. There will be a washout period of not less than 4 days between each treatment period.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1 (2 Days)
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Treatment Period 1 (2 Days)
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Treatment Period 1 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (4 Days)
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Washout Period 1 (4 Days)
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Washout Period 1 (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (2 Days)
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Treatment Period 2 (2 Days)
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Treatment Period 2 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (4 Days)
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Washout Period 2 (4 Days)
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Washout Period 2 (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (2 Days)
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Treatment Period 3 (2 Days)
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Treatment Period 3 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of TAK-227 in Healthy Adults
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1: (Treatment A + Treatment B + Treatment C)
n=4 Participants
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 under fasting condition as Treatment A, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C. There was a washout period of not less than 4 days between each treatment period.
|
Sequence 2: (Treatment B + Treatment C + Treatment A)
n=4 Participants
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 under fasting condition as Treatment A . There was a washout period of not less than 4 days between each treatment period.
|
Treatment Sequence 3: (Treatment C + Treatment A + Treatment B)
n=4 Participants
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 under fasting condition as Treatment A, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B. There was a washout period of not less than 4 days between each treatment period.
|
Treatment Sequence 4: (Treatment A + Treatment C + Treatment B)
n=4 Participants
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 under fasting condition as Treatment A, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B. There was a washout period of not less than 4 days between each treatment period.
|
Treatment Sequence 5: (Treatment B + Treatment A + Treatment C)
n=4 Participants
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 under fasting condition as Treatment A, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C. There will be a washout period of not less than 4 days between each treatment period.
|
Sequence 6: (Treatment C + Treatment B + Treatment A)
n=4 Participants
TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 1 administered with a high fat/high calorie meal 30 minutes after dosing as Treatment C, followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 2 administered with a high fat or high calorie meal 30 minutes prior to dosing as Treatment B, and further followed by TAK-227 50 mg, capsule, single oral dose on Day 1 of Treatment Period 3 under fasting condition as Treatment A. There will be a washout period of not less than 4 days between each treatment period.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 6.38 • n=99 Participants
|
43.0 years
STANDARD_DEVIATION 10.23 • n=107 Participants
|
39.5 years
STANDARD_DEVIATION 4.20 • n=206 Participants
|
42.8 years
STANDARD_DEVIATION 8.10 • n=7 Participants
|
43.0 years
STANDARD_DEVIATION 7.70 • n=31 Participants
|
36.5 years
STANDARD_DEVIATION 10.47 • n=30 Participants
|
42.3 years
STANDARD_DEVIATION 8.19 • n=3 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
11 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
13 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
21 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
24 Participants
n=3 Participants
|
|
Body Mass Index (BMI)
|
28.613 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.1689 • n=99 Participants
|
27.055 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.4694 • n=107 Participants
|
27.795 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.6085 • n=206 Participants
|
27.640 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.7334 • n=7 Participants
|
27.380 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.2070 • n=31 Participants
|
26.280 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.0572 • n=30 Participants
|
27.460 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.8896 • n=3 Participants
|
|
Height
|
164.5 centimeter (cm)
STANDARD_DEVIATION 8.43 • n=99 Participants
|
165.0 centimeter (cm)
STANDARD_DEVIATION 10.03 • n=107 Participants
|
162.3 centimeter (cm)
STANDARD_DEVIATION 12.71 • n=206 Participants
|
171.3 centimeter (cm)
STANDARD_DEVIATION 11.15 • n=7 Participants
|
169.8 centimeter (cm)
STANDARD_DEVIATION 15.65 • n=31 Participants
|
173.8 centimeter (cm)
STANDARD_DEVIATION 6.65 • n=30 Participants
|
167.8 centimeter (cm)
STANDARD_DEVIATION 10.72 • n=3 Participants
|
|
Weight
|
77.43 kilogram (kg)
STANDARD_DEVIATION 7.135 • n=99 Participants
|
74.18 kilogram (kg)
STANDARD_DEVIATION 15.436 • n=107 Participants
|
74.07 kilogram (kg)
STANDARD_DEVIATION 18.007 • n=206 Participants
|
80.78 kilogram (kg)
STANDARD_DEVIATION 5.038 • n=7 Participants
|
80.00 kilogram (kg)
STANDARD_DEVIATION 19.588 • n=31 Participants
|
79.33 kilogram (kg)
STANDARD_DEVIATION 4.640 • n=30 Participants
|
77.63 kilogram (kg)
STANDARD_DEVIATION 11.986 • n=3 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dosePopulation: The pharmacokinetic (PK) set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (for example, exposure to treatment, availability of measurements, and absence of major protocol violations) were included in the PK analyses.
Outcome measures
| Measure |
Treatment A: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 under fasted condition.
|
Treatment B: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes prior to dosing.
|
Treatment C: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes after dosing.
|
|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-227
|
464.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 89.8
|
190.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 50.6
|
370.0 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 102.6
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (for example, exposure to treatment, availability of measurements, and absence of major protocol violations) were included in the PK analyses.
Outcome measures
| Measure |
Treatment A: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 under fasted condition.
|
Treatment B: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes prior to dosing.
|
Treatment C: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes after dosing.
|
|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-227
|
1582 nanogram*hour per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 65.9
|
969.2 nanogram*hour per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 51.2
|
1056 nanogram*hour per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 53.0
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 36 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (for example, exposure to treatment, availability of measurements, and absence of major protocol violations) were included in the PK analyses. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Treatment A: TAK-227 50 mg
n=23 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 under fasted condition.
|
Treatment B: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes prior to dosing.
|
Treatment C: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes after dosing.
|
|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-227
|
1708 nanogram*hour per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 52.0
|
983.7 nanogram*hour per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 50.8
|
1070 nanogram*hour per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 51.8
|
SECONDARY outcome
Timeframe: From start of study drug administration up to 7 days after the last dose (up to Day 20)Population: The safety set included all participants who received at least one dose of the study drug and were included in the safety evaluations.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who had signed the informed consent form (ICF) to participate in a study; it did not necessarily have to have a causal relationship with the treatment. An SAE was any untoward medical occurrence that at any dose met one or more of the following criteria: resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Treatment A: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 under fasted condition.
|
Treatment B: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes prior to dosing.
|
Treatment C: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes after dosing.
|
|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration up to 7 days after the last dose (up to Day 20)Population: The safety set included all participants who received at least one dose of the study drug and were included in the safety evaluations.
Severity of a TEAEs were determined by following criteria: Mild: event that did not generally interfere with usual activities of daily living; Moderate: event that interfere with usual activities of daily living, causing discomfort, permanent risk of harm; Severe: AE that interrupt usual activities of daily living, significantly affects clinical status, or might require intensive therapeutic intervention.
Outcome measures
| Measure |
Treatment A: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 under fasted condition.
|
Treatment B: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes prior to dosing.
|
Treatment C: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes after dosing.
|
|---|---|---|---|
|
Number of Participants Based on Severity of TEAE
Mild
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Based on Severity of TEAE
Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Based on Severity of TEAE
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration up to 7 days after the last dose (up to Day 20)Population: The safety set included all participants who received at least one dose of the study drug and were included in the safety evaluations.
Causality of TEAEs to the study medication was assessed using the following categories: Related: An AE that followed a reasonable temporal sequence from administration of a drug (including the course after withdrawal of the drug), or for which a causal relationship was at least a reasonable possibility, that is, the relationship cannot be ruled out, although factors other than the drug, such as underlying diseases, complications, concomitant drugs and concurrent treatments, might also be responsible; Not Related: An AE that did not follow a reasonable temporal sequence from administration of a drug and/or that can reasonably be explained by other factors, such as underlying diseases, complications, concomitant medications and concurrent treatments.
Outcome measures
| Measure |
Treatment A: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 under fasted condition.
|
Treatment B: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes prior to dosing.
|
Treatment C: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes after dosing.
|
|---|---|---|---|
|
Number of Participants Based on Causality of TEAEs
Related TEAEs
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Based on Causality of TEAEs
Not Related TEAEs
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 13Population: The safety set included all participants who received at least one dose of the study drug and were included in the safety evaluations.
Vital signs included body temperature (oral or tympanic measurement), respiratory rate, blood pressure \[systolic blood pressure (SBP) and diastolic blood pressure (DBP)\], and pulse (beats per minute). The clinically significant change assessment was based on investigator's judgment. Number of participants with clinically significant change from baseline in vital signs values were reported.
Outcome measures
| Measure |
Treatment A: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 under fasted condition.
|
Treatment B: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes prior to dosing.
|
Treatment C: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes after dosing.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 13Population: The safety set included all participants who received at least one dose of the study drug and were included in the safety evaluations.
ECGs was performed with participants in a supine position. All ECG tracings were reviewed by the investigator or designee. Number of participants with clinically significant change from baseline in ECG values were reported.
Outcome measures
| Measure |
Treatment A: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 under fasted condition.
|
Treatment B: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes prior to dosing.
|
Treatment C: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes after dosing.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiograms (ECG) Values
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 13Population: The safety set included all participants who received at least one dose of the study drug and were included in the safety evaluations.
The clinically significant change assessment was based on investigator's judgment. Number of participants with clinically significant change from baseline in laboratory values (hematology, serum chemistry, and urinalysis) were reported.
Outcome measures
| Measure |
Treatment A: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 under fasted condition.
|
Treatment B: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes prior to dosing.
|
Treatment C: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes after dosing.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 13Population: The safety set included all participants who received at least one dose of the study drug and were included in the safety evaluations.
Physical examination included the following body systems: (1) respiratory system; (2) cardiovascular system; (3) nervous system (4) dermatologic system; and (5) gastrointestinal system. The clinically significant change assessment was based on investigator's judgment. Number of participants with clinically significant change from baseline in physical examination values were reported.
Outcome measures
| Measure |
Treatment A: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 under fasted condition.
|
Treatment B: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes prior to dosing.
|
Treatment C: TAK-227 50 mg
n=24 Participants
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes after dosing.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Physical Examination
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment A: TAK-227 50 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment B: TAK-227 50 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment C: TAK-227 50 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: TAK-227 50 mg
n=24 participants at risk
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 under fasted condition.
|
Treatment B: TAK-227 50 mg
n=24 participants at risk
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes prior to dosing.
|
Treatment C: TAK-227 50 mg
n=24 participants at risk
TAK-227 50 mg, capsule, orally, once on Day 1 of Treatment Periods 1, 2 and 3 with a high fat or high calorie meal 30 minutes after dosing.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
8.3%
2/24 • From start of study drug administration up to 7 days after the last dose (up to Day 20)
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%
0/24 • From start of study drug administration up to 7 days after the last dose (up to Day 20)
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%
0/24 • From start of study drug administration up to 7 days after the last dose (up to Day 20)
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