Trial Outcomes & Findings for A Phase 1, Bio-equivalence Study of TAK-536 Pediatric Formulation (NCT NCT03042299)
NCT ID: NCT03042299
Last Updated: 2018-11-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)
Results posted on
2018-11-14
Participant Flow
Participants took part in the study at 1 investigative site in Japan from 10 February 2017 to 11 March 2017.
Healthy male participants were enrolled in 1 of the 2 treatment sequences of this 2-period cross-over study to receive TAK-536 10 milligram (mg) granules (pediatric formulation) or TAK-536 10 mg tablet (commercial formulation).
Participant milestones
| Measure |
TAK-536 Granules + TAK-536 Tablet
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.
|
TAK-536 Tablet + TAK-536 Granules
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.
|
|---|---|---|
|
Intervention Period 1 (6 Days)
STARTED
|
7
|
7
|
|
Intervention Period 1 (6 Days)
COMPLETED
|
7
|
7
|
|
Intervention Period 1 (6 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (at Least 6 Days)
STARTED
|
7
|
7
|
|
Washout Period (at Least 6 Days)
COMPLETED
|
7
|
7
|
|
Washout Period (at Least 6 Days)
NOT COMPLETED
|
0
|
0
|
|
Intervention Period 2 (6 Days)
STARTED
|
7
|
7
|
|
Intervention Period 2 (6 Days)
COMPLETED
|
7
|
7
|
|
Intervention Period 2 (6 Days)
NOT COMPLETED
|
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 |
TAK-536 Granules + TAK-536 Tablet
n=7 Participants
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.
|
TAK-536 Tablet + TAK-536 Granules
n=7 Participants
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.3 years
STANDARD_DEVIATION 0.95 • n=7 Participants
|
21.3 years
STANDARD_DEVIATION 1.38 • n=7 Participants
|
21.3 years
STANDARD_DEVIATION 1.14 • n=14 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=14 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=14 Participants
|
|
Height
|
167.7 centimeter (cm)
STANDARD_DEVIATION 3.64 • n=7 Participants
|
171.3 centimeter (cm)
STANDARD_DEVIATION 4.42 • n=7 Participants
|
169.5 centimeter (cm)
STANDARD_DEVIATION 4.31 • n=14 Participants
|
|
Weight
|
59.97 kilogram (kg)
STANDARD_DEVIATION 5.586 • n=7 Participants
|
60.49 kilogram (kg)
STANDARD_DEVIATION 6.838 • n=7 Participants
|
60.23 kilogram (kg)
STANDARD_DEVIATION 6.005 • n=14 Participants
|
|
Body Mass Index (BMI)
|
21.33 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.072 • n=7 Participants
|
20.61 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.143 • n=7 Participants
|
20.97 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.060 • n=14 Participants
|
|
Smoking classification
Never smoked
|
5 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=14 Participants
|
|
Smoking classification
Current smoker
|
1 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=14 Participants
|
|
Smoking classification
Ex-smoker
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=14 Participants
|
|
Alcohol classification
Drank a few times per week
|
1 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=14 Participants
|
|
Alcohol classification
Drank a few times per month
|
4 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=14 Participants
|
|
Alcohol classification
Never drank
|
2 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=14 Participants
|
|
Caffeine classification
Had caffeine consumption
|
1 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=14 Participants
|
|
Caffeine classification
Had no caffeine consumption
|
6 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)Population: The pharmacokinetic (PK) analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.
Outcome measures
| Measure |
TAK-536 10 mg Granules (Pediatric Formulation)
n=14 Participants
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
TAK-536 10 mg Tablet (Commercial Formulation)
n=14 Participants
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|
|
AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for TAK-536
|
6053.7 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 1119.60
|
6479.6 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 1008.00
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)Population: The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.
Outcome measures
| Measure |
TAK-536 10 mg Granules (Pediatric Formulation)
n=14 Participants
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
TAK-536 10 mg Tablet (Commercial Formulation)
n=14 Participants
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-536
|
803.3 nanogram per milliliter (ng/mL)
Standard Deviation 113.63
|
878.1 nanogram per milliliter (ng/mL)
Standard Deviation 117.88
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)Population: The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.
Outcome measures
| Measure |
TAK-536 10 mg Granules (Pediatric Formulation)
n=14 Participants
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
TAK-536 10 mg Tablet (Commercial Formulation)
n=14 Participants
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536
|
6187.4 h*ng/mL
Standard Deviation 1167.72
|
6627.4 h*ng/mL
Standard Deviation 1061.66
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)Population: The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.
Outcome measures
| Measure |
TAK-536 10 mg Granules (Pediatric Formulation)
n=14 Participants
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
TAK-536 10 mg Tablet (Commercial Formulation)
n=14 Participants
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536
|
1.89 hours
Standard Deviation 0.738
|
2.43 hours
Standard Deviation 0.958
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)Population: The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.
Outcome measures
| Measure |
TAK-536 10 mg Granules (Pediatric Formulation)
n=14 Participants
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
TAK-536 10 mg Tablet (Commercial Formulation)
n=14 Participants
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|
|
MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-536
|
9.781 hours
Standard Deviation 1.4010
|
10.11 hours
Standard Deviation 1.1873
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)Population: The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.
Outcome measures
| Measure |
TAK-536 10 mg Granules (Pediatric Formulation)
n=14 Participants
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
TAK-536 10 mg Tablet (Commercial Formulation)
n=14 Participants
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|
|
Terminal Disposition Phase Rate Constant (λz) for TAK-536
|
0.06866 liter per hour (L/h)
Standard Deviation 0.0046324
|
0.06862 liter per hour (L/h)
Standard Deviation 0.0077457
|
SECONDARY outcome
Timeframe: Baseline up to Day 6 of Intervention Period 2 (Day 18)Population: The safety analysis set included all participants who received 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 this treatment or study participation. An AE can therefore be any unfavorable and unintended sign (for example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study participation, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
TAK-536 10 mg Granules (Pediatric Formulation)
n=14 Participants
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
TAK-536 10 mg Tablet (Commercial Formulation)
n=14 Participants
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 6 of Intervention Period 2 (Day 18)Population: The safety analysis set included all the participants who received the study drug.
Outcome measures
| Measure |
TAK-536 10 mg Granules (Pediatric Formulation)
n=14 Participants
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
TAK-536 10 mg Tablet (Commercial Formulation)
n=14 Participants
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|
|
Number of Participants With TEAEs Related to Vital Signs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 6 of Intervention Period 2 (Day 18)Population: The safety analysis set included all the participants who received the study drug.
Outcome measures
| Measure |
TAK-536 10 mg Granules (Pediatric Formulation)
n=14 Participants
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
TAK-536 10 mg Tablet (Commercial Formulation)
n=14 Participants
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|
|
Number of Participants With TEAEs Related to Body Weight
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 6 of Intervention Period 2 (Day 18)Population: The safety analysis set included all the participants who received the study drug.
Outcome measures
| Measure |
TAK-536 10 mg Granules (Pediatric Formulation)
n=14 Participants
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
TAK-536 10 mg Tablet (Commercial Formulation)
n=14 Participants
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|
|
Number of Participants With TEAEs Related to Electrocardiograms (ECGs)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 6 of Intervention Period 2 (Day 18)Population: The safety analysis set included all the participants who received the study drug.
Outcome measures
| Measure |
TAK-536 10 mg Granules (Pediatric Formulation)
n=14 Participants
TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
TAK-536 10 mg Tablet (Commercial Formulation)
n=14 Participants
TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of either Intervention Period 1 or 2.
|
|---|---|---|
|
Number of Participants With TEAEs Related to Clinical Laboratory Tests
|
0 Participants
|
0 Participants
|
Adverse Events
TAK-536 10 mg Granules (Pediatric Formulation)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TAK-536 10 mg Tablet (Commercial Formulation)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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