Trial Outcomes & Findings for A Bioequivalence (BE) Study of TAK-438 Orally Disintegrating (OD) Tablet (NCT NCT03808493)
NCT ID: NCT03808493
Last Updated: 2020-04-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose
Results posted on
2020-04-07
Participant Flow
Participants took part in the study at 1 investigative site in Japan from 30 January 2019 to 12 March 2019.
Healthy Japanese male participants were enrolled in 1 of the 2 treatment sequences to receive TAK-438 OD 20 milligram (mg) or TAK-438 20 mg with or without water in Study 1, and TAK-438 OD 20 mg or TAK-438 20 mg with water in Study 2. Study was completed with Pilot study since results from interim analysis satisfied the criteria of bioequivalence.
Participant milestones
| Measure |
Pilot BE Study 1, Sequence A: TAK-438 OD 20 mg + TAK-438 20 mg
TAK-438 orally disintegrating (OD) 20 mg, tablet, orally without water under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 7 days, further followed by TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 2.
|
Pilot BE Study 1, Sequence B: TAK-438 20 mg + TAK-438 OD 20 mg
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 1 followed by a washout period of at least 7 days, further followed TAK-438 OD 20 mg, tablet, orally without water under fasted condition, once on Day 1 of Period 2.
|
Pilot BE Study 2, Sequence C: TAK-438 OD 20 mg + TAK-438 20 mg
TAK-438 OD 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 7 days, further followed by TAK-438 20 mg tablet, orally with water under fasted condition, once on Day 1 of Period 2.
|
Pilot BE Study 2, Sequence D: TAK-438 20 mg + TAK-438 OD 20 mg
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 7 days, further followed by TAK-438 OD 20 mg tablet, orally with water under fasted condition, once on Day 1 of Period 2.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
12
|
|
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 |
Pilot BE Study 1, Sequence A: TAK-438 OD 20 mg + TAK-438 20 mg
n=12 Participants
TAK-438 OD 20 mg, tablet, orally without water under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 7 days, further followed by TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 2.
|
Pilot BE Study 1, Sequence B: TAK-438 20 mg + TAK-438 OD 20 mg
n=12 Participants
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 1 followed by a washout period of at least 7 days, further followed TAK-438 OD 20 mg, tablet, orally without water under fasted condition, once on Day 1 of Period 2.
|
Pilot BE Study 2, Sequence C: TAK-438 OD 20 mg + TAK-438 20 mg
n=12 Participants
TAK-438 OD 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 7 days, further followed by TAK-438 20 mg tablet, orally with water under fasted condition, once on Day 1 of Period 2.
|
Pilot BE Study 2, Sequence D: TAK-438 20 mg + TAK-438 OD 20 mg
n=12 Participants
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of Period 1, followed by a washout period of at least 7 days, further followed by TAK-438 OD 20 mg tablet, orally with water under fasted condition, once on Day 1 of Period 2.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
22.1 years
STANDARD_DEVIATION 3.87 • n=12 Participants
|
26.0 years
STANDARD_DEVIATION 6.74 • n=12 Participants
|
26.5 years
STANDARD_DEVIATION 7.19 • n=12 Participants
|
26.0 years
STANDARD_DEVIATION 6.76 • n=12 Participants
|
25.1 years
STANDARD_DEVIATION 6.34 • n=48 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
48 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
48 Participants
n=48 Participants
|
|
Height
|
171.8 centimeter (cm)
STANDARD_DEVIATION 4.00 • n=12 Participants
|
170.0 centimeter (cm)
STANDARD_DEVIATION 6.52 • n=12 Participants
|
173.9 centimeter (cm)
STANDARD_DEVIATION 4.32 • n=12 Participants
|
172.2 centimeter (cm)
STANDARD_DEVIATION 6.94 • n=12 Participants
|
172.0 centimeter (cm)
STANDARD_DEVIATION 5.59 • n=48 Participants
|
|
Weight
|
59.83 kilogram (kg)
STANDARD_DEVIATION 4.672 • n=12 Participants
|
60.95 kilogram (kg)
STANDARD_DEVIATION 4.720 • n=12 Participants
|
63.29 kilogram (kg)
STANDARD_DEVIATION 4.860 • n=12 Participants
|
65.44 kilogram (kg)
STANDARD_DEVIATION 6.716 • n=12 Participants
|
62.38 kilogram (kg)
STANDARD_DEVIATION 5.586 • n=48 Participants
|
|
Body Mass Index (BMI)
|
20.28 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.817 • n=12 Participants
|
21.15 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.829 • n=12 Participants
|
20.94 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.781 • n=12 Participants
|
22.03 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.043 • n=12 Participants
|
21.10 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.718 • n=48 Participants
|
|
Caffeine Consumption
Had caffeine consumption
|
2 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
11 Participants
n=48 Participants
|
|
Caffeine Consumption
Had no caffeine consumption
|
10 Participants
n=12 Participants
|
11 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
37 Participants
n=48 Participants
|
|
Alcohol Consumption
Drank a few times per week
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
3 Participants
n=48 Participants
|
|
Alcohol Consumption
Drank a few times per month
|
6 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
14 Participants
n=48 Participants
|
|
Alcohol Consumption
Never drank
|
6 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
10 Participants
n=12 Participants
|
31 Participants
n=48 Participants
|
|
Smoking Classification
Never smoked
|
11 Participants
n=12 Participants
|
11 Participants
n=12 Participants
|
10 Participants
n=12 Participants
|
11 Participants
n=12 Participants
|
43 Participants
n=48 Participants
|
|
Smoking Classification
Former smoker
|
1 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
5 Participants
n=48 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dosePopulation: The pharmacokinetic (PK) analysis set was defined as all participants who received at least one dose of study drug, and whose PK data were evaluable.
Outcome measures
| Measure |
Pilot BE Study 1: TAK-438 OD 20 mg
n=24 Participants
TAK-438 OD 20 mg, tablet, orally without water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 1: TAK-438 20 mg
n=24 Participants
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 2: TAK-438 OD 20 mg
n=24 Participants
TAK-438 OD 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 2: TAK-438 20 mg
n=24 Participants
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Plasma Concentration for TAK-438 Free Base (TAK-438F)
|
190.2 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 67.984
|
194.3 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 67.693
|
201.6 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 81.799
|
201.2 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 75.813
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dosePopulation: The PK analysis set was defined as all participants who received at least one dose of study drug, and whose PK data were evaluable.
Outcome measures
| Measure |
Pilot BE Study 1: TAK-438 OD 20 mg
n=24 Participants
TAK-438 OD 20 mg, tablet, orally without water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 1: TAK-438 20 mg
n=24 Participants
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 2: TAK-438 OD 20 mg
n=24 Participants
TAK-438 OD 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 2: TAK-438 20 mg
n=24 Participants
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-438F
|
22.62 nanogram per milliliter (ng/mL)
Standard Deviation 7.8152
|
24.26 nanogram per milliliter (ng/mL)
Standard Deviation 8.0676
|
21.85 nanogram per milliliter (ng/mL)
Standard Deviation 7.7286
|
23.70 nanogram per milliliter (ng/mL)
Standard Deviation 8.5998
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dosePopulation: The PK analysis set was defined as all participants who received at least one dose of study drug, and whose PK data were evaluable.
Outcome measures
| Measure |
Pilot BE Study 1: TAK-438 OD 20 mg
n=24 Participants
TAK-438 OD 20 mg, tablet, orally without water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 1: TAK-438 20 mg
n=24 Participants
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 2: TAK-438 OD 20 mg
n=24 Participants
TAK-438 OD 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 2: TAK-438 20 mg
n=24 Participants
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F
|
192.5 h*ng/mL
Standard Deviation 68.755
|
196.4 h*ng/mL
Standard Deviation 68.436
|
204.3 h*ng/mL
Standard Deviation 83.014
|
203.6 h*ng/mL
Standard Deviation 77.630
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dosePopulation: The PK analysis set was defined as all participants who received at least one dose of study drug, and whose PK data were evaluable.
Outcome measures
| Measure |
Pilot BE Study 1: TAK-438 OD 20 mg
n=24 Participants
TAK-438 OD 20 mg, tablet, orally without water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 1: TAK-438 20 mg
n=24 Participants
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 2: TAK-438 OD 20 mg
n=24 Participants
TAK-438 OD 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 2: TAK-438 20 mg
n=24 Participants
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
|---|---|---|---|---|
|
Tmax: Time of First Occurrence of Maximum Plasma Concentration (Cmax) for TAK-438F
|
2.000 hour
Interval 1.0 to 4.0
|
1.750 hour
Interval 1.0 to 3.0
|
2.000 hour
Interval 1.0 to 4.0
|
2.000 hour
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dosePopulation: The PK analysis set was defined as all participants who received at least one dose of study drug, and whose PK data were evaluable.
Outcome measures
| Measure |
Pilot BE Study 1: TAK-438 OD 20 mg
n=24 Participants
TAK-438 OD 20 mg, tablet, orally without water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 1: TAK-438 20 mg
n=24 Participants
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 2: TAK-438 OD 20 mg
n=24 Participants
TAK-438 OD 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 2: TAK-438 20 mg
n=24 Participants
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
|---|---|---|---|---|
|
MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-438F
|
9.576 hour
Standard Deviation 1.1807
|
9.258 hour
Standard Deviation 0.91125
|
9.831 hour
Standard Deviation 1.3506
|
9.544 hour
Standard Deviation 1.4121
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dosePopulation: The PK analysis set was defined as all participants who received at least one dose of study drug, and whose PK data were evaluable.
Outcome measures
| Measure |
Pilot BE Study 1: TAK-438 OD 20 mg
n=24 Participants
TAK-438 OD 20 mg, tablet, orally without water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 1: TAK-438 20 mg
n=24 Participants
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 2: TAK-438 OD 20 mg
n=24 Participants
TAK-438 OD 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
Pilot BE Study 2: TAK-438 20 mg
n=24 Participants
TAK-438 20 mg, tablet, orally with water under fasted condition, once on Day 1 of either Period 1 or 2.
|
|---|---|---|---|---|
|
λz: Terminal Disposition Phase Rate Constant for TAK-438F
|
0.1014 per hour (1/hour)
Standard Deviation 0.014441
|
0.09903 per hour (1/hour)
Standard Deviation 0.011269
|
0.09807 per hour (1/hour)
Standard Deviation 0.013021
|
0.09989 per hour (1/hour)
Standard Deviation 0.016690
|
Adverse Events
Pilot BE Study 1: TAK-438 OD 20 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pilot BE Study 1: TAK-438 20 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pilot BE Study 2: TAK-438 OD 20 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pilot BE Study 2: TAK-438 20 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
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