Trial Outcomes & Findings for TAK-020 Relative Bioavailability and Food Effect Study in Healthy Participants (NCT NCT02723201)
NCT ID: NCT02723201
Last Updated: 2018-04-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Results posted on
2018-04-13
Participant Flow
Participants took part in the study at 1 investigative site in the United Kingdom from 28 April 2016 to 24 August 2016.
Healthy participants were enrolled in 3 part study to receive TAK-020. Part-1: relative bio-availability of solid formulations, Part-2: effect of food on co-crystal tablet(CCT) and Part-3: dose linearity of CCT. Part-3 was not conducted, as relative bioavailability of solid formulation was greater than(\>) 50% compared with oral solution of TAK-020.
Participant milestones
| Measure |
Part 1- TAK-020 17.5 mg: OS + CCT + SDT + IRT
TAK-020 17.5 milligram (mg), oral solution (OS), under fasted state, once on Day 1 of first intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, solid dispersion tablets (SDT), orally, under fasted state, once on Day 1 of third intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, immediate release tablets (IRT), orally, under fasted state, once on Day 1 of fourth intervention period.
|
Part 2- TAK-020 25 mg CCT: Fasted + Fed
TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fed, once on Day 1 of second intervention period.
|
Part 2- TAK-020 25 mg CCT: Fed + Fasted
TAK-020 25 mg, CCT, orally, under fed state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period.
|
|---|---|---|---|
|
First Intervention Period
STARTED
|
11
|
7
|
7
|
|
First Intervention Period
COMPLETED
|
11
|
7
|
7
|
|
First Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period 1
STARTED
|
11
|
7
|
7
|
|
Washout Period 1
COMPLETED
|
11
|
7
|
7
|
|
Washout Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Intervention Period
STARTED
|
11
|
7
|
7
|
|
Second Intervention Period
COMPLETED
|
9
|
7
|
7
|
|
Second Intervention Period
NOT COMPLETED
|
2
|
0
|
0
|
|
Washout Period 2
STARTED
|
9
|
0
|
0
|
|
Washout Period 2
COMPLETED
|
9
|
0
|
0
|
|
Washout Period 2
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Intervention Period
STARTED
|
9
|
0
|
0
|
|
Third Intervention Period
COMPLETED
|
9
|
0
|
0
|
|
Third Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period 3
STARTED
|
9
|
0
|
0
|
|
Washout Period 3
COMPLETED
|
9
|
0
|
0
|
|
Washout Period 3
NOT COMPLETED
|
0
|
0
|
0
|
|
Fourth Intervention Period
STARTED
|
9
|
0
|
0
|
|
Fourth Intervention Period
COMPLETED
|
9
|
0
|
0
|
|
Fourth Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1- TAK-020 17.5 mg: OS + CCT + SDT + IRT
TAK-020 17.5 milligram (mg), oral solution (OS), under fasted state, once on Day 1 of first intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, solid dispersion tablets (SDT), orally, under fasted state, once on Day 1 of third intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, immediate release tablets (IRT), orally, under fasted state, once on Day 1 of fourth intervention period.
|
Part 2- TAK-020 25 mg CCT: Fasted + Fed
TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fed, once on Day 1 of second intervention period.
|
Part 2- TAK-020 25 mg CCT: Fed + Fasted
TAK-020 25 mg, CCT, orally, under fed state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period.
|
|---|---|---|---|
|
Second Intervention Period
Protocol Violation
|
1
|
0
|
0
|
|
Second Intervention Period
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
Baseline measure was analyzed only for those participants who were current drinker and had alcohol consumption.
Baseline characteristics by cohort
| Measure |
Part 1: TAK-020 17.5 mg
n=11 Participants
TAK-020 17.5 mg, OS, under fasted state, once on Day 1 of first intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, SDT, orally, under fasted state, once on Day 1 of third intervention period; followed by 7 days washout period, followed by TAK-020 17.5 mg, IRT, orally, under fasted state, once on Day 1 of fourth intervention period.
|
Part 2- TAK-020 25 mg CCT: Fasted + Fed
n=7 Participants
TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fed, once on Day 1 of second intervention period.
|
Part 2- TAK-020 25 mg CCT: Fed + Fasted
n=7 Participants
TAK-020 25 mg, CCT, orally, under fed state, once on Day 1 of first intervention period, followed by 7 days of washout period, further followed by TAK-020 25 mg, CCT, orally, under fasted state, once on Day 1 of second intervention period.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 8.82 • n=11 Participants
|
31.1 years
STANDARD_DEVIATION 6.49 • n=7 Participants
|
38.9 years
STANDARD_DEVIATION 12.36 • n=7 Participants
|
39.3 years
STANDARD_DEVIATION 10.68 • n=25 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=11 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=11 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=11 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
25 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=11 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=11 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=25 Participants
|
|
Region of Enrollment
United Kingdom
|
11 Participants
n=11 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
25 Participants
n=25 Participants
|
|
Height
|
171.7 centimeter (cm)
STANDARD_DEVIATION 10.40 • n=11 Participants
|
172.3 centimeter (cm)
STANDARD_DEVIATION 7.36 • n=7 Participants
|
173.0 centimeter (cm)
STANDARD_DEVIATION 6.51 • n=7 Participants
|
172.2 centimeter (cm)
STANDARD_DEVIATION 8.34 • n=25 Participants
|
|
Weight
|
78.16 kilogram (kg)
STANDARD_DEVIATION 16.448 • n=11 Participants
|
74.26 kilogram (kg)
STANDARD_DEVIATION 11.454 • n=7 Participants
|
75.50 kilogram (kg)
STANDARD_DEVIATION 10.207 • n=7 Participants
|
76.32 kilogram (kg)
STANDARD_DEVIATION 13.212 • n=25 Participants
|
|
Body Mass Index (BMI)
|
26.23 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.140 • n=11 Participants
|
24.91 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.724 • n=7 Participants
|
25.19 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.884 • n=7 Participants
|
25.57 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.900 • n=25 Participants
|
|
Smoking Classification
Never smoked
|
10 Participants
n=11 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
21 Participants
n=25 Participants
|
|
Smoking Classification
Current smoker
|
0 Participants
n=11 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=25 Participants
|
|
Smoking Classification
Ex-smoker
|
1 Participants
n=11 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=25 Participants
|
|
Alcohol Classification
Never drinks
|
0 Participants
n=11 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=25 Participants
|
|
Alcohol Classification
Current drinker
|
10 Participants
n=11 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=25 Participants
|
|
Alcohol Classification
Ex-drinker
|
1 Participants
n=11 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=25 Participants
|
|
Caffeine/Xanthine Classification
Caffeine/xanthine consumption
|
10 Participants
n=11 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=25 Participants
|
|
Caffeine/Xanthine Classification
No caffeine/xanthine consumption
|
1 Participants
n=11 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=25 Participants
|
|
Female Reproductive Status
Surgically sterile
|
3 Participants
n=11 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=25 Participants
|
|
Female Reproductive Status
Female of childbearing potential
|
1 Participants
n=11 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=25 Participants
|
|
Female Reproductive Status
Not applicable (male participants)
|
7 Participants
n=11 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=25 Participants
|
|
Amount of Alcohol Consumed by Participant
Less than (<) 4 drinks per day
|
10 Participants
n=10 Participants • Baseline measure was analyzed only for those participants who were current drinker and had alcohol consumption.
|
6 Participants
n=6 Participants • Baseline measure was analyzed only for those participants who were current drinker and had alcohol consumption.
|
6 Participants
n=6 Participants • Baseline measure was analyzed only for those participants who were current drinker and had alcohol consumption.
|
22 Participants
n=22 Participants • Baseline measure was analyzed only for those participants who were current drinker and had alcohol consumption.
|
|
Amount of Alcohol Consumed by Participant
4 or more drinks per day
|
0 Participants
n=10 Participants • Baseline measure was analyzed only for those participants who were current drinker and had alcohol consumption.
|
0 Participants
n=6 Participants • Baseline measure was analyzed only for those participants who were current drinker and had alcohol consumption.
|
0 Participants
n=6 Participants • Baseline measure was analyzed only for those participants who were current drinker and had alcohol consumption.
|
0 Participants
n=22 Participants • Baseline measure was analyzed only for those participants who were current drinker and had alcohol consumption.
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: The pharmacokinetic (PK) set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Part 1: TAK-020 17.5 mg OS
n=11 Participants
TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg CCT
n=11 Participants
TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg SDT
n=9 Participants
TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg IRT
n=9 Participants
TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
|
Part 2: TAK-020 25 mg CCT Fasted
n=14 Participants
TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
|
Part 2: TAK-020 25 mg CCT Fed
n=14 Participants
TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
|
|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-020
|
104.182 nanogram per milliliter (ng/mL)
Standard Deviation 35.0658
|
44.800 nanogram per milliliter (ng/mL)
Standard Deviation 26.4189
|
139.522 nanogram per milliliter (ng/mL)
Standard Deviation 71.6739
|
6.012 nanogram per milliliter (ng/mL)
Standard Deviation 1.8606
|
63.314 nanogram per milliliter (ng/mL)
Standard Deviation 34.1699
|
40.629 nanogram per milliliter (ng/mL)
Standard Deviation 17.6750
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: The PK set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Part 1: TAK-020 17.5 mg OS
n=11 Participants
TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg CCT
n=11 Participants
TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg SDT
n=9 Participants
TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg IRT
n=9 Participants
TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
|
Part 2: TAK-020 25 mg CCT Fasted
n=14 Participants
TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
|
Part 2: TAK-020 25 mg CCT Fed
n=14 Participants
TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
|
|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020
|
0.530 hour
Interval 0.5 to 1.0
|
1.000 hour
Interval 0.5 to 2.0
|
0.750 hour
Interval 0.5 to 1.0
|
1.000 hour
Interval 0.75 to 6.0
|
1.000 hour
Interval 0.5 to 2.0
|
2.000 hour
Interval 0.75 to 4.03
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: The PK set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Part 1: TAK-020 17.5 mg OS
n=11 Participants
TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg CCT
n=10 Participants
TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg SDT
n=9 Participants
TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg IRT
n=8 Participants
TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
|
Part 2: TAK-020 25 mg CCT Fasted
n=13 Participants
TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
|
Part 2: TAK-020 25 mg CCT Fed
n=13 Participants
TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
|
|---|---|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-020
|
257.455 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 97.5416
|
164.485 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 72.4927
|
316.448 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 127.4409
|
32.783 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 18.5993
|
220.396 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 89.7255
|
185.935 nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 29.6651
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: The PK set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Part 1: TAK-020 17.5 mg OS
n=11 Participants
TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg CCT
n=10 Participants
TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg SDT
n=9 Participants
TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg IRT
n=8 Participants
TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
|
Part 2: TAK-020 25 mg CCT Fasted
n=13 Participants
TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
|
Part 2: TAK-020 25 mg CCT Fed
n=13 Participants
TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
|
|---|---|---|---|---|---|---|
|
Terminal Disposition Phase Half-life (T1/2z) in Plasma for TAK-020
|
4.695 hour
Standard Deviation 1.0781 • Interval 0.5 to 1.0
|
4.661 hour
Standard Deviation 1.4147 • Interval 0.5 to 2.0
|
3.976 hour
Standard Deviation 0.9787 • Interval 0.5 to 1.0
|
5.005 hour
Standard Deviation 2.8545 • Interval 0.75 to 6.0
|
6.183 hour
Standard Deviation 0.8914 • Interval 0.5 to 2.0
|
4.412 hour
Standard Deviation 1.2323 • Interval 0.75 to 4.03
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)Population: The safety analysis set included all participants who were enrolled and received 1 dose of study drug.
Outcome measures
| Measure |
Part 1: TAK-020 17.5 mg OS
n=11 Participants
TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg CCT
n=11 Participants
TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg SDT
n=9 Participants
TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg IRT
n=9 Participants
TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
|
Part 2: TAK-020 25 mg CCT Fasted
n=14 Participants
TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
|
Part 2: TAK-020 25 mg CCT Fed
n=14 Participants
TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Experience at Least One or More Treatment-emergent Adverse Event (TEAE)
|
1 participants
|
3 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 2Population: The safety analysis set included all participants who were enrolled and received 1 dose of study drug.
Outcome measures
| Measure |
Part 1: TAK-020 17.5 mg OS
n=11 Participants
TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg CCT
n=11 Participants
TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg SDT
n=9 Participants
TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg IRT
n=9 Participants
TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
|
Part 2: TAK-020 25 mg CCT Fasted
n=14 Participants
TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
|
Part 2: TAK-020 25 mg CCT Fed
n=14 Participants
TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose
Hematology
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose
Chemistry
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 2Population: The safety analysis set included all participants who were enrolled and received 1 dose of study drug.
Outcome measures
| Measure |
Part 1: TAK-020 17.5 mg OS
n=11 Participants
TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg CCT
n=11 Participants
TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg SDT
n=9 Participants
TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg IRT
n=9 Participants
TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
|
Part 2: TAK-020 25 mg CCT Fasted
n=14 Participants
TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
|
Part 2: TAK-020 25 mg CCT Fed
n=14 Participants
TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
|
0 participants
|
1 participants
|
2 participants
|
2 participants
|
6 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 2Population: The safety analysis set included all participants who were enrolled and received 1 dose of study drug.
Outcome measures
| Measure |
Part 1: TAK-020 17.5 mg OS
n=11 Participants
TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg CCT
n=11 Participants
TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg SDT
n=9 Participants
TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg IRT
n=9 Participants
TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
|
Part 2: TAK-020 25 mg CCT Fasted
n=14 Participants
TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
|
Part 2: TAK-020 25 mg CCT Fed
n=14 Participants
TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose
|
5 participants
|
5 participants
|
4 participants
|
4 participants
|
5 participants
|
3 participants
|
Adverse Events
Part 1: TAK-020 17.5 mg OS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: TAK-020 17.5 mg CCT
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: TAK-020 17.5 mg SDT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: TAK-020 17.5 mg IRT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: TAK-020 25 mg CCT Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: TAK-020 25 mg CCT Fed
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 |
Part 1: TAK-020 17.5 mg OS
n=11 participants at risk
TAK-020 17.5 mg, OS, once under fasted state on Day 1 of first intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg CCT
n=11 participants at risk
TAK-020 17.5 mg, CCT, orally under fasted state, once on Day 1 of second intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg SDT
n=9 participants at risk
TAK-020 17.5 mg, SDT, orally under fasted state, once on Day 1 of third intervention period. A washout period of 7 day was maintained between each intervention period.
|
Part 1: TAK-020 17.5 mg IRT
n=9 participants at risk
TAK-020 17.5 mg, IRT, orally under fasted state, once on Day 1 of fourth intervention period.
|
Part 2: TAK-020 25 mg CCT Fasted
n=14 participants at risk
TAK-020 25 mg, CCT, orally under fasted state, once on Day 1 of either first intervention period or second intervention period.
|
Part 2: TAK-020 25 mg CCT Fed
n=14 participants at risk
TAK-020 25 mg, CCT, orally under fed state, once on Day 1 of either first intervention period or second intervention period.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
9.1%
1/11 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
18.2%
2/11 • Number of events 2 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
9.1%
1/11 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
7.1%
1/14 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)
At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings.Any event spontaneously reported by participant/observed by investigator was recorded,irrespective of relation to study treatment.Number at risk included those participants who have actually received the mentioned intervention during study.
|
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