Trial Outcomes & Findings for A Study to Evaluate the Effect of High-Fat Meal on TAK-788 Pharmacokinetics (PK) in Healthy Adult Participants (NCT NCT04441255)
NCT ID: NCT04441255
Last Updated: 2021-09-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
Results posted on
2021-09-05
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 01 July 2020 to 10 August 2020.
Healthy participants were enrolled in 1 of the 2 treatment sequences of this 2-period cross-over study to receive mobocertinib (TAK-788) 160 milligram (mg), capsule, in fasted condition (Treatment A) or mobocertinib 160 mg, capsule, in fed condition (Treatment B).
Participant milestones
| Measure |
Mobocertinib 160 mg Fasted + Mobocertinib 160 mg Fed
Mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 1 under fasted conditions (Treatment A), followed by 10 days washout period, further followed by mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 2 under fed conditions (Treatment B).
|
Mobocertinib 160 mg Fed + Mobocertinib 160 mg Fasted
Mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 1 under fed conditions (Treatment B), followed by 10 days washout period, further followed by mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions (Treatment A).
|
|---|---|---|
|
Period 1 (1 Day)
STARTED
|
7
|
7
|
|
Period 1 (1 Day)
COMPLETED
|
7
|
7
|
|
Period 1 (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (10 Days)
STARTED
|
7
|
7
|
|
Washout Period (10 Days)
COMPLETED
|
7
|
7
|
|
Washout Period (10 Days)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (1 Day)
STARTED
|
7
|
7
|
|
Period 2 (1 Day)
COMPLETED
|
7
|
7
|
|
Period 2 (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Effect of High-Fat Meal on TAK-788 Pharmacokinetics (PK) in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Mobocertinib 160 mg Fasted + Mobocertinib 160 mg Fed
n=7 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 1 under fasted conditions (Treatment A), followed by 10 days washout period, further followed by mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 2 under fed conditions (Treatment B).
|
Mobocertinib 160 mg Fed + Mobocertinib 160 mg Fasted
n=7 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 1 under fed conditions (Treatment B), followed by 10 days washout period, further followed by mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions (Treatment A).
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.0 years
STANDARD_DEVIATION 9.61 • n=5 Participants
|
35.4 years
STANDARD_DEVIATION 9.14 • n=7 Participants
|
34.7 years
STANDARD_DEVIATION 9.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Weight
|
73.89 kilogram (kg)
STANDARD_DEVIATION 11.879 • n=5 Participants
|
76.70 kilogram (kg)
STANDARD_DEVIATION 16.416 • n=7 Participants
|
75.29 kilogram (kg)
STANDARD_DEVIATION 13.843 • n=5 Participants
|
|
Height
|
174.3 centimeter (cm)
STANDARD_DEVIATION 9.48 • n=5 Participants
|
175.6 centimeter (cm)
STANDARD_DEVIATION 13.50 • n=7 Participants
|
174.9 centimeter (cm)
STANDARD_DEVIATION 11.23 • n=5 Participants
|
|
Body Mass Index (BMI)
|
24.293 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.0143 • n=5 Participants
|
24.706 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.2743 • n=7 Participants
|
24.499 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.0311 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dosePopulation: The pharmacokinetic (PK) set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Mobocertinib 160 mg Fasted
n=13 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).
|
Mobocertinib 160 mg Fed
n=14 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).
|
|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib
|
6.01 hours
Interval 4.0 to 8.0
|
8.00 hours
Interval 4.01 to 12.0
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Mobocertinib 160 mg Fasted
n=13 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).
|
Mobocertinib 160 mg Fed
n=14 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Mobocertinib
|
56.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47.1
|
56.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40.9
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Mobocertinib 160 mg Fasted
n=13 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).
|
Mobocertinib 160 mg Fed
n=14 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).
|
|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib
|
1030 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 61.1
|
1230 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 59.5
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Mobocertinib 160 mg Fasted
n=13 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).
|
Mobocertinib 160 mg Fed
n=14 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).
|
|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib
|
1020 ng*hr/mL
Geometric Coefficient of Variation 61.4
|
1210 ng*hr/mL
Geometric Coefficient of Variation 60.0
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Mobocertinib 160 mg Fasted
n=13 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).
|
Mobocertinib 160 mg Fed
n=14 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).
|
|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Active Metabolites (AP32960 and AP32914) of Mobocertinib
AP32960
|
6.00 hours
Interval 4.0 to 8.02
|
8.00 hours
Interval 4.01 to 8.08
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Active Metabolites (AP32960 and AP32914) of Mobocertinib
AP32914
|
6.01 hours
Interval 4.0 to 8.02
|
8.00 hours
Interval 4.01 to 12.1
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Mobocertinib 160 mg Fasted
n=13 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).
|
Mobocertinib 160 mg Fed
n=14 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib
AP32960
|
31.1 ng/mL
Geometric Coefficient of Variation 22.3
|
27.7 ng/mL
Geometric Coefficient of Variation 22.5
|
|
Cmax: Maximum Observed Plasma Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib
AP32914
|
4.34 ng/mL
Geometric Coefficient of Variation 31.7
|
3.73 ng/mL
Geometric Coefficient of Variation 31.8
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here "number analyzed" were participants who were evaluable for the outcome measure at given categories.
Outcome measures
| Measure |
Mobocertinib 160 mg Fasted
n=13 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).
|
Mobocertinib 160 mg Fed
n=14 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).
|
|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Active Metabolites (AP32960 and AP32914) of Mobocertinib
AP32960
|
704 ng*hr/mL
Geometric Coefficient of Variation 31.3
|
731 ng*hr/mL
Geometric Coefficient of Variation 32.2
|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Active Metabolites (AP32960 and AP32914) of Mobocertinib
AP32914
|
79.4 ng*hr/mL
Geometric Coefficient of Variation 47.4
|
89.2 ng*hr/mL
Geometric Coefficient of Variation 50.6
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dosePopulation: The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.
Outcome measures
| Measure |
Mobocertinib 160 mg Fasted
n=13 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).
|
Mobocertinib 160 mg Fed
n=14 Participants
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).
|
|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib
AP32960
|
682 ng*hr/mL
Geometric Coefficient of Variation 31.9
|
709 ng*hr/mL
Geometric Coefficient of Variation 32.7
|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib
AP32914
|
69.2 ng*hr/mL
Geometric Coefficient of Variation 50.1
|
72.2 ng*hr/mL
Geometric Coefficient of Variation 53.9
|
Adverse Events
Mobocertinib 160 mg Fasted
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Mobocertinib 160 mg Fed
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mobocertinib 160 mg Fasted
n=14 participants at risk
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).
|
Mobocertinib 160 mg Fed
n=14 participants at risk
Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
4/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
21.4%
3/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
14.3%
2/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
General disorders
Feeling abnormal
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
General disorders
Feeling cold
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
General disorders
Pain
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
14.3%
2/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
|
Infections and infestations
Pustule
|
0.00%
0/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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.
|
7.1%
1/14 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 42).
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