Trial Outcomes & Findings for TAK-438 Bismuth Drug Interaction Study (NCT NCT02892409)
NCT ID: NCT02892409
Last Updated: 2019-01-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Baseline up to Day 17
Results posted on
2019-01-03
Participant Flow
Participants took part in the study at 1 investigative site in Korea from 05 September 2016 to 11 May 2017.
Participants with diagnosis of positive helicobacter pylori (HP) were enrolled in 1 of the 2 treatment groups to receive: Clarithromycin + Amoxicillin + Tripotassium Bismuth Dicitrate (Bismuth) + Lansoprazole twice daily or Clarithromycin + Amoxicillin + Bismuth + TAK-438 twice daily.
Participant milestones
| Measure |
Clarithromycin + Amoxicillin + Bismuth + TAK-438
Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole
Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Clarithromycin + Amoxicillin + Bismuth + TAK-438
Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole
Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
TAK-438 Bismuth Drug Interaction Study
Baseline characteristics by cohort
| Measure |
Clarithromycin + Amoxicillin + Bismuth + TAK-438
n=15 Participants
Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole
n=15 Participants
Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 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
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Continuous
|
32.8 years
STANDARD_DEVIATION 6.87 • n=5 Participants
|
33.3 years
STANDARD_DEVIATION 8.61 • n=7 Participants
|
33.1 years
STANDARD_DEVIATION 7.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Height
|
173.7 centimeter (cm)
STANDARD_DEVIATION 5.04 • n=5 Participants
|
168.9 centimeter (cm)
STANDARD_DEVIATION 5.14 • n=7 Participants
|
171.3 centimeter (cm)
STANDARD_DEVIATION 5.56 • n=5 Participants
|
|
Weight
|
72.41 kilogram (kg)
STANDARD_DEVIATION 5.028 • n=5 Participants
|
66.05 kilogram (kg)
STANDARD_DEVIATION 8.395 • n=7 Participants
|
69.23 kilogram (kg)
STANDARD_DEVIATION 7.528 • n=5 Participants
|
|
Body Mass Index (BMI)
|
24.03 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.795 • n=5 Participants
|
23.13 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.271 • n=7 Participants
|
23.58 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.064 • n=5 Participants
|
|
Smoking Classification
Never smoked
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Smoking Classification
Ex-smoker
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Alcohol Consumption
Drank a couple of days per week
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Alcohol Consumption
Drank a couple of days per month
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Alcohol Consumption
Never Drank
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Caffeine Consumption
Had caffeine consumption
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Caffeine Consumption
Had no caffeine consumption
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Cytochrome P450 2C19 (CYP2C19) Genotype
*1/*1
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Cytochrome P450 2C19 (CYP2C19) Genotype
*1/*2
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Cytochrome P450 2C19 (CYP2C19) Genotype
*1/*3
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Cytochrome P450 2C19 (CYP2C19) Genotype
*2/*2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Cytochrome P450 2C19 (CYP2C19) Genotype
*2/*3
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cytochrome P450 2C19 (CYP2C19) Genotype
*3/*3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 17Population: The safety analysis set included all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Clarithromycin + Amoxicillin + Bismuth + TAK-438
n=15 Participants
Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole
n=15 Participants
Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
|
|---|---|---|
|
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
|
53.3 percentage of participants
|
66.7 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 17Population: The safety analysis set included all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Clarithromycin + Amoxicillin + Bismuth + TAK-438
n=15 Participants
Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole
n=15 Participants
Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
|
|---|---|---|
|
Percentage of Participants Who Discontinue Due to an Adverse Event (AE)
|
6.7 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up Day 15Population: The safety analysis set included all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Clarithromycin + Amoxicillin + Bismuth + TAK-438
n=15 Participants
Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole
n=15 Participants
Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
|
|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose
Amylase (greater than [>] 2*upper limit of normal)
|
0.0 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose
Potassium (>6.0 millimole per liter [mmol/L])
|
0.0 percentage of participants
|
6.7 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 15Population: The safety analysis set included all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Clarithromycin + Amoxicillin + Bismuth + TAK-438
n=15 Participants
Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole
n=15 Participants
Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
|
|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Body temperature (less than [<] 35.6 celsius [C])
|
0.0 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Body temperature (>37.7 C)
|
6.7 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Systolic blood pressure(<85 millimeter of mercury)
|
6.7 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Diastolic blood pressure(<50millimeter of mercury)
|
6.7 percentage of participants
|
6.7 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 15Population: The safety analysis set included all participants who received at least one dose of study drug.
Outcome measures
| Measure |
Clarithromycin + Amoxicillin + Bismuth + TAK-438
n=15 Participants
Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole
n=15 Participants
Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
|
|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose
|
0.0 percentage of participants
|
6.7 percentage of participants
|
PRIMARY outcome
Timeframe: Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dosePopulation: The pharmacokinetic (PK) analysis set included all participants who received study drug, had sufficient plasma/urine concentration data to calculate at least one PK parameter, and had no significant protocol deviations.
Outcome measures
| Measure |
Clarithromycin + Amoxicillin + Bismuth + TAK-438
n=12 Participants
Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole
n=14 Participants
Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Bismuth
|
28.08 nanogram per milliliter (ng/mL)
Standard Deviation 11.691
|
30.14 nanogram per milliliter (ng/mL)
Standard Deviation 24.612
|
PRIMARY outcome
Timeframe: Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dosePopulation: The PK analysis set included all participants who received study drug, had sufficient plasma/urine concentration data to calculate at least one PK parameter, and had no significant protocol deviations.
Outcome measures
| Measure |
Clarithromycin + Amoxicillin + Bismuth + TAK-438
n=12 Participants
Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole
n=14 Participants
Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
|
|---|---|---|
|
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Bismuth
|
103.0 hours nanogram per milliliter (h*ng/mL)
Standard Deviation 37.498
|
111.1 hours nanogram per milliliter (h*ng/mL)
Standard Deviation 45.010
|
PRIMARY outcome
Timeframe: Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dosePopulation: The PK analysis set included all participants who received study drug, had sufficient plasma/urine concentration data to calculate at least one PK parameter, and had no significant protocol deviations. The PK analysis set where data was available at specified timepoints.
Outcome measures
| Measure |
Clarithromycin + Amoxicillin + Bismuth + TAK-438
n=12 Participants
Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole
n=13 Participants
Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
|
|---|---|---|
|
Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for Bismuth
|
497300 nanogram (ng)
Standard Deviation 202270
|
537600 nanogram (ng)
Standard Deviation 188340
|
Adverse Events
Clarithromycin + Amoxicillin + Bismuth + TAK-438
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Clarithromycin + Amoxicillin + Bismuth + TAK-438
n=15 participants at risk
Clarithromycin 500 milligram (mg), tablets, orally, twice daily, amoxicillin 1000 mg, capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and TAK-438 20 mg, tablets, orally, twice daily on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole
n=15 participants at risk
Clarithromycin 500 mg, tablets, orally, twice daily, amoxicillin 1000 mg capsules, orally, twice daily, bismuth 600 mg, tablets, orally, twice daily, and lansoprazole 30 mg, capsules, orally, twice daily on Days 1 to 14.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
|
Endocrine disorders
Hyperthyroidism
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
Faeces discoloured
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
13.3%
2/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
Dyspepsia
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
Infrequent bowel movements
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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 hot
|
13.3%
2/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
Catheter site erythema
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
Chest discomfort
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
Nasopharyngitis
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
Upper respiratory tract infection
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
Laceration
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
Dysgeusia
|
0.00%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
20.0%
3/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
Oropharyngeal pain
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
20.0%
3/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
Rhinorrhoea
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
Hyperhidrosis
|
20.0%
3/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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.
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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
Rash
|
6.7%
1/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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%
0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 17
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