Trial Outcomes & Findings for A Study of Vonoprazan in Adults With Helicobacter Pylori (NCT NCT04753437)
NCT ID: NCT04753437
Last Updated: 2023-08-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
Day 14: 0 to 12 hours after the morning dose
Results posted on
2023-08-31
Participant Flow
Participants took part in the study at 1 investigative site in China from 06 April 2021 to 05 November 2021.
Helicobacter pylori (H pylori) positive participants were enrolled and randomized to one of the two treatment groups to either receive quadruple therapy with bismuth, clarithromycin, amoxicillin, and vonoprazan versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and esomeprazole.
Participant milestones
| Measure |
Clarithromycin + Amoxicillin + Bismuth + Vonoprazan
Clarithromycin 500 milligram (mg), tablets, orally, twice daily (BID), along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and vonoprazan 20 mg, tablets, orally, BID on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Esomeprazole
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and esomeprazole 20 mg, tablets, orally, BID on Days 1 to 14.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Clarithromycin + Amoxicillin + Bismuth + Vonoprazan
Clarithromycin 500 milligram (mg), tablets, orally, twice daily (BID), along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and vonoprazan 20 mg, tablets, orally, BID on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Esomeprazole
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and esomeprazole 20 mg, tablets, orally, BID on Days 1 to 14.
|
|---|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
0
|
1
|
|
Overall Study
Liver Function Test Abnormalities
|
2
|
4
|
Baseline Characteristics
A Study of Vonoprazan in Adults With Helicobacter Pylori
Baseline characteristics by cohort
| Measure |
Clarithromycin + Amoxicillin + Bismuth + Vonoprazan
n=22 Participants
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and vonoprazan 20 mg, tablets, orally, BID on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Esomeprazole
n=22 Participants
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and esomeprazole 20 mg, tablets, orally, BID on Days 1 to 14.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 9.60 • n=5 Participants
|
31.6 years
STANDARD_DEVIATION 9.59 • n=7 Participants
|
33.1 years
STANDARD_DEVIATION 9.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 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
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 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
|
|
Region of Enrollment
China
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Height
|
167.2 cm
STANDARD_DEVIATION 6.58 • n=5 Participants
|
165.6 cm
STANDARD_DEVIATION 7.17 • n=7 Participants
|
166.4 cm
STANDARD_DEVIATION 6.85 • n=5 Participants
|
|
Weight
|
62.8 kg
STANDARD_DEVIATION 9.23 • n=5 Participants
|
63.2 kg
STANDARD_DEVIATION 8.23 • n=7 Participants
|
63.0 kg
STANDARD_DEVIATION 8.64 • n=5 Participants
|
|
Body Mass Index (BMI)
|
22.4 kg/m^2
STANDARD_DEVIATION 2.07 • n=5 Participants
|
23.1 kg/m^2
STANDARD_DEVIATION 3.09 • n=7 Participants
|
22.7 kg/m^2
STANDARD_DEVIATION 2.63 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14: 0 to 12 hours after the morning dosePopulation: Pharmacokinetic (PK) Analysis Set included participants who received the study drug (bismuth, vonoprazan or esomeprazole, clarithromycin, amoxicillin) and had at least 1 measurable plasma drug concentration after start of dosing without protocol violations or events with potential to affect the PK concentrations and who had completed minimum protocol procedures.
Outcome measures
| Measure |
Clarithromycin + Amoxicillin + Bismuth + Vonoprazan
n=20 Participants
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and vonoprazan 20 mg, tablets, orally, BID on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Esomeprazole
n=18 Participants
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and esomeprazole 20 mg, tablets, orally, BID on Days 1 to 14.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Bismuth
|
42.8 nanogram per milliliter (ng/mL)
Interval 32.6 to 56.2
|
32.9 nanogram per milliliter (ng/mL)
Interval 24.7 to 43.8
|
PRIMARY outcome
Timeframe: Day 14: 0 to 12 hours after the morning dosePopulation: PK Analysis set included participants who received the study drug (bismuth, vonoprazan or esomeprazole, clarithromycin, amoxicillin) and had at least 1 measurable plasma drug concentration after start of dosing without protocol violations or events with potential to affect the PK concentrations and who had completed minimum protocol procedures.
Outcome measures
| Measure |
Clarithromycin + Amoxicillin + Bismuth + Vonoprazan
n=20 Participants
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and vonoprazan 20 mg, tablets, orally, BID on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Esomeprazole
n=18 Participants
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and esomeprazole 20 mg, tablets, orally, BID on Days 1 to 14.
|
|---|---|---|
|
AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval τ for Bismuth
|
146 hour*nanogram/milliliter (h*ng/mL)
Interval 117.0 to 183.0
|
137 hour*nanogram/milliliter (h*ng/mL)
Interval 108.0 to 173.0
|
PRIMARY outcome
Timeframe: Day 14: 0 to 12 hours after the morning dosePopulation: PK Analysis Set included participants who received the study drug (bismuth, vonoprazan or esomeprazole, clarithromycin, amoxicillin) and had at least 1 measurable plasma drug concentration after start of dosing without protocol violations or events with potential to affect the PK concentrations and who had completed minimum protocol procedures.
Outcome measures
| Measure |
Clarithromycin + Amoxicillin + Bismuth + Vonoprazan
n=20 Participants
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and vonoprazan 20 mg, tablets, orally, BID on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Esomeprazole
n=18 Participants
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and esomeprazole 20 mg, tablets, orally, BID on Days 1 to 14.
|
|---|---|---|
|
Aeτ: Total Amount of Bismuth Excreted in Urine During a Dosing Interval τ for Bismuth
|
1026 micrograms (μg)
Standard Deviation 546.0
|
1037 micrograms (μg)
Standard Deviation 562.5
|
SECONDARY outcome
Timeframe: From the first dose of study drug up to Day 17Population: Safety Analysis Set included all participants who received at least 1 dose of study drug.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Clarithromycin + Amoxicillin + Bismuth + Vonoprazan
n=22 Participants
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and vonoprazan 20 mg, tablets, orally, BID on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Esomeprazole
n=22 Participants
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and esomeprazole 20 mg, tablets, orally, BID on Days 1 to 14.
|
|---|---|---|
|
Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE)
|
95.5 percentage of participants
|
95.5 percentage of participants
|
SECONDARY outcome
Timeframe: From the first dose of study drug up to Day 17Population: Safety Analysis Set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Clarithromycin + Amoxicillin + Bismuth + Vonoprazan
n=22 Participants
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and vonoprazan 20 mg, tablets, orally, BID on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Esomeprazole
n=22 Participants
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and esomeprazole 20 mg, tablets, orally, BID on Days 1 to 14.
|
|---|---|---|
|
Percentage of Participants Who Discontinued Study Drug Due to a Treatment-Emergent Adverse Event (TEAE)
|
9.1 percentage of participants
|
22.7 percentage of participants
|
Adverse Events
Clarithromycin + Amoxicillin + Bismuth + Vonoprazan
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Clarithromycin + Amoxicillin + Bismuth + Esomeprazole
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Clarithromycin + Amoxicillin + Bismuth + Vonoprazan
n=22 participants at risk
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and vonoprazan 20 mg, tablets, orally, BID on Days 1 to 14.
|
Clarithromycin + Amoxicillin + Bismuth + Esomeprazole
n=22 participants at risk
Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and esomeprazole 20 mg, tablets, orally, BID on Days 1 to 14.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
4.5%
1/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
40.9%
9/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
36.4%
8/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alpha hydroxybutyrate dehydrogenase increased
|
4.5%
1/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.6%
3/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Amylase increased
|
4.5%
1/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.6%
3/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
40.9%
9/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
31.8%
7/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.5%
1/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
2/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
2/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
4.5%
1/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
68.2%
15/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
81.8%
18/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Faeces discoloured
|
13.6%
3/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.5%
1/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.5%
1/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Hunger
|
4.5%
1/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.6%
3/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
13.6%
3/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
18.2%
4/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
22.7%
5/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.6%
3/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Thirst
|
9.1%
2/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.1%
2/22 • From the first dose of study drug up to Day 17
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any adverse event spontaneously reported by the participant or in response to an open question from study personnel or revealed by observation, physical examination, or other diagnostic procedures was recorded, irrespective of the causality with study drug. Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
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