Trial Outcomes & Findings for A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function (NCT NCT05098054)
NCT ID: NCT05098054
Last Updated: 2024-02-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
Results posted on
2024-02-02
Participant Flow
Participants took part in the study at 4 investigative sites in the United States from 29 October 2021 to 07 June 2022.
Participants diagnosed with moderate/mild hepatic impairment (HI) compared to matched healthy participants with normal hepatic function received single dose of soticlestat. 1 with severe HI, 8 with moderate HI, 8 with mild HI and overall 19 participants with normal hepatic function (12 matched to moderate HI and 12 matched to mild HI participants) were enrolled. Five of same participants with normal hepatic function served as matched to moderate and mild HI.
Participant milestones
| Measure |
Severe HI: Soticlestat 300 mg
Soticlestat 300 milligrams (mg), tablets, orally, once on Day 1 to participants with severe HI.
|
Moderate HI: Soticlestat 300 mg
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with moderate HI.
|
Mild HI: Soticlestat 300 mg
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with mild HI.
|
Normal Hepatic Function: Soticlestat 300 mg
Soticlestat 300 mg, tablets, orally, once on Day 1 to healthy participants.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
8
|
8
|
19
|
|
Overall Study
COMPLETED
|
1
|
8
|
8
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Here 'number analyzed' signifies that participant who were evaluable for this baseline measure.
Baseline characteristics by cohort
| Measure |
Severe HI: Soticlestat 300 mg
n=1 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to participants with severe HI.
|
Moderate HI: Soticlestat 300 mg
n=8 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with moderate HI.
|
Mild HI: Soticlestat 300 mg
n=8 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with mild HI.
|
Normal Hepatic Function: Soticlestat 300 mg
n=19 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to healthy participants.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION NA • n=1 Participants
|
59.4 years
STANDARD_DEVIATION 8.52 • n=8 Participants
|
56.4 years
STANDARD_DEVIATION 10.03 • n=8 Participants
|
58.2 years
STANDARD_DEVIATION 6.60 • n=19 Participants
|
58.3 years
STANDARD_DEVIATION 7.74 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
11 Participants
n=19 Participants
|
16 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
8 Participants
n=19 Participants
|
20 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=1 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
11 Participants
n=19 Participants
|
23 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=1 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
8 Participants
n=19 Participants
|
13 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=19 Participants
|
6 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=1 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
14 Participants
n=19 Participants
|
29 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=1 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
19 Participants
n=19 Participants
|
36 Participants
n=36 Participants
|
|
Body Mass Index (BMI)
|
26.460 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION NA • n=1 Participants
|
30.344 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.0131 • n=8 Participants
|
30.595 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.9193 • n=8 Participants
|
29.849 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.7734 • n=19 Participants
|
30.031 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.1868 • n=36 Participants
|
|
Height
|
159.0 centimeter (cm)
STANDARD_DEVIATION NA • n=1 Participants
|
166.1 centimeter (cm)
STANDARD_DEVIATION 11.72 • n=8 Participants
|
169.4 centimeter (cm)
STANDARD_DEVIATION 13.39 • n=8 Participants
|
167.5 centimeter (cm)
STANDARD_DEVIATION 9.02 • n=19 Participants
|
167.4 centimeter (cm)
STANDARD_DEVIATION 10.41 • n=36 Participants
|
|
Weight
|
66.90 kilogram (kg)
STANDARD_DEVIATION NA • n=1 Participants
|
83.80 kilogram (kg)
STANDARD_DEVIATION 14.289 • n=8 Participants
|
88.51 kilogram (kg)
STANDARD_DEVIATION 22.709 • n=8 Participants
|
84.07 kilogram (kg)
STANDARD_DEVIATION 11.124 • n=19 Participants
|
84.52 kilogram (kg)
STANDARD_DEVIATION 14.844 • n=36 Participants
|
|
Child-Pugh Score
|
10.00 score on scale
STANDARD_DEVIATION NA • n=1 Participants • Here 'number analyzed' signifies that participant who were evaluable for this baseline measure.
|
8.00 score on scale
STANDARD_DEVIATION 0.926 • n=8 Participants • Here 'number analyzed' signifies that participant who were evaluable for this baseline measure.
|
5.50 score on scale
STANDARD_DEVIATION 0.535 • n=8 Participants • Here 'number analyzed' signifies that participant who were evaluable for this baseline measure.
|
—
|
6.94 score on scale
STANDARD_DEVIATION 1.64 • n=17 Participants • Here 'number analyzed' signifies that participant who were evaluable for this baseline measure.
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dosePopulation: Pharmacokinetic (PK) Analysis Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) and were included in the statistical analyses. Five of the same participants with normal hepatic function served as matched to moderate and mild HI arms.
Outcome measures
| Measure |
Severe HI: Soticlestat 300 mg
n=1 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to participants with severe HI.
|
Moderate HI: Soticlestat 300 mg
n=8 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with moderate HI.
|
Mild HI: Soticlestat 300 mg
n=8 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with mild HI.
|
Normal Hepatic Function (Matched to Moderate HI): Soticlestat 300 mg
n=12 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to healthy participants with normal hepatic function matched to moderate HI.
|
Normal Hepatic Function (Matched to Mild HI): Soticlestat 300 mg
n=12 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to healthy participants with normal hepatic function matched to mild HI.
|
|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Soticlestat
|
3230 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
SD could not be calculated since only one participant was analyzed.
|
3666 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 130.9
|
1435 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 109.9
|
1705 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 81.9
|
986.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 58.0
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dosePopulation: PK Analysis Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) and were included in the statistical analyses. Five of the same participants with normal hepatic function served as matched to moderate and mild HI arms. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Severe HI: Soticlestat 300 mg
n=1 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to participants with severe HI.
|
Moderate HI: Soticlestat 300 mg
n=8 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with moderate HI.
|
Mild HI: Soticlestat 300 mg
n=6 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with mild HI.
|
Normal Hepatic Function (Matched to Moderate HI): Soticlestat 300 mg
n=10 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to healthy participants with normal hepatic function matched to moderate HI.
|
Normal Hepatic Function (Matched to Mild HI): Soticlestat 300 mg
n=11 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to healthy participants with normal hepatic function matched to mild HI.
|
|---|---|---|---|---|---|
|
AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Infinity for Soticlestat
|
2980 nanogram*hour per milliliter (ng•hr/mL)
Geometric Coefficient of Variation NA
SD could not be calculated since only one participant was analyzed.
|
5760 nanogram*hour per milliliter (ng•hr/mL)
Geometric Coefficient of Variation 263.0
|
1539 nanogram*hour per milliliter (ng•hr/mL)
Geometric Coefficient of Variation 67.1
|
1925 nanogram*hour per milliliter (ng•hr/mL)
Geometric Coefficient of Variation 53.3
|
1182 nanogram*hour per milliliter (ng•hr/mL)
Geometric Coefficient of Variation 46.3
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dosePopulation: PK Analysis Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) and were included in the statistical analyses. Five of the same participants with normal hepatic function served as matched to moderate and mild HI arms.
Outcome measures
| Measure |
Severe HI: Soticlestat 300 mg
n=1 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to participants with severe HI.
|
Moderate HI: Soticlestat 300 mg
n=8 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with moderate HI.
|
Mild HI: Soticlestat 300 mg
n=8 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with mild HI.
|
Normal Hepatic Function (Matched to Moderate HI): Soticlestat 300 mg
n=12 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to healthy participants with normal hepatic function matched to moderate HI.
|
Normal Hepatic Function (Matched to Mild HI): Soticlestat 300 mg
n=12 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to healthy participants with normal hepatic function matched to mild HI.
|
|---|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Soticlestat
|
2960 ng*hr/mL
Geometric Coefficient of Variation NA
SD could not be calculated since only one participant was analyzed.
|
5732 ng*hr/mL
Geometric Coefficient of Variation 266.1
|
1522 ng*hr/mL
Geometric Coefficient of Variation 55.5
|
1812 ng*hr/mL
Geometric Coefficient of Variation 58.1
|
1126 ng*hr/mL
Geometric Coefficient of Variation 46.2
|
SECONDARY outcome
Timeframe: From Day 1 up to 16 days after the last dose of study drug (up to Day 17)Population: Safety analysis set included all participants who received the dose of soticlestat.
An Adverse Event (AE) was 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 (example, 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 was defined as an AE that started or worsened at the time of or after dosing of study drug.
Outcome measures
| Measure |
Severe HI: Soticlestat 300 mg
n=1 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to participants with severe HI.
|
Moderate HI: Soticlestat 300 mg
n=8 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with moderate HI.
|
Mild HI: Soticlestat 300 mg
n=8 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with mild HI.
|
Normal Hepatic Function (Matched to Moderate HI): Soticlestat 300 mg
n=19 Participants
Soticlestat 300 mg, tablets, orally, once on Day 1 to healthy participants with normal hepatic function matched to moderate HI.
|
Normal Hepatic Function (Matched to Mild HI): Soticlestat 300 mg
Soticlestat 300 mg, tablets, orally, once on Day 1 to healthy participants with normal hepatic function matched to mild HI.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
Adverse Events
Severe HI: Soticlestat 300 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Moderate HI: Soticlestat 300 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Mild HI: Soticlestat 300 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Normal Hepatic Function: Soticlestat 300 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Severe HI: Soticlestat 300 mg
n=1 participants at risk
Soticlestat 300 mg, tablets, orally, once on Day 1 to participants with severe HI.
|
Moderate HI: Soticlestat 300 mg
n=8 participants at risk
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with moderate HI.
|
Mild HI: Soticlestat 300 mg
n=8 participants at risk
Soticlestat 300 mg, tablets, orally, once on Day 1 to participant with mild HI.
|
Normal Hepatic Function: Soticlestat 300 mg
n=19 participants at risk
Soticlestat 300 mg, tablets, orally, once on Day 1 to healthy participants.
|
|---|---|---|---|---|
|
Investigations
Alpha-1 acid glycoprotein increased
|
0.00%
0/1 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 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
Cough
|
100.0%
1/1 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 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
Epistaxis
|
0.00%
0/1 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • TEAEs were adverse events that started from Day 1 up to 16 days after the last 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 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