Trial Outcomes & Findings for A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants. (NCT NCT05857644)
NCT ID: NCT05857644
Last Updated: 2025-03-21
Results Overview
Cmax was the highest concentration observed directly from data
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6
Results posted on
2025-03-21
Participant Flow
Participants with varying degrees of hepatic function were enrolled in 4 groups
Participant milestones
| Measure |
No Hepatic Impairment
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Mild Hepatic Impairment
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Moderate Hepatic Impairment
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Severe Hepatic Impairment
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
4
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants.
Baseline characteristics by cohort
| Measure |
No Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Mild Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Moderate Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Severe Hepatic Impairment
n=4 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18-44 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Customized
45-64 years
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Age, Customized
≥65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6Population: All participants who received at least 1 dose of sisunatovir and had at least 1 of the pharmacokenetic parameters of interest calculated.
Cmax was the highest concentration observed directly from data
Outcome measures
| Measure |
No Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Mild Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Moderate Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Severe Hepatic Impairment
n=4 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
|---|---|---|---|---|
|
Plasma Maximum Concentration (Cmax) of Sisunatovir Following Administration of a Single Oral Dose
|
81.25 Nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 57
|
68.52 Nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 73
|
73.85 Nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 73
|
127.8 Nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
PRIMARY outcome
Timeframe: Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6Population: All participants who received at least 1 dose of sisunatovir and had at least 1 of the pharmacokenetic parameters of interest calculated.
AUClast was determined using linear/Log trapezoidal method
Outcome measures
| Measure |
No Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Mild Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Moderate Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Severe Hepatic Impairment
n=4 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sisunatovir Following Administration of a Single Oral Dose
|
891.6 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 37
|
732.6 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 70
|
1166 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 99
|
3437 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 20
|
PRIMARY outcome
Timeframe: Hours 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, and 120 postdose from Day 1 to Day 6Population: All participants who received at least 1 dose of sisunatovir and had at least 1 of the pharmacokenetic parameters of interest calculated.
AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminalphase rate constant.
Outcome measures
| Measure |
No Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Mild Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Moderate Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Severe Hepatic Impairment
n=4 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Sisunatovir Following Administration of a Single Oral Dose
|
922.6 ng*hr/mL
Geometric Coefficient of Variation 35
|
765.6 ng*hr/mL
Geometric Coefficient of Variation 68
|
1213 ng*hr/mL
Geometric Coefficient of Variation 95
|
3617 ng*hr/mL
Geometric Coefficient of Variation 19
|
SECONDARY outcome
Timeframe: Day -1 through follow-up (Day 29-36)Population: All participants assigned to study intervention and who took at least 1 dose of study intervention.
Adverse event (AE) was any untoward medical occurrence in the participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious AE was any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was considered to be an important medical event. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent. AEs included both serious and non-serious AEs.
Outcome measures
| Measure |
No Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Mild Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Moderate Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Severe Hepatic Impairment
n=4 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
|---|---|---|---|---|
|
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
All-causality TEAEs
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
Treatment-related TEAEs
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
Discontinuations from study due to TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day -1 and Day 6Population: All participants assigned to study intervention and who took at least 1 dose of study intervention, and who had at least one observation of the given laboratory test and had a laboratory abnormality meeting specified criteria while on study treatment or during lag time.
Laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute and percent total neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen/urea and creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin and total protein), urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy, urinary albumin to creatinine ratio and urinary protein to creatinine ratio) and other tests. Abnormality was determined by the investigator. Only lab abnormalities with at least 1 occurrence in participants are reported.
Outcome measures
| Measure |
No Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Mild Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Moderate Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Severe Hepatic Impairment
n=4 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
Erythrocytes <0.8 x lower limit of normal (LLN)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Ery. Mean Corpuscular Volume >1.1 x upper limit of normal (ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Ery. Mean Corpuscular Hemoglobin Concentration <0.9 x LLN
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Platelets <0.5 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Lymphocytes <0.8 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Neutrophils < 0.8 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Activated Partial Thromboplastin Time >1.1 x ULN
|
3 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Prothrombin Time >1.1 x ULN
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Prothrombin Intl. Normalized Ratio >1.1 x ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Bilirubin >1.5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Direct Bilirubin > 1.5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Indirect Bilirubin >1.5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Gamma Glutamyl Transferase >3.0 x ULN
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Albumin <0.8 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Potassium <0.9 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Bicarbonate <0.9 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Glucose - FASTING >1.5 x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
pH >8
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
URINE Glucose ≥1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Urobilinogen ≥1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Nitrite ≥1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day -1, Day 1, Day 2, and Day 6Population: All participants assigned to study intervention and who took at least 1 dose of study intervention.
Supine blood pressure and pulse rate were measured. Categorical classes for vital signs of potential clinical concerns were defined as followed: systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); diastolic blood pressure (DBP) \<50 mmHg; pulse rate \<40 beats per minute (bpm); pulse rate \>120 bpm, and increase from baseline in SBP ≥30 mmHg; decrease from baseline in SBP ≥30 mmHg; increase from baseline in DBP ≥20 mmHg; decrease from baseline in DBP ≥20 mmHg. The baseline measurement was the predose measurement on Day 1. Changes from baseline was defined as the change between the postdose and baseline measurements.
Outcome measures
| Measure |
No Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Mild Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Moderate Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Severe Hepatic Impairment
n=4 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
|---|---|---|---|---|
|
Number of Participants With Vital Signs Meeting Categorical Criteria
DBP: increase from baseline ≥20 mmHg
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Meeting Categorical Criteria
DBP: decrease from baseline ≥20 mmHg
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Meeting Categorical Criteria
SBP <90 mmHg
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Meeting Categorical Criteria
SBP: increase from baseline ≥30 mmHg
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day -1, Day 1, Day 2, and Day 6Population: All participants assigned to study intervention and who took at least 1 dose of study intervention.
Number of participants with ECG findings meeting the following criteria: time between the onset of atrial depolarization and onset of ventricular depolarization (PR interval) ≥300 msec; time from ECG Q-wave to the end of the S wave corresponding to ventricular depolarization (QRS duration) ≥140 msec; correct time from ECG Q-wave to the end of the T wave corresponding to electrical systole for heart rate using Fridericia's formula (QTcF interval): ≥450 to \<480 msec; QTcF interval ≥480 to \<500 msec; QTcF interval: ≥500 msec; PR interval percent change from baseline (≥25/50%): ≥25% if baseline \>200 msec or ≥ 50% if baseline ≤200 msec; QRS duration percent change from baseline ≥50%; QTcF interval change from baseline: \>30 to ≤60 msec; QTcF interval change from baseline \>60 msec. The baseline measurement was the predose measurement on Day 1. Changes from baseline was defined as the change between the postdose and baseline measurements.
Outcome measures
| Measure |
No Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Mild Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Moderate Hepatic Impairment
n=8 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Severe Hepatic Impairment
n=4 Participants
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
|---|---|---|---|---|
|
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
QTcF interval: ≥450 msec to <480 msec
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
QTcF interval: ≥480 msec to <500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
No Hepatic Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Mild Hepatic Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Hepatic Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Severe Hepatic Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
No Hepatic Impairment
n=8 participants at risk
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Mild Hepatic Impairment
n=8 participants at risk
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Moderate Hepatic Impairment
n=8 participants at risk
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
Severe Hepatic Impairment
n=4 participants at risk
Participants received an oral single dose of sisunatovir 200 mg (4 × 50 mg capsules) with the morning meal.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/8 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/8 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/4 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/8 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/8 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
25.0%
1/4 • Number of events 1 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/8 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/8 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/4 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/8 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
12.5%
1/8 • Number of events 1 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
0.00%
0/4 • Day -1 through follow-up (Day 29-36)
The time period for actively eliciting and collecting AEs and SAEs ("active collection period") for each participant beginned from the time the participant provides informed consent, which was obtained before before undergoing any study-related procedure and/or receiving study intervention, through and including a minimum of 28 calendar days, after the last administration of the investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60