Trial Outcomes & Findings for A Clinical Trial of the Study Medicine (PF-07081532) in People With Diabetes and Kidney Dysfunction (NCT NCT05510245)
NCT ID: NCT05510245
Last Updated: 2024-11-05
Results Overview
Plasma Cmax was observed directly from data.
TERMINATED
PHASE1
18 participants
Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1
2024-11-05
Participant Flow
The study was terminated due to the termination of clinical development of PF-07081532. As of the last participant last visit (LPLV) date (20 Jul 2023), a total of 18 participants were enrolled at 2 sites in the United States, and no participants without renal impairment were enrolled due to early study termination.
Participant milestones
| Measure |
Mild Renal Impairment
Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally.
|
Moderate Renal Impairment
Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally.
|
Severe Renal Impairment
Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
8
|
|
Overall Study
COMPLETED
|
4
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Mild Renal Impairment
Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally.
|
Moderate Renal Impairment
Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally.
|
Severe Renal Impairment
Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
A Clinical Trial of the Study Medicine (PF-07081532) in People With Diabetes and Kidney Dysfunction
Baseline characteristics by cohort
| Measure |
Mild Renal Impairment
n=5 Participants
Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally.
|
Moderate Renal Impairment
n=5 Participants
Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.0 Years
n=5 Participants
|
63.0 Years
n=7 Participants
|
66.5 Years
n=5 Participants
|
66.0 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
29.1 kg/m^2
STANDARD_DEVIATION 8.12 • n=5 Participants
|
31.2 kg/m^2
STANDARD_DEVIATION 6.89 • n=7 Participants
|
33.7 kg/m^2
STANDARD_DEVIATION 7.86 • n=5 Participants
|
31.7 kg/m^2
STANDARD_DEVIATION 7.49 • n=4 Participants
|
|
Body Surface Area (BSA)-Unnormalized Estimated Glomerular Filtration Rate (eGFR)
|
80.6 Milliliters per minute (mL/min)
STANDARD_DEVIATION 8.26 • n=5 Participants
|
48.7 Milliliters per minute (mL/min)
STANDARD_DEVIATION 6.43 • n=7 Participants
|
15.7 Milliliters per minute (mL/min)
STANDARD_DEVIATION 8.31 • n=5 Participants
|
NA Milliliters per minute (mL/min)
STANDARD_DEVIATION NA • n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1Population: Pharmacokinetic (PK) parameter set included all participants who received at least 1 dose of PF-07081532 and had at least 1 of the PK parameters of interest calculated.
Plasma Cmax was observed directly from data.
Outcome measures
| Measure |
Mild Renal Impairment
n=5 Participants
Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally.
|
Moderate Renal Impairment
n=5 Participants
Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally.
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment
|
2084 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
1823 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
1978 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1Population: PK parameter set included all participants who received at least 1 dose of PF-07081532 and had at least 1 of PK parameters of interest calculated.
Cmax,u was calculated as fu\*Cmax. Plasma Cmax was observed directly from data. fu was defined as the fraction of unbound drug in plasma, and was obtained from measurement of protein binding.
Outcome measures
| Measure |
Mild Renal Impairment
n=5 Participants
Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally.
|
Moderate Renal Impairment
n=5 Participants
Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally.
|
|---|---|---|---|
|
Unbound Cmax (Cmax,u) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment
|
0.6178 ng/mL
Geometric Coefficient of Variation 44
|
0.5895 ng/mL
Geometric Coefficient of Variation 17
|
0.8239 ng/mL
Geometric Coefficient of Variation 27
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1Population: PK parameter set included all participants, who received at least 1 dose of PF-07081532, had at least 1 of PK parameters of interest calculated. Number of Participants Analyzed represents the number of participants who were evaluable for this outcome measure.
AUCinf was calculated as AUClast + (Clast\*/kel). AUClast was defined as area under the plasma concentration-time profile from time 0 to the time last measurable concentration, and was calculated using linear/log trapezoidal method. Clast\* was defined as the predicted plasma concentration at the last quantifiable time point estimated from log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Mild Renal Impairment
n=4 Participants
Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally.
|
Moderate Renal Impairment
n=5 Participants
Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally.
|
Severe Renal Impairment
n=7 Participants
Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally.
|
|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment
|
59820 Nanograms*hours/milliliter (ng*h/mL)
Geometric Coefficient of Variation 41
|
45600 Nanograms*hours/milliliter (ng*h/mL)
Geometric Coefficient of Variation 21
|
43870 Nanograms*hours/milliliter (ng*h/mL)
Geometric Coefficient of Variation 33
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1Population: PK parameter set included all participants, who received at least 1 dose of PF-07081532, had at least 1 of PK parameters of interest calculated. Number of Participants Analyzed represents the number of participants who were evaluable for this outcome measure.
AUCinf,u was calculated as fu\*AUCinf. AUCinf was calculated as AUClast + (Clast\*/kel). AUClast was defined as area under the plasma concentration-time profile from time 0 to the time last measurable concentration, and was calculated using linear/log trapezoidal method. Clast\* was defined as the predicted plasma concentration at the last quantifiable time point estimated from log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. fu was the fraction of unbound drug in plasma, and was obtained from measurement of protein binding.
Outcome measures
| Measure |
Mild Renal Impairment
n=4 Participants
Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally.
|
Moderate Renal Impairment
n=5 Participants
Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally.
|
Severe Renal Impairment
n=7 Participants
Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally.
|
|---|---|---|---|
|
Unbound AUCinf (AUCinf,u) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment
|
17.51 ng*h/mL
Geometric Coefficient of Variation 56
|
14.75 ng*h/mL
Geometric Coefficient of Variation 31
|
18.44 ng*h/mL
Geometric Coefficient of Variation 35
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 hours post dose on Day 1Population: PK parameter set included all participants who received at least 1 dose of PF-07081532 and had at least 1 of PK parameters of interest calculated.
fu was the ratio of unbound drug concentration to the total drug concentration, and was obtained from measurement of protein binding.
Outcome measures
| Measure |
Mild Renal Impairment
n=5 Participants
Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally.
|
Moderate Renal Impairment
n=5 Participants
Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally.
|
|---|---|---|---|
|
Unbound Fraction (fu) for PF-07081532 Following a Single Oral Dose of PF-07081532 20 mg in Participants With Varying Degrees of Renal Impairment
|
0.0002964 Ratio
Geometric Coefficient of Variation 14
|
0.0003234 Ratio
Geometric Coefficient of Variation 15
|
0.0004163 Ratio
Geometric Coefficient of Variation 15
|
SECONDARY outcome
Timeframe: From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose)Population: Safety analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-emergent AEs (TEAEs) = AEs occurred after starting of study treatment and up to the end of study that were absent before treatment or that worsened relative to pretreatment state. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related AEs and SAEs were determined by the investigator. Severe=an event that prevents normal everyday activities.
Outcome measures
| Measure |
Mild Renal Impairment
n=5 Participants
Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally.
|
Moderate Renal Impairment
n=5 Participants
Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants With All-Causality TEAEs
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants With All-Causality SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants With All-Causality Severe TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants With Treatment-Related TEAEs
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants With Treatment-Related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants With Treatment-Related Severe TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 72 and 144 hours post dose on Day 1Population: Safety analysis set included all participants assigned to study intervention who took at least 1 dose of study intervention. Number of Participants Analyzed represents the total number of participants who were evaluable for this outcome measure. Number Analyzed for each lab parameter represents the number of participants who had at least 1 post dose measurement for the parameter.
Parameters analyzed for lab examination included hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin \[MCH\], MCH concentration, platelet count, white blood cell count, absolute \[Abs\] total neutrophils, Abs eosinophils, Abs monocytes, Abs basophils, Abs lymphocytes), chemistry (Scr, Scys, fasting plasma glucose, calcium, sodium, potassium, chloride, magnesium, phosphate, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl eGFR), urinalysis (pH, qualitative \[qual\] glucose, qual protein, qual blood, ketones, nitrites, leukocyte, esterase, urobilinogen, urine bili, microscopy). Lab parameters meeting the predefined criteria and with at least 1 occurrence from baseline up to end of study are reported. Baseline was defined as the last pre-dose measurement.
Outcome measures
| Measure |
Mild Renal Impairment
n=4 Participants
Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally.
|
Moderate Renal Impairment
n=5 Participants
Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally.
|
|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
Hematology-Hematocrit (%)<0.8*LLN
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Hematology-Hemoglobin (grams per deciliter [g/dL])<0.8*lower limit of normal (LLN)
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Hematology-Erythrocytes (10^12/Liter [L])<0.8*LLN
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Hematology-Eosinophils (10^9/L)>1.2* upper limit of normal (ULN)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Clinical Chemistry-Gamma Glutamyl Transferase (units [U]/L)>3.0*ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Clinical Chemistry-Urea Nitrogen (milligrams [mg] / dL)>1.3*ULN
|
1 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Clinical Chemistry-Creatinine (mg/dL)>1.3*ULN
|
0 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Clinical Chemistry-Urate (mg/dL)>1.2*ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Clinical Chemistry-Potassium (milliequivalents [mEq] / L)>1.1*ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Clinical Chemistry-Magnesium (mg/dL)<0.9*LLN
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Clinical Chemistry-Phosphate (mg/dL)<0.8*LLN
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Clinical Chemistry-Phosphate (mg/dL)>1.2*ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Clinical Chemistry-Bicarbonate (mEq/L)<0.9*LLN
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Clinical Chemistry-Fasting Glucose (mg/dL)>1.5*ULN
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Urinalysis-Urine Glucose Positive
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Urinalysis-Urine Protein Positive
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Urinalysis-Urine Hemoglobin Positive
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Urinalysis-Nitrite Positive
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Urinalysis-Leukocyte Esterase Positive
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At admission on Day -1, pre-dose, and 24, 72, and 144 hours post the dose on Day 1Population: Safety analysis set included all participants assigned to study intervention who took at least 1 dose of study intervention. Number of Participants Analyzed represents the total number of participants who were evaluable for this outcome measure. Number Analyzed for each lab parameter represents the number of participants who had at least 1 post dose measurement for the parameter.
Vital signs including single, seated blood pressure (BP) and pulse rate were measured with the participant's arm supported at the level of the heart, and recorded to the nearest mmHg, following a seated rest of ≥5 minutes. Same arm (preferably the dominant arm) was used for BP/pulse rate assessment throughout the study. Vital signs meeting the predefined criteria and with at least 1 occurrence from baseline up to end of study are reported. Baseline was defined as the last pre-dose measurement.
Outcome measures
| Measure |
Mild Renal Impairment
n=5 Participants
Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally.
|
Moderate Renal Impairment
n=5 Participants
Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally.
|
|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Pre-Defined Categorical Criteria
Systolic BP (mm Hg) Increase >=30 mm Hg
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-Defined Categorical Criteria
Diastolic BP (mm Hg) Increase >=20 mm Hg
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-Defined Categorical Criteria
Diastolic BP (mm Hg) Decrease >=20 mm Hg
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, and 144 hours post the dose on Day 1Population: Safety analysis set included all participants assigned to study intervention who took at least 1 dose of study intervention. Number of Participants Analyzed represents the total number of participants who were evaluable for this outcome measure. Number Analyzed for each lab parameter represents the number of participants who had at least 1 post dose measurement for the parameter.
Supine standard 12-lead ECGs utilizing limb leads (with a 10-second rhythm strip) were collected at times specified in the time frame using an ECG machine that automatically calculates the HR and measures PR interval, QT interval, QTcF, and QRS complex. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position. ECG data meeting the predefined criteria and with at least 1 occurrence from baseline up to end of study were reported. Baseline was defined as the last pre-dose measurement.
Outcome measures
| Measure |
Mild Renal Impairment
n=5 Participants
Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally.
|
Moderate Renal Impairment
n=5 Participants
Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally.
|
Severe Renal Impairment
n=8 Participants
Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally.
|
|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Defined Categorical Criteria
|
1 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
Mild Renal Impairment
Moderate Renal Impairment
Severe Renal Impairment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mild Renal Impairment
n=5 participants at risk
Participants with mild renal impairment received a single dose of PF-07081532 20 mg orally.
|
Moderate Renal Impairment
n=5 participants at risk
Participants with moderate renal impairment received a single dose of PF-07081532 20 mg orally.
|
Severe Renal Impairment
n=8 participants at risk
Participants with severe renal impairment received a single dose of PF-07081532 20 mg orally.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose).
Total number at risk below refers to the number of participants evaluable for AEs. All adverse events are reported, whether or not considered related to the study intervention.
|
20.0%
1/5 • From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose).
Total number at risk below refers to the number of participants evaluable for AEs. All adverse events are reported, whether or not considered related to the study intervention.
|
0.00%
0/8 • From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose).
Total number at risk below refers to the number of participants evaluable for AEs. All adverse events are reported, whether or not considered related to the study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose).
Total number at risk below refers to the number of participants evaluable for AEs. All adverse events are reported, whether or not considered related to the study intervention.
|
20.0%
1/5 • From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose).
Total number at risk below refers to the number of participants evaluable for AEs. All adverse events are reported, whether or not considered related to the study intervention.
|
0.00%
0/8 • From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose).
Total number at risk below refers to the number of participants evaluable for AEs. All adverse events are reported, whether or not considered related to the study intervention.
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose).
Total number at risk below refers to the number of participants evaluable for AEs. All adverse events are reported, whether or not considered related to the study intervention.
|
0.00%
0/5 • From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose).
Total number at risk below refers to the number of participants evaluable for AEs. All adverse events are reported, whether or not considered related to the study intervention.
|
12.5%
1/8 • From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose).
Total number at risk below refers to the number of participants evaluable for AEs. All adverse events are reported, whether or not considered related to the study intervention.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose).
Total number at risk below refers to the number of participants evaluable for AEs. All adverse events are reported, whether or not considered related to the study intervention.
|
20.0%
1/5 • From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose).
Total number at risk below refers to the number of participants evaluable for AEs. All adverse events are reported, whether or not considered related to the study intervention.
|
0.00%
0/8 • From time of administration of study treatment on Day 1 up to the end of the study (up to a maximum of 31 days post dose).
Total number at risk below refers to the number of participants evaluable for AEs. All adverse events are reported, whether or not considered related to the study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER