Trial Outcomes & Findings for A Study to Understand the Effect and Safety of the Study Medicine PF-07817883 in Adults Who Have Symptoms of COVID-19 But Are Not Hospitalized (NCT NCT05799495)
NCT ID: NCT05799495
Last Updated: 2024-10-09
Results Overview
Change from baseline in SARS-CoV-2 RNA level at Day 5 was analyzed using Mixed Effects Repeated Measures (MMRM) model with fixed effects including treatment, visit, visit by treatment interaction, and baseline viral load. Covariates included days from baseline since symptom onset (\<=3 versus \[vs.\] \>3 days), vaccination status (complete or partial vs. unvaccinated), baseline anti-N serology status and age at screening (years). Participants were excluded from the analysis if baseline viral load was less than 4\*log10 copies/milliliter, missing, or not detected.
COMPLETED
PHASE2
240 participants
Baseline (Day 1), Day 5
2024-10-09
Participant Flow
A total of 278 participants were screened, of which 37 failed screening and 1 participant was not randomized due to investigational product shortage at site. A total of 240 participants were randomized and assigned to study intervention.
Participant milestones
| Measure |
PF-07817883 100mg
Participants received PF-07817883, 100 milligrams (mg) orally every 12 hours (q12h) for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 300mg
Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 600mg
Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
Placebo
Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
|---|---|---|---|---|
|
Treatment (Up to 5 Days)
STARTED
|
40
|
40
|
80
|
80
|
|
Treatment (Up to 5 Days)
Treated
|
40
|
39
|
79
|
79
|
|
Treatment (Up to 5 Days)
COMPLETED
|
39
|
36
|
77
|
75
|
|
Treatment (Up to 5 Days)
NOT COMPLETED
|
1
|
4
|
3
|
5
|
|
Follow Up (Up to 4 Weeks)
STARTED
|
39
|
37
|
78
|
76
|
|
Follow Up (Up to 4 Weeks)
COMPLETED
|
39
|
37
|
77
|
76
|
|
Follow Up (Up to 4 Weeks)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
PF-07817883 100mg
Participants received PF-07817883, 100 milligrams (mg) orally every 12 hours (q12h) for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 300mg
Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 600mg
Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
Placebo
Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
|---|---|---|---|---|
|
Treatment (Up to 5 Days)
Adverse Event
|
0
|
1
|
1
|
0
|
|
Treatment (Up to 5 Days)
Non-compliance with study drug
|
0
|
0
|
0
|
1
|
|
Treatment (Up to 5 Days)
Other
|
0
|
1
|
0
|
0
|
|
Treatment (Up to 5 Days)
Withdrawal by Subject
|
1
|
1
|
1
|
3
|
|
Treatment (Up to 5 Days)
Randomized not treated
|
0
|
1
|
1
|
1
|
|
Follow Up (Up to 4 Weeks)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Understand the Effect and Safety of the Study Medicine PF-07817883 in Adults Who Have Symptoms of COVID-19 But Are Not Hospitalized
Baseline characteristics by cohort
| Measure |
PF-07817883 100mg
n=40 Participants
Participants received PF-07817883, 100 mg orally q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 300mg
n=39 Participants
Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 600mg
n=79 Participants
Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
Placebo
n=79 Participants
Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
Total
n=237 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.6 Years
STANDARD_DEVIATION 12.30 • n=5 Participants
|
41.9 Years
STANDARD_DEVIATION 11.31 • n=7 Participants
|
41.4 Years
STANDARD_DEVIATION 11.60 • n=5 Participants
|
41.5 Years
STANDARD_DEVIATION 12.97 • n=4 Participants
|
41.9 Years
STANDARD_DEVIATION 12.10 • n=21 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
147 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
193 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
203 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 5Population: The modified full analysis set (MFAS) included all participants in the full analysis set (FAS) who had SARS-CoV-2 RNA level greater than or equal to (\>=) 4\*log10 copies/mL at baseline. Participants were analyzed according to the study intervention to which they were randomized. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Change from baseline in SARS-CoV-2 RNA level at Day 5 was analyzed using Mixed Effects Repeated Measures (MMRM) model with fixed effects including treatment, visit, visit by treatment interaction, and baseline viral load. Covariates included days from baseline since symptom onset (\<=3 versus \[vs.\] \>3 days), vaccination status (complete or partial vs. unvaccinated), baseline anti-N serology status and age at screening (years). Participants were excluded from the analysis if baseline viral load was less than 4\*log10 copies/milliliter, missing, or not detected.
Outcome measures
| Measure |
PF-07817883 100mg
n=34 Participants
Participants received PF-07817883, 100 mg orally q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 300mg
n=24 Participants
Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 600mg
n=66 Participants
Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
Placebo
n=60 Participants
Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Logarithm Base 10 (Log10) Transformed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribo Nucleic Acid (RNA) Level on Day 5
|
-3.883 Log10 copies/milliliter
Interval -4.247 to -3.52
|
-4.015 Log10 copies/milliliter
Interval -4.452 to -3.578
|
-4.380 Log10 copies/milliliter
Interval -4.671 to -4.088
|
-3.213 Log10 copies/milliliter
Interval -3.517 to -2.908
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 3, Day 10 and Day 14Population: The MFAS included all participants in the FAS who had SARS-CoV-2 RNA level \>= 4\*log10 copies/mL at baseline. Participants were analyzed according to the study intervention to which they were randomized. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Change from baseline in SARS-CoV-2 RNA level at Day 3, Day 10 and Day 14 were analyzed using MMRM model with fixed effects including treatment, visit, visit by treatment interaction, and baseline viral load. Covariates included days from baseline since symptom onset (\<=3 vs. \>3 days), vaccination status (complete or partial vs. unvaccinated), baseline anti-N serology status and age at screening (years). Participants were excluded from the analysis if baseline viral load was less than 4\*log10 copies/milliliter, missing, or not detected.
Outcome measures
| Measure |
PF-07817883 100mg
n=35 Participants
Participants received PF-07817883, 100 mg orally q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 300mg
n=27 Participants
Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 600mg
n=70 Participants
Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
Placebo
n=63 Participants
Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Log10 Transformed SARS-CoV-2 RNA Level on Days 3, 10 and 14
Day 3
|
-2.006 Log10 copies/milliliter
Interval -2.371 to -1.641
|
-2.702 Log10 copies/milliliter
Interval -3.123 to -2.28
|
-2.546 Log10 copies/milliliter
Interval -2.818 to -2.274
|
-1.398 Log10 copies/milliliter
Interval -1.684 to -1.112
|
|
Change From Baseline in Log10 Transformed SARS-CoV-2 RNA Level on Days 3, 10 and 14
Day 10
|
-5.027 Log10 copies/milliliter
Interval -5.326 to -4.728
|
-5.085 Log10 copies/milliliter
Interval -5.423 to -4.748
|
-5.305 Log10 copies/milliliter
Interval -5.529 to -5.082
|
-5.091 Log10 copies/milliliter
Interval -5.332 to -4.851
|
|
Change From Baseline in Log10 Transformed SARS-CoV-2 RNA Level on Days 3, 10 and 14
Day 14
|
-5.682 Log10 copies/milliliter
Interval -5.913 to -5.451
|
-5.500 Log10 copies/milliliter
Interval -5.769 to -5.231
|
-5.826 Log10 copies/milliliter
Interval -6.009 to -5.643
|
-5.443 Log10 copies/milliliter
Interval -5.637 to -5.25
|
SECONDARY outcome
Timeframe: From start of study intervention up to 28 days after last dose of study intervention (up to 33 days)Population: The safety analysis set (SAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received.
An AE was any untoward medical occurrence in a study participant after administration of a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An adverse event is considered a treatment-emergent adverse event (TEAE) if the event started on or after the study medication start date and time. An SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions) or resulted in congenital anomaly/birth defect or was considered an important medical event.
Outcome measures
| Measure |
PF-07817883 100mg
n=40 Participants
Participants received PF-07817883, 100 mg orally q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 300mg
n=39 Participants
Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 600mg
n=79 Participants
Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
Placebo
n=79 Participants
Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
2 Participants
|
5 Participants
|
11 Participants
|
9 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study intervention up to 28 days after last dose of study intervention (up to 33 days)Population: The SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received.
An AE was any untoward medical occurrence in a study participant after administration of a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An adverse event is considered a treatment-emergent adverse event (TEAE) if the event started on or after the study medication start date and time. Participants with an AE record indicating the AE caused permanent discontinuation from the study were reported under discontinuations from study due to TEAEs. Permanent discontinuations from study intervention due to TEAEs included those participants who had an AE record that indicated that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study.
Outcome measures
| Measure |
PF-07817883 100mg
n=40 Participants
Participants received PF-07817883, 100 mg orally q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 300mg
n=39 Participants
Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 600mg
n=79 Participants
Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
Placebo
n=79 Participants
Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuations
Discontinuations from study due to TEAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuations
Permanent discontinuations from study intervention due to TEAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).Population: The SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
The following laboratory parameters were assessed according to pre-specified criteria for abnormalities: a) hematology; hemoglobin (gram per deciliter \[g/dL\]), (less than\[\<\]0.8\*lower limit of normal \[LLN\]), erythrocytes(10\^12/Liter \[L\])(\< 0.8\*LLN), lymphocytes(10\^9/L)(more than\[\>\]1.2\*upper limit of normal \[ULN\]), neutrophils(\> 1.2\*ULN and \< 0.8\*LLN), basophils(10\^9/L)(\> 1.2\*ULN) and eosinophils (10\^9/L)(\> 1.2\*ULN). b) clinical chemistry; bilirubin(mg/dL)(\> 1.5\*ULN), urea nitrogen(mg/dL)(\> 1.3\*ULN), creatinine(mg/dL)(\> 1.3\*ULN), potassium(milli equivalence per millilitre \[mEq/L\], (\< 0.9\*LLN and \> 1.1\*ULN), calcium (mg/dL)(\< 0.9\*LLN), bicarbonate(mEq/L)(\< 0.9\*LLN and \> 1.1\*ULN), glucose (mg/dL)(\> 1.5\*ULN), creatine kinase(units per litre \[U/L) (\> 2.0\* ULN), D-Dimer(nanogram per milliliter\[ng/mL\]), (\>1.5\*ULN) and c)urinalysis; bacteria (low power field \[LPF\]\>20). Number of participants with any laboratory abnormalities meeting pre-specified criteria are reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 100mg
n=39 Participants
Participants received PF-07817883, 100 mg orally q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 300mg
n=39 Participants
Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 600mg
n=78 Participants
Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
Placebo
n=77 Participants
Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
4 Participants
|
4 Participants
|
18 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).Population: The SAS included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Vital signs included blood pressure and pulse rate and were assessed with the participant in the supine or seated position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Pre-defined criteria for vital sign abnormalities was as systolic blood pressure (millimeter of mercury \[mmHg\]): value \< 90, change \>= 30 increase and change \>= 30 decrease, diastolic blood pressure (mmHg): value \<50; change \>= 20 increase and change \>= 20 decrease, pulse rate (beats per minute \[bpm\]): value \< 40 and value \> 120.
Outcome measures
| Measure |
PF-07817883 100mg
n=40 Participants
Participants received PF-07817883, 100 mg orally q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 300mg
n=39 Participants
Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 600mg
n=78 Participants
Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
Placebo
n=77 Participants
Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
|---|---|---|---|---|
|
Number of Participants Meeting Pre-defined Criteria of Vital Sign Abnormalities
Systolic blood pressure; value < 90 (mmHg)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Meeting Pre-defined Criteria of Vital Sign Abnormalities
Systolic blood pressure; change >= 30 (mmHg) increase
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Meeting Pre-defined Criteria of Vital Sign Abnormalities
Systolic blood pressure; change >= 30 (mmHg) decrease
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Meeting Pre-defined Criteria of Vital Sign Abnormalities
Diastolic blood pressure; value <50 (mmHg)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting Pre-defined Criteria of Vital Sign Abnormalities
Diastolic blood pressure; change >= 20 (mmHg) increase
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Meeting Pre-defined Criteria of Vital Sign Abnormalities
Diastolic blood pressure; change >= 20 (mmHg) decrease
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Meeting Pre-defined Criteria of Vital Sign Abnormalities
Pulse rate; value < 40 (bpm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting Pre-defined Criteria of Vital Sign Abnormalities
Pulse rate; value > 120 (bpm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline (Day 1) up to Day 10Population: The SAS included all participants randomly assigned to study intervention and who have taken at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Twelve lead ECGs were collected using an ECG machine that automatically calculated heart rate and measured PR interval, QT interval, and QT interval correct by Frederica formula (QTcF). ECG abnormalities included: PR interval (millisecond \[msec\]): value \>=280, change \>40 increase; QT interval aggregate (msec): value \> 500), QTcF interval (450 \< value =\< 480; 480 \< value =\< 500; value \> 500; 30 \< change \<= 60 increase and change \> 60 increase).
Outcome measures
| Measure |
PF-07817883 100mg
n=40 Participants
Participants received PF-07817883, 100 mg orally q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 300mg
n=39 Participants
Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 600mg
n=79 Participants
Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
Placebo
n=78 Participants
Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
|---|---|---|---|---|
|
Number of Participants Meeting Pre-defined Criteria For ECG Abnormalities
PR Interval, value >= 280 (msec)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting Pre-defined Criteria For ECG Abnormalities
PR Interval, change > 40 increase (msec)
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Meeting Pre-defined Criteria For ECG Abnormalities
QT Interval (msec) value >500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting Pre-defined Criteria For ECG Abnormalities
QTcF Interval, 450 < value =< 480 (msec)
|
1 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants Meeting Pre-defined Criteria For ECG Abnormalities
QTCF Interval, 480 < value =< 500 (msec)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting Pre-defined Criteria For ECG Abnormalities
QTCF Interval, value > 500 (msec)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting Pre-defined Criteria For ECG Abnormalities
QTCF Interval, 30 < change <= 60 increase (msec)
|
5 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants Meeting Pre-defined Criteria For ECG Abnormalities
QTCF Interval, change > 60 increase (msec)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
PF-07817883 100mg
PF-07817883 300mg
PF-07817883 600mg
Placebo
Serious adverse events
| Measure |
PF-07817883 100mg
n=40 participants at risk
Participants received PF-07817883, 100 mg orally q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 300mg
n=39 participants at risk
Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 600mg
n=79 participants at risk
Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
Placebo
n=79 participants at risk
Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/40 • From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.6%
1/39 • From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/79 • From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
0.00%
0/79 • From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
Other adverse events
| Measure |
PF-07817883 100mg
n=40 participants at risk
Participants received PF-07817883, 100 mg orally q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 300mg
n=39 participants at risk
Participants received PF-07817883, 300 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
PF-07817883 600mg
n=79 participants at risk
Participants received PF-07817883, 600 mg orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
Placebo
n=79 participants at risk
Participants received placebo orally every q12h for 5 days (10 doses total). Participants were followed up for 4 weeks.
|
|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/40 • From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.6%
1/39 • From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
2.5%
2/79 • From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
5.1%
4/79 • From start of study intervention up to 28 days after last dose of study intervention (up to 33 days).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
|
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