Trial Outcomes & Findings for A Study to Understand the Effect of Low-Fat and High-Fat Meals on the Medicine Called PF-07284890 in Healthy Adults (NCT NCT05349864)
NCT ID: NCT05349864
Last Updated: 2024-03-15
Results Overview
AUClast was defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). AUClast was determined by linear/Log trapezoidal method.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1 and 2
Results posted on
2024-03-15
Participant Flow
Participant milestones
| Measure |
PF-07284890 200 mg Fasted=>PF-07284890 200 mg Low-fat Meal=>PF-07284890 200 mg High-fat Meal
Participants in Sequence 1 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions (Treatment A) in Period 1, followed by a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions (Treatment B) in Period 2 after 5 days, and followed by a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3 after 5 days.
|
PF-07284890 200 mg Low-fat Meal=>PF-07284890 200 mg Fasted=>PF-07284890 200 mg High-fat Meal
Participants in Sequence 2 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions (Treatment B) in Period 1, followed by a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions (Treatment A) in Period 2 after 5 days, and followed by a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3 after 5 days.
|
|---|---|---|
|
Period 1 (5 Days)
STARTED
|
6
|
6
|
|
Period 1 (5 Days)
COMPLETED
|
6
|
6
|
|
Period 1 (5 Days)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (5 Days)
STARTED
|
6
|
6
|
|
Period 2 (5 Days)
COMPLETED
|
5
|
5
|
|
Period 2 (5 Days)
NOT COMPLETED
|
1
|
1
|
|
Period 3 (5 Days)
STARTED
|
5
|
5
|
|
Period 3 (5 Days)
COMPLETED
|
5
|
5
|
|
Period 3 (5 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
PF-07284890 200 mg Fasted=>PF-07284890 200 mg Low-fat Meal=>PF-07284890 200 mg High-fat Meal
Participants in Sequence 1 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions (Treatment A) in Period 1, followed by a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions (Treatment B) in Period 2 after 5 days, and followed by a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3 after 5 days.
|
PF-07284890 200 mg Low-fat Meal=>PF-07284890 200 mg Fasted=>PF-07284890 200 mg High-fat Meal
Participants in Sequence 2 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions (Treatment B) in Period 1, followed by a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions (Treatment A) in Period 2 after 5 days, and followed by a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3 after 5 days.
|
|---|---|---|
|
Period 2 (5 Days)
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study to Understand the Effect of Low-Fat and High-Fat Meals on the Medicine Called PF-07284890 in Healthy Adults
Baseline characteristics by cohort
| Measure |
Female
n=1 Participants
The Female participant was a healthy adult of non-childbearing potential between 18-65 years of age.
|
Male
n=11 Participants
Male participants were healthy adults between 18-65 years of age.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.0 Years
STANDARD_DEVIATION NA • n=5 Participants
|
42.5 Years
STANDARD_DEVIATION 12.23 • n=7 Participants
|
43.8 Years
STANDARD_DEVIATION 12.38 • n=5 Participants
|
|
Age, Customized
18-25
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
26-35
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
36-45
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Customized
>45
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1 and 2Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported.
AUClast was defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). AUClast was determined by linear/Log trapezoidal method.
Outcome measures
| Measure |
PF-07284890 200 mg Low-fat Meal (Test)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions as the test treatment (Treatment B) in either Period 1 or Period 2.
|
PF-07284890 200 mg Fasted (Reference)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions as the reference treatment (Treatment A) in either Period 1 or Period 2.
|
PF-07284890 200 mg High-fat Meal
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition
|
28270 Nanogram*Hour per Milliliter (ng*hr/mL)
Geometric Coefficient of Variation 25
|
23510 Nanogram*Hour per Milliliter (ng*hr/mL)
Geometric Coefficient of Variation 38
|
—
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1 and 2Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Overall number of participants analyzed signifies participants evaluable for this outcome measure.
AUCinf was defined as area under the plasma concentration-time curve from time zero extrapolated to infinity. AUCinf = AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Outcome measures
| Measure |
PF-07284890 200 mg Low-fat Meal (Test)
n=9 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions as the test treatment (Treatment B) in either Period 1 or Period 2.
|
PF-07284890 200 mg Fasted (Reference)
n=8 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions as the reference treatment (Treatment A) in either Period 1 or Period 2.
|
PF-07284890 200 mg High-fat Meal
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition
|
29380 ng*hr/mL
Geometric Coefficient of Variation 25
|
24600 ng*hr/mL
Geometric Coefficient of Variation 46
|
—
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1 and 2Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 concentration value could be reported.
Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data.
Outcome measures
| Measure |
PF-07284890 200 mg Low-fat Meal (Test)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions as the test treatment (Treatment B) in either Period 1 or Period 2.
|
PF-07284890 200 mg Fasted (Reference)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions as the reference treatment (Treatment A) in either Period 1 or Period 2.
|
PF-07284890 200 mg High-fat Meal
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of PF-07284890 in Plasma, Comparison of Low-Fat Meal With Fasted Condition
|
3460 Nanogram per Milliliter (ng/mL)
Geometric Coefficient of Variation 19
|
1672 Nanogram per Milliliter (ng/mL)
Geometric Coefficient of Variation 43
|
—
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported.
AUClast was defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). AUClast was determined by linear/Log trapezoidal method.
Outcome measures
| Measure |
PF-07284890 200 mg Low-fat Meal (Test)
n=10 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions as the test treatment (Treatment B) in either Period 1 or Period 2.
|
PF-07284890 200 mg Fasted (Reference)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions as the reference treatment (Treatment A) in either Period 1 or Period 2.
|
PF-07284890 200 mg High-fat Meal
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
|---|---|---|---|
|
AUClast of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition
|
31300 ng*hr/mL
Geometric Coefficient of Variation 21
|
23510 ng*hr/mL
Geometric Coefficient of Variation 38
|
—
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Overall number of participants analyzed signifies participants evaluable for this outcome measure.
AUCinf was defined as area under the plasma concentration-time curve from time zero extrapolated to infinity. AUCinf = AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Outcome measures
| Measure |
PF-07284890 200 mg Low-fat Meal (Test)
n=7 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions as the test treatment (Treatment B) in either Period 1 or Period 2.
|
PF-07284890 200 mg Fasted (Reference)
n=8 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions as the reference treatment (Treatment A) in either Period 1 or Period 2.
|
PF-07284890 200 mg High-fat Meal
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
|---|---|---|---|
|
AUCinf of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition
|
34130 ng*hr/mL
Geometric Coefficient of Variation 20
|
24600 ng*hr/mL
Geometric Coefficient of Variation 46
|
—
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 concentration value could be reported.
Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data.
Outcome measures
| Measure |
PF-07284890 200 mg Low-fat Meal (Test)
n=10 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions as the test treatment (Treatment B) in either Period 1 or Period 2.
|
PF-07284890 200 mg Fasted (Reference)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions as the reference treatment (Treatment A) in either Period 1 or Period 2.
|
PF-07284890 200 mg High-fat Meal
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
|---|---|---|---|
|
Cmax of PF-07284890 in Plasma, Comparison of High-Fat Meal With Fasted Condition
|
3892 ng/mL
Geometric Coefficient of Variation 22
|
1672 ng/mL
Geometric Coefficient of Variation 43
|
—
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported.
Tmax was defined as time to reach maximum observed plasma concentration. The determination method of Tmax was observing directly from data as time of first occurrence.
Outcome measures
| Measure |
PF-07284890 200 mg Low-fat Meal (Test)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions as the test treatment (Treatment B) in either Period 1 or Period 2.
|
PF-07284890 200 mg Fasted (Reference)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions as the reference treatment (Treatment A) in either Period 1 or Period 2.
|
PF-07284890 200 mg High-fat Meal
n=10 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
|---|---|---|---|
|
Time to Reach Cmax (Tmax) of PF-07284890 in Plasma
|
3.00 Hours (hr)
Interval 1.0 to 4.0
|
3.00 Hours (hr)
Interval 2.0 to 4.02
|
4.01 Hours (hr)
Interval 2.0 to 8.0
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Overall number of participants analyzed signifies participants evaluable for this outcome measure.
t1/2 was defined as the time required for the plasma concentration to decline by 50% during the elimination phase. t1/2 = loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.
Outcome measures
| Measure |
PF-07284890 200 mg Low-fat Meal (Test)
n=8 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions as the test treatment (Treatment B) in either Period 1 or Period 2.
|
PF-07284890 200 mg Fasted (Reference)
n=9 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions as the reference treatment (Treatment A) in either Period 1 or Period 2.
|
PF-07284890 200 mg High-fat Meal
n=7 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
|---|---|---|---|
|
Terminal Elimination Half-Life (t1/2) of PF-07284890 in Plasma
|
16.36 hr
Standard Deviation 4.1925
|
17.73 hr
Standard Deviation 5.2538
|
16.19 hr
Standard Deviation 4.4712
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Overall number of participants analyzed signifies participants evaluable for this outcome measure.
CL/F was defined as the apparent clearance. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL/F = dose/AUCinf, where AUCinf was the area under the plasma concentration-time curve from time zero extrapolated to infinity.
Outcome measures
| Measure |
PF-07284890 200 mg Low-fat Meal (Test)
n=8 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions as the test treatment (Treatment B) in either Period 1 or Period 2.
|
PF-07284890 200 mg Fasted (Reference)
n=9 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions as the reference treatment (Treatment A) in either Period 1 or Period 2.
|
PF-07284890 200 mg High-fat Meal
n=7 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
|---|---|---|---|
|
Apparent Clearance (CL/F) of PF-07284890 in Plasma
|
8.130 Liter per Hour (L/hr)
Geometric Coefficient of Variation 46
|
6.810 Liter per Hour (L/hr)
Geometric Coefficient of Variation 25
|
5.860 Liter per Hour (L/hr)
Geometric Coefficient of Variation 20
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose of PF-07284890 in Periods 1-3Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported. Overall number of participants analyzed signifies participants evaluable for this outcome measure.
Vz/F was defined as the apparent volume of distribution for extravascular dosing. Determination method of Vz/F was dose/(AUCinf\*kel), where kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.
Outcome measures
| Measure |
PF-07284890 200 mg Low-fat Meal (Test)
n=8 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions as the test treatment (Treatment B) in either Period 1 or Period 2.
|
PF-07284890 200 mg Fasted (Reference)
n=9 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions as the reference treatment (Treatment A) in either Period 1 or Period 2.
|
PF-07284890 200 mg High-fat Meal
n=7 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
|---|---|---|---|
|
Apparent Volume of Distribution for Extravascular Dosing (Vz/F) of PF-07284890 in Plasma
|
186.4 Liter (L)
Geometric Coefficient of Variation 36
|
168.5 Liter (L)
Geometric Coefficient of Variation 30
|
132.9 Liter (L)
Geometric Coefficient of Variation 12
|
SECONDARY outcome
Timeframe: From baseline up to 35 days after last dose of PF-07284890, up to 11 weeksPopulation: The analysis population included all participants assigned to study intervention and who took at least 1 dose of study intervention.
An AE was defined as 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. Any events occurring following start of treatment were considered as TEAEs.
Outcome measures
| Measure |
PF-07284890 200 mg Low-fat Meal (Test)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions as the test treatment (Treatment B) in either Period 1 or Period 2.
|
PF-07284890 200 mg Fasted (Reference)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions as the reference treatment (Treatment A) in either Period 1 or Period 2.
|
PF-07284890 200 mg High-fat Meal
n=10 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
|---|---|---|---|
|
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs)
|
5 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From baseline up to 35 days after last dose of PF-07284890, up to 11 weeksPopulation: The analysis population included all participants assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed = number of participants evaluable for laboratory abnormalities. Number Analyzed = total number of participants with at least one observation of the given laboratory test.
The hematological (Lymphocytes/Leukocytes, Neutrophils/Leukocytes and Monocytes/Leukocytes), clinical chemistry (Urate and Potassium) and urinalysis (Urine Hemoglobin, Leukocyte Esterase and Bacteria) safety tests were assessed against the pre-specified criteria. The assessment did not take into account whether each participant's baseline test result was within or outside the laboratory reference range for the particular laboratory parameter.
Outcome measures
| Measure |
PF-07284890 200 mg Low-fat Meal (Test)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions as the test treatment (Treatment B) in either Period 1 or Period 2.
|
PF-07284890 200 mg Fasted (Reference)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions as the reference treatment (Treatment A) in either Period 1 or Period 2.
|
PF-07284890 200 mg High-fat Meal
n=10 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities
Lymphocytes/Leukocytes >1.2 x upper limit of normal (ULN)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Neutrophils/Leukocytes <0.8 x lower limit of normal (LLN)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Monocytes/Leukocytes >1.2 x ULN
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Urate >1.2 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Potassium >1.1 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Urine Hemoglobin >=1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Leukocyte Esterase >=1
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Bacteria >20
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline up to 35 days after last dose of PF-07284890, up to 11 weeksPopulation: The analysis population included all participants assigned to study intervention and who took at least 1 dose of study intervention.
Supine systolic/diastolic blood pressure (BP) and pulse rate (PR) were measured and evaluated against pre-specified categorization criteria. The criteria included change of supine systolic/diastolic BP \>=30 mmHg increase or decrease, and value of supine PR \>120 beats per minute (bpm).
Outcome measures
| Measure |
PF-07284890 200 mg Low-fat Meal (Test)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions as the test treatment (Treatment B) in either Period 1 or Period 2.
|
PF-07284890 200 mg Fasted (Reference)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions as the reference treatment (Treatment A) in either Period 1 or Period 2.
|
PF-07284890 200 mg High-fat Meal
n=10 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
|---|---|---|---|
|
Number of Participants With Pre-Specified Categorization Criteria for Vital Signs
Change of Supine Systolic BP >=30 mmHg Increase
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-Specified Categorization Criteria for Vital Signs
Change of Supine Systolic BP >=30 mmHg Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-Specified Categorization Criteria for Vital Signs
Change of Supine Diastolic BP >=20 mmHg Increase
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-Specified Categorization Criteria for Vital Signs
Change of Supine Diastolic BP >=20 mmHg Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-Specified Categorization Criteria for Vital Signs
Value of Supine PR >120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline up to 35 days after last dose of PF-07284890, up to 11 weeksPopulation: The analysis population included all participants assigned to study intervention and who took at least 1 dose of study intervention.
Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate (HR) and measured PR interval, QT interval, corrected QT interval using Fridericia's formula (QTcF), and time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) complex. The number of participants with PR/QRS values and percent change from baseline, QT interval values, and QTcF values and increases from baseline in the pre-specified categories were summarized in this outcome measure (OM).
Outcome measures
| Measure |
PF-07284890 200 mg Low-fat Meal (Test)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions as the test treatment (Treatment B) in either Period 1 or Period 2.
|
PF-07284890 200 mg Fasted (Reference)
n=12 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions as the reference treatment (Treatment A) in either Period 1 or Period 2.
|
PF-07284890 200 mg High-fat Meal
n=10 Participants
Participants received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
|---|---|---|---|
|
Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs)
Value of QTcF >480 msec and <=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs)
Value of PR Interval >=300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs)
Percent Change of PR Interval >=25/50%
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs)
Value of QRS Duration >=140 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs)
Percent Change of QRS Duration >=50%
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs)
Value of QT Interval >=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs)
Value of QTcF >450 msec and <=480 msec
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs)
Value of QTcF >500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs)
Change of QTcF >=30 msec and <=60 msec
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Pre-Specified Categorization Criteria for 12-Lead Electrocardiograms (ECGs)
Change of QTcF >60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
PF-07284890 200 mg Fasted in Period 1 (Sequence 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-07284890 200 mg Low-fat Meal in Period 1 (Sequence 2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-07284890 200 mg Low-fat Meal in Period 2 (Sequence 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-07284890 200 mg Fasted in Period 2 (Sequence 2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-07284890 200 mg High-fat Meal in Period 3 (Sequence 1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-07284890 200 mg High-fat Meal in Period 3 (Sequence 2)
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 |
PF-07284890 200 mg Fasted in Period 1 (Sequence 1)
n=6 participants at risk
Participants in Sequence 1 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions (Treatment A) in Period 1.
|
PF-07284890 200 mg Low-fat Meal in Period 1 (Sequence 2)
n=6 participants at risk
Participants in Sequence 2 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions (Treatment B) in Period 1.
|
PF-07284890 200 mg Low-fat Meal in Period 2 (Sequence 1)
n=6 participants at risk
Participants in Sequence 1 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under low-fat meal fed conditions (Treatment B) in Period 2.
|
PF-07284890 200 mg Fasted in Period 2 (Sequence 2)
n=6 participants at risk
Participants in Sequence 2 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under fasted conditions (Treatment A) in Period 2.
|
PF-07284890 200 mg High-fat Meal in Period 3 (Sequence 1)
n=5 participants at risk
Participants in Sequence 1 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
PF-07284890 200 mg High-fat Meal in Period 3 (Sequence 2)
n=5 participants at risk
Participants in Sequence 2 received a single oral dose of PF-07284890 200 mg (2 × 100 mg tablets) under high-fat meal fed conditions (Treatment C) in Period 3.
|
|---|---|---|---|---|---|---|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Feeling hot
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Pain
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
16.7%
1/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Tension headache
|
16.7%
1/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/6 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
20.0%
1/5 • From baseline up to 35 days after last dose of PF-07284890, up to 11 weeks
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place