Trial Outcomes & Findings for A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult Volunteers (NCT NCT06122194)

NCT ID: NCT06122194

Last Updated: 2025-01-30

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period

Results posted on

2025-01-30

Participant Flow

A total of 12 participants were enrolled and randomized in this study to 1 of the 4 study treatment sequences.

Participant milestones

Participant milestones
Measure	Treatment Sequence 1: A Then B Then C Then D Participants were randomized to receive a single oral dose of treatment A on Day 1 of Period 1; followed by a single oral dose of treatment B on Day 1 of Period 2; followed by a single oral dose of treatment C on Day 1 of Period 3; followed by a single oral dose of treatment D on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 milligram (mg) tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.	Treatment Sequence 2: B Then D Then A Then C Participants were randomized to receive a single oral dose of treatment B on Day 1 of Period 1; followed by a single oral dose of treatment D on Day 1 of Period 2; followed by a single oral dose of treatment A on Day 1 of Period 3; followed by a single oral dose of treatment C on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.	Treatment Sequence 3: C Then A Then D Then B Participants were randomized to receive a single oral dose of treatment C on Day 1 of Period 1; followed by a single oral dose of treatment A on Day 1 of Period 2; followed by a single oral dose of treatment D on Day 1 of Period 3; followed by a single oral dose of treatment B on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.	Treatment Sequence 4: D Then C Then B Then A Participants were randomized to receive a single oral dose of treatment D on Day 1 of Period 1; followed by a single oral dose of treatment C on Day 1 of Period 2; followed by a single oral dose of treatment B on Day 1 of Period 3; followed by a single oral dose of treatment A on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.
Treatment Period 1 (3 Days) STARTED	3	3	3	3
Treatment Period 1 (3 Days) Treated	3	3	3	3
Treatment Period 1 (3 Days) COMPLETED	3	3	2	3
Treatment Period 1 (3 Days) NOT COMPLETED	0	0	1	0
Treatment Period 2 (3 Days) STARTED	3	3	2	3
Treatment Period 2 (3 Days) COMPLETED	3	3	2	3
Treatment Period 2 (3 Days) NOT COMPLETED	0	0	0	0
Treatment Period 3 (3 Days) STARTED	3	3	2	3
Treatment Period 3 (3 Days) COMPLETED	3	3	2	3
Treatment Period 3 (3 Days) NOT COMPLETED	0	0	0	0
Treatment Period 4 (3 Days) STARTED	3	3	2	3
Treatment Period 4 (3 Days) COMPLETED	3	3	2	3
Treatment Period 4 (3 Days) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Sequence 1: A Then B Then C Then D Participants were randomized to receive a single oral dose of treatment A on Day 1 of Period 1; followed by a single oral dose of treatment B on Day 1 of Period 2; followed by a single oral dose of treatment C on Day 1 of Period 3; followed by a single oral dose of treatment D on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 milligram (mg) tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.	Treatment Sequence 2: B Then D Then A Then C Participants were randomized to receive a single oral dose of treatment B on Day 1 of Period 1; followed by a single oral dose of treatment D on Day 1 of Period 2; followed by a single oral dose of treatment A on Day 1 of Period 3; followed by a single oral dose of treatment C on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.	Treatment Sequence 3: C Then A Then D Then B Participants were randomized to receive a single oral dose of treatment C on Day 1 of Period 1; followed by a single oral dose of treatment A on Day 1 of Period 2; followed by a single oral dose of treatment D on Day 1 of Period 3; followed by a single oral dose of treatment B on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.	Treatment Sequence 4: D Then C Then B Then A Participants were randomized to receive a single oral dose of treatment D on Day 1 of Period 1; followed by a single oral dose of treatment C on Day 1 of Period 2; followed by a single oral dose of treatment B on Day 1 of Period 3; followed by a single oral dose of treatment A on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.
Treatment Period 1 (3 Days) Adverse Event	0	0	1	0

Baseline Characteristics

A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Sequence 1: A Then B Then C Then D n=3 Participants Participants were randomized to receive a single oral dose of treatment A on Day 1 of Period 1; followed by a single oral dose of treatment B on Day 1 of Period 2; followed by a single oral dose of treatment C on Day 1 of Period 3; followed by a single oral dose of treatment D on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.	Treatment Sequence 2: B Then D Then A Then C n=3 Participants Participants were randomized to receive a single oral dose of treatment B on Day 1 of Period 1; followed by a single oral dose of treatment D on Day 1 of Period 2; followed by a single oral dose of treatment A on Day 1 of Period 3; followed by a single oral dose of treatment C on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.	Treatment Sequence 3: C Then A Then D Then B n=3 Participants Participants were randomized to receive a single oral dose of treatment C on Day 1 of Period 1; followed by a single oral dose of treatment A on Day 1 of Period 2; followed by a single oral dose of treatment D on Day 1 of Period 3; followed by a single oral dose of treatment B on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.	Treatment Sequence 4: D Then C Then B Then A n=3 Participants Participants were randomized to receive a single oral dose of treatment D on Day 1 of Period 1; followed by a single oral dose of treatment C on Day 1 of Period 2; followed by a single oral dose of treatment B on Day 1 of Period 3; followed by a single oral dose of treatment A on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.	Total n=12 Participants Total of all reporting groups
Age, Continuous Mean (SD)	58.7 Years STANDARD_DEVIATION 4.93 • n=5 Participants	34.7 Years STANDARD_DEVIATION 3.06 • n=7 Participants	41.3 Years STANDARD_DEVIATION 18.15 • n=5 Participants	51.0 Years STANDARD_DEVIATION 21.28 • n=4 Participants	46.4 Years STANDARD_DEVIATION 15.48 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	11 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	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) 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	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) 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	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	12 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	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period

Population: Pharmacokinetic (PK) parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest in at least 1 treatment period.

Outcome measures

Outcome measures
Measure	Treatment A: PF-07817883 300 mg Reference Formulation n=11 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of reference formulation on Day 1 of any period.	Treatment B: PF-07817883 300 mg Test Formulation 1 n=11 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 1 on Day 1 of any period.	Treatment C: PF-07817883 300 mg Test Formulation 2 n=12 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period.	Treatment D: PF-07817883 300 mg Test Formulation 3 n=11 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period.
Maximum Observed Plasma Concentration (Cmax) of PF-07817883	2308 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 39	2579 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 28	4266 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 40	3566 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 34

PRIMARY outcome

Timeframe: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period

Population: PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest in at least 1 treatment period. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Treatment A: PF-07817883 300 mg Reference Formulation n=10 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of reference formulation on Day 1 of any period.	Treatment B: PF-07817883 300 mg Test Formulation 1 n=9 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 1 on Day 1 of any period.	Treatment C: PF-07817883 300 mg Test Formulation 2 n=10 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period.	Treatment D: PF-07817883 300 mg Test Formulation 3 n=10 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period.
Area Under the Concentration-time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07817883	17660 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 35	18200 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 22	21040 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 36	21510 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 33

SECONDARY outcome

Timeframe: From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days)

Population: Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment in at least one treatment period. Participants were analyzed according to the product they actually received.

An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Treatment-emergent are events between first dose of study treatment and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Outcome measures

Outcome measures
Measure	Treatment A: PF-07817883 300 mg Reference Formulation n=11 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of reference formulation on Day 1 of any period.	Treatment B: PF-07817883 300 mg Test Formulation 1 n=11 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 1 on Day 1 of any period.	Treatment C: PF-07817883 300 mg Test Formulation 2 n=12 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period.	Treatment D: PF-07817883 300 mg Test Formulation 3 n=11 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	2 Participants	2 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)

Laboratory parameters included hematology (eosinophils/leukocytes \[%\] greater than \[\>\] 1.2\*upper limit of normal), and urinalysis (urine hemoglobin and leukocyte esterase greater than or equal \[\>=\] to 1).

Outcome measures

Outcome measures
Measure	Treatment A: PF-07817883 300 mg Reference Formulation n=3 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of reference formulation on Day 1 of any period.	Treatment B: PF-07817883 300 mg Test Formulation 1 n=1 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 1 on Day 1 of any period.	Treatment C: PF-07817883 300 mg Test Formulation 2 n=1 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period.	Treatment D: PF-07817883 300 mg Test Formulation 3 n=3 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period.
Number of Participants With Laboratory Test Abnormalities	1 Participants	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)

Vital signs included diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate (PR) were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value less than (\<) 90 millimeters of mercury (mmHg), change from baseline greater than or equal to (\>=) 30 mmHg increase, change from baseline \>=30 mmHg decrease; DBP: value \<50 mmHg, change from baseline \>=20 mmHg increase, change from baseline \>=20 mmHg decrease; PR: value \<40 beats per minute (bpm), value greater than (\>) 120 bpm.

Outcome measures

Outcome measures
Measure	Treatment A: PF-07817883 300 mg Reference Formulation n=11 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of reference formulation on Day 1 of any period.	Treatment B: PF-07817883 300 mg Test Formulation 1 n=11 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 1 on Day 1 of any period.	Treatment C: PF-07817883 300 mg Test Formulation 2 n=12 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period.	Treatment D: PF-07817883 300 mg Test Formulation 3 n=11 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period.
Number of Participants With Clinically Significant Abnormality in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)

Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest. Criteria were PR interval (\>=300 millisecond \[msec\], percent \[%\] change from baseline \>=25 to 50%), QRS duration (\>=140 msec, %change from baseline \>=50%), corrected QT interval using Fridericia's formula (QTcF) (\>500 msec, %change from baseline \>60 msec, 450 msec\<value less than equal to \[\<=\] 480 msec, 480 msec\<value\<=500 msec, 30 msec\<=change\<=60 msec).

Outcome measures

Outcome measures
Measure	Treatment A: PF-07817883 300 mg Reference Formulation n=11 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of reference formulation on Day 1 of any period.	Treatment B: PF-07817883 300 mg Test Formulation 1 n=11 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 1 on Day 1 of any period.	Treatment C: PF-07817883 300 mg Test Formulation 2 n=12 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period.	Treatment D: PF-07817883 300 mg Test Formulation 3 n=11 Participants Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period.
Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Treatment A: PF-07817883 300 mg Reference Formulation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Treatment B: PF-07817883 300 mg Test Formulation 1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Treatment C: PF-07817883 300 mg Test Formulation 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Treatment D: PF-07817883 300 mg Test Formulation 3

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment A: PF-07817883 300 mg Reference Formulation n=11 participants at risk Participants received PF-07817883 300 mg, tablet, orally as single dose of reference formulation on Day 1 of any period.	Treatment B: PF-07817883 300 mg Test Formulation 1 n=11 participants at risk Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 1 on Day 1 of any period.	Treatment C: PF-07817883 300 mg Test Formulation 2 n=12 participants at risk Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period.	Treatment D: PF-07817883 300 mg Test Formulation 3 n=11 participants at risk Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	8.3% 1/12 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.
Gastrointestinal disorders Lip dry	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	9.1% 1/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/12 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.
Gastrointestinal disorders Nausea	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	8.3% 1/12 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.
General disorders Vessel puncture site bruise	9.1% 1/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/12 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.
Infections and infestations Influenza	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	8.3% 1/12 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	9.1% 1/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/12 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.
Nervous system disorders Headache	9.1% 1/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	8.3% 1/12 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	9.1% 1/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.
Renal and urinary disorders Polyuria	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	8.3% 1/12 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.
Vascular disorders Haematoma	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/12 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	9.1% 1/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.
Vascular disorders Hypertension	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	8.3% 1/12 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.	0.00% 0/11 • From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.

Additional Information

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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 publication 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