Trial Outcomes & Findings for A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants. (NCT NCT05767905)

Last Updated: 2025-06-12

Results Overview

The AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. AUClast is the area under the concentration-time curve from 0 to time of last measurable concentration

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.

Results posted on

2025-06-12

Participant Flow

A total of 18 participants (12 participants in Part 1 and 6 participants in Part 2) were randomized and assigned to study treatments.

Participant milestones

Participant milestones
Measure	Part 1: PF-06821497 Form 1 250 mg -> PF-06821497 Form 2 250 mg -> PF-06821497 Form 3 250 mg. Participants received PF-06821497 (formulation 1) 250 mg material sparing tablet (MST) on Day 1 of period 1 under fasted condition, and after a minimum of 5-day washout period, participants received PF-06821497 (formulation 2) 250 mg wet granulation (WG) tablet on Day 1 of period 2 under fasted condition. Then after a minimum of 5-day washout period, participants received PF-06821497 (formulation 3) 250 mg WG tablet (larger API particle size) on Day 1 of period 3 under fasted condition.	Part 1: PF-06821497 Form 2 250 mg -> PF-06821497 Form 1 250 mg -> PF-06821497 Form 3 250 mg Participants received PF-06821497 (formulation 2) 250 mg WG tablet on Day 1 of period 1 under fasted condition, and after a minimum of 5-day washout period, participants received PF-06821497 (formulation 1) 250 mg MST tablet on Day 1 of period 2 under fasted condition. Then after a minimum of 5-day washout period, participants received PF-06821497 (formulation 3) 250 mg WG tablet (larger API particle size) on Day 1 of period 3 under fasted condition.	Part 2:PF-06821497 1250 mg Fasted >PF-06821497 1250 mg Fed Low-fat >PF-06821497 1250 mg Fed High-fat Participants received PF-06821497 (formulation 2) 1250 mg WG tablet on Day 1 of period 1 under fasted condition, and after a minimum of 5-day washout period, participants received a received a low-fat, low-calorie breakfast 30 minutes prior to dosing of PF-06821497 (formulation 2) 1250 mg WG tablet on Day 1 of period 2. Then after a minimum of 5-day washout period, participants received a a high-fat, high-calorie breakfast 30 minutes prior to dosing of PF-06821497 (formulation 2) 1250mg WG tablet.
Overall Study STARTED	6	6	6
Overall Study COMPLETED	6	6	5
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: PF-06821497 Form 1 250 mg -> PF-06821497 Form 2 250 mg -> PF-06821497 Form 3 250 mg. Participants received PF-06821497 (formulation 1) 250 mg material sparing tablet (MST) on Day 1 of period 1 under fasted condition, and after a minimum of 5-day washout period, participants received PF-06821497 (formulation 2) 250 mg wet granulation (WG) tablet on Day 1 of period 2 under fasted condition. Then after a minimum of 5-day washout period, participants received PF-06821497 (formulation 3) 250 mg WG tablet (larger API particle size) on Day 1 of period 3 under fasted condition.	Part 1: PF-06821497 Form 2 250 mg -> PF-06821497 Form 1 250 mg -> PF-06821497 Form 3 250 mg Participants received PF-06821497 (formulation 2) 250 mg WG tablet on Day 1 of period 1 under fasted condition, and after a minimum of 5-day washout period, participants received PF-06821497 (formulation 1) 250 mg MST tablet on Day 1 of period 2 under fasted condition. Then after a minimum of 5-day washout period, participants received PF-06821497 (formulation 3) 250 mg WG tablet (larger API particle size) on Day 1 of period 3 under fasted condition.	Part 2:PF-06821497 1250 mg Fasted >PF-06821497 1250 mg Fed Low-fat >PF-06821497 1250 mg Fed High-fat Participants received PF-06821497 (formulation 2) 1250 mg WG tablet on Day 1 of period 1 under fasted condition, and after a minimum of 5-day washout period, participants received a received a low-fat, low-calorie breakfast 30 minutes prior to dosing of PF-06821497 (formulation 2) 1250 mg WG tablet on Day 1 of period 2. Then after a minimum of 5-day washout period, participants received a a high-fat, high-calorie breakfast 30 minutes prior to dosing of PF-06821497 (formulation 2) 1250mg WG tablet.
Overall Study Adverse Event	0	0	1

Baseline Characteristics

A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1 n=12 Participants In Part 1, each enrolled participant participated in 3 study periods to receive 3 different treatments(Treatment A: Single 250 mg dose (1 × 250 mg) of MST tablet formulation (Formulation 1), fasted; Treatment B: Single 250 mg dose (1 × 250 mg) of WG tablet formulation (Formulation 2), fasted; Treatment C: Single 250 mg dose (1 × 250 mg) of WG tablet formulation (larger API particle size) (Formulation 3), fasted.) according to the sequence determined by randomization with 5-day washouts between PF-06821497 administration.	Part 2 n=6 Participants In Part 2, each enrolled participant participated in 3 study periods to receive 3 different treatments (Treatment D: Single 1250 mg dose (5 × 250 mg) of WG tablet formulation (Formulation 2), fasted; Treatment E: Single 1250 mg dose (5 × 250 mg) of WG tablet formulation (Formulation 2), fed, low-fat; Treatment F: Single 1250 mg dose (5 × 250 mg) of WG tablet formulation (Formulation 2), fed, high-fat.) according to the sequence determined by randomization with 5-day washouts between PF-06821497 administration.	Total n=18 Participants Total of all reporting groups
Age, Customized 18 -44 years	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Age, Customized 45 - 64 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Customized >= 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized White	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American, White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American, White, American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.

Population: The pharmacokinetic (PK) parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PF-06821497 PK parameters of primary interest in at least 1 treatment period.

Outcome measures

Outcome measures
Measure	Part 1 PF-06821497 Form 1 250 mg Fasted n=12 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 material sparing tablet (MST).	Part 1 PF-06821497 Form 2 250 mg Fasted n=12 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 wet granulation (WG) tablet.	Part 1 PF-06821497 Form 3 250 mg Fasted n=12 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size).	Part 2 PF-06821497 Form 2 1250 mg Fasted n=6 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1, participants received a 1250 mg dose of PF-06821497 WG tablet.	Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat n=6 Participants Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet	Part 2 PF-06821497 Form 2 1250 mg Fed High-fat n=5 Participants Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06821497	3302 ng*hr/mL Geometric Coefficient of Variation 33	3375 ng*hr/mL Geometric Coefficient of Variation 29	3479 ng*hr/mL Geometric Coefficient of Variation 39	11220 ng*hr/mL Geometric Coefficient of Variation 48	22810 ng*hr/mL Geometric Coefficient of Variation 24	25690 ng*hr/mL Geometric Coefficient of Variation 35

PRIMARY outcome

Timeframe: Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.

Population: The PK concentration population was defined as all participants randomized and treated who had at least 1 PF-06821497 concentration in at least 1 treatment period.

The Cmax was observed directly from data.

Outcome measures

Outcome measures
Measure	Part 1 PF-06821497 Form 1 250 mg Fasted n=12 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 material sparing tablet (MST).	Part 1 PF-06821497 Form 2 250 mg Fasted n=12 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 wet granulation (WG) tablet.	Part 1 PF-06821497 Form 3 250 mg Fasted n=12 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size).	Part 2 PF-06821497 Form 2 1250 mg Fasted n=6 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1, participants received a 1250 mg dose of PF-06821497 WG tablet.	Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat n=6 Participants Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet	Part 2 PF-06821497 Form 2 1250 mg Fed High-fat n=5 Participants Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet
Maximum Plasma Concentration (Cmax) for PF-06821497.	862.6 ng/mL Geometric Coefficient of Variation 50	1023 ng/mL Geometric Coefficient of Variation 35	1255 ng/mL Geometric Coefficient of Variation 37	2699 ng/mL Geometric Coefficient of Variation 31	7685 ng/mL Geometric Coefficient of Variation 28	8905 ng/mL Geometric Coefficient of Variation 7

SECONDARY outcome

Timeframe: From screening up to Day 35

Population: The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants was analyzed according to the product they actually received.

An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, was considered serious.

Outcome measures

Outcome measures
Measure	Part 1 PF-06821497 Form 1 250 mg Fasted n=12 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 material sparing tablet (MST).	Part 1 PF-06821497 Form 2 250 mg Fasted n=12 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 wet granulation (WG) tablet.	Part 1 PF-06821497 Form 3 250 mg Fasted n=12 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size).	Part 2 PF-06821497 Form 2 1250 mg Fasted n=6 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1, participants received a 1250 mg dose of PF-06821497 WG tablet.	Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat n=6 Participants Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet	Part 2 PF-06821497 Form 2 1250 mg Fed High-fat n=5 Participants Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet
Number of Participants With Treatment Emergent Adverse Events (TEAEs).	5 Participants	4 Participants	2 Participants	3 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.

Population: The analysis population included all participants randomly assigned to study intervention and who took at least one dose of study intervention.

Safety laboratory assessments included urinalysis, hematology, chemistry and other. All the safety laboratory samples were collected following at least a 4-hour fast.

Outcome measures

Outcome measures
Measure	Part 1 PF-06821497 Form 1 250 mg Fasted n=12 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 material sparing tablet (MST).	Part 1 PF-06821497 Form 2 250 mg Fasted n=12 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 wet granulation (WG) tablet.	Part 1 PF-06821497 Form 3 250 mg Fasted n=12 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size).	Part 2 PF-06821497 Form 2 1250 mg Fasted n=6 Participants Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1, participants received a 1250 mg dose of PF-06821497 WG tablet.	Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat n=6 Participants Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet	Part 2 PF-06821497 Form 2 1250 mg Fed High-fat n=5 Participants Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet
Number of Participants With Laboratory Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.

Population: The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Single 12-lead electrocardiogram or electrocardiography (ECG) readings were taken at approximately each test. All ECG assessments were made after at least a 5-minute rest in a supine position and prior to any blood draws or vital sign measurements.