Trial Outcomes & Findings for A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants (NCT NCT05431153)
NCT ID: NCT05431153
Last Updated: 2024-04-08
Results Overview
AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Results posted on
2024-04-08
Participant Flow
A total of 30 participants were randomly assigned and received the study treatment.
Participant milestones
| Measure |
Treatment Sequence ABCD
Participants received a single 300 milligrams (mg) dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation A under fasting conditions (Treatment A) on Day 1 of period 1 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 2 followed by 300 mg (4\*75 mg) tablet Formulation C under fasting condition (Treatment C) on Day 1 of period 3 followed by 300 mg (4\*75 mg) tablet Formulation D under fasting condition (Treatment D) on Day 1 of period 4. There was a washout period of 5 days between each treatment period.
|
Treatment Sequence BCAD
Participants received a single 300 mg (2\*125 mg and 2\*25 mg) PF-07104091 tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 1 followed by 300 mg (4\*75 mg) tablet Formulation C under fasted condition (Treatment C) on Day 1 of treatment period 2 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation A under fasting condition (Treatment A) on Day 1 of period 3 followed by 300 mg (4\*75 mg) tablet Formulation D under fasted condition (Treatment D) on Day 1 of period 4. There was a washout period of 5 days between each treatment period.
|
Treatment Sequence CABD
Participants received a single 300 mg (4\*75 mg) PF-07104091 tablet Formulation C under fasting condition (Treatment C) on Day 1 of period 1 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation A under fasting condition (Treatment A) on Day 1 of period 2 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 3 followed by 300 mg (4\*75 mg) tablet Formulation D under fasting condition (Treatment D) on Day 1 of period 4. There was a washout period of 5 days between each treatment period.
|
Treatment Sequence ABCE
Participants received a single 300 mg (2\*125 mg and 2\*25 mg) PF-07104091 tablet Formulation A under fasting condition (Treatment A) on Day 1 of period 1 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 2 followed by 300 mg (4\*75 mg) tablet Formulation C under fasting condition (Treatment C) on Day 1 of period 3 followed by 300 mg (4\*75 mg) tablet Formulation C under fed condition (Treatment E) on Day 1 of period 4. There was a washout period of 5 days between each treatment period.
|
Treatment Sequence BCAE
Participants received a single 300 mg (2\*125 mg and 2\*25 mg) PF-07104091 tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 1 followed by 300 mg (4\*75 mg) tablet Formulation C under fasting condition (Treatment C) on Day 1 of period 2 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation A under fasting condition (Treatment A) on Day 1 of period 3 followed by 300 mg (4\*75 mg) tablet Formulation C under fed condition (Treatment E) on Day 1 of period 4. There was a washout period of 5 days between each treatment period.
|
Treatment Sequence CABE
Participants received a single 300 mg (4\*75 mg) PF-07104091 tablet Formulation C under fasting condition (Treatment C) on Day 1 of period 1 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation A under fasting condition (Treatment A) on Day 1 of period 2 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 3 followed by 300 mg (4\*75 mg) tablet Formulation C under fed condition (Treatment E) on Day 1 of period 4. There was a washout period of 5 days between each treatment period.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1 (Day 1)
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Treatment Period 1 (Day 1)
COMPLETED
|
5
|
5
|
5
|
5
|
4
|
5
|
|
Treatment Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Washout Period 1 (5 Days)
STARTED
|
5
|
5
|
5
|
5
|
4
|
5
|
|
Washout Period 1 (5 Days)
COMPLETED
|
5
|
5
|
5
|
5
|
4
|
5
|
|
Washout Period 1 (5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (Day 1)
STARTED
|
5
|
5
|
5
|
5
|
4
|
5
|
|
Treatment Period 2 (Day 1)
COMPLETED
|
5
|
5
|
5
|
5
|
4
|
5
|
|
Treatment Period 2 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (5 Days)
STARTED
|
5
|
5
|
5
|
5
|
4
|
5
|
|
Washout Period 2 (5 Days)
COMPLETED
|
5
|
5
|
5
|
5
|
4
|
5
|
|
Washout Period 2 (5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3 (Day 1)
STARTED
|
5
|
5
|
5
|
5
|
4
|
5
|
|
Treatment Period 3 (Day 1)
COMPLETED
|
5
|
5
|
5
|
5
|
4
|
5
|
|
Treatment Period 3 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 3 (5 Days)
STARTED
|
5
|
5
|
5
|
5
|
4
|
5
|
|
Washout Period 3 (5 Days)
COMPLETED
|
5
|
5
|
5
|
5
|
4
|
5
|
|
Washout Period 3 (5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 4 (Day 1)
STARTED
|
5
|
5
|
5
|
5
|
4
|
5
|
|
Treatment Period 4 (Day 1)
COMPLETED
|
5
|
5
|
5
|
5
|
4
|
5
|
|
Treatment Period 4 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence ABCD
Participants received a single 300 milligrams (mg) dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation A under fasting conditions (Treatment A) on Day 1 of period 1 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 2 followed by 300 mg (4\*75 mg) tablet Formulation C under fasting condition (Treatment C) on Day 1 of period 3 followed by 300 mg (4\*75 mg) tablet Formulation D under fasting condition (Treatment D) on Day 1 of period 4. There was a washout period of 5 days between each treatment period.
|
Treatment Sequence BCAD
Participants received a single 300 mg (2\*125 mg and 2\*25 mg) PF-07104091 tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 1 followed by 300 mg (4\*75 mg) tablet Formulation C under fasted condition (Treatment C) on Day 1 of treatment period 2 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation A under fasting condition (Treatment A) on Day 1 of period 3 followed by 300 mg (4\*75 mg) tablet Formulation D under fasted condition (Treatment D) on Day 1 of period 4. There was a washout period of 5 days between each treatment period.
|
Treatment Sequence CABD
Participants received a single 300 mg (4\*75 mg) PF-07104091 tablet Formulation C under fasting condition (Treatment C) on Day 1 of period 1 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation A under fasting condition (Treatment A) on Day 1 of period 2 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 3 followed by 300 mg (4\*75 mg) tablet Formulation D under fasting condition (Treatment D) on Day 1 of period 4. There was a washout period of 5 days between each treatment period.
|
Treatment Sequence ABCE
Participants received a single 300 mg (2\*125 mg and 2\*25 mg) PF-07104091 tablet Formulation A under fasting condition (Treatment A) on Day 1 of period 1 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 2 followed by 300 mg (4\*75 mg) tablet Formulation C under fasting condition (Treatment C) on Day 1 of period 3 followed by 300 mg (4\*75 mg) tablet Formulation C under fed condition (Treatment E) on Day 1 of period 4. There was a washout period of 5 days between each treatment period.
|
Treatment Sequence BCAE
Participants received a single 300 mg (2\*125 mg and 2\*25 mg) PF-07104091 tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 1 followed by 300 mg (4\*75 mg) tablet Formulation C under fasting condition (Treatment C) on Day 1 of period 2 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation A under fasting condition (Treatment A) on Day 1 of period 3 followed by 300 mg (4\*75 mg) tablet Formulation C under fed condition (Treatment E) on Day 1 of period 4. There was a washout period of 5 days between each treatment period.
|
Treatment Sequence CABE
Participants received a single 300 mg (4\*75 mg) PF-07104091 tablet Formulation C under fasting condition (Treatment C) on Day 1 of period 1 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation A under fasting condition (Treatment A) on Day 1 of period 2 followed by 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 3 followed by 300 mg (4\*75 mg) tablet Formulation C under fed condition (Treatment E) on Day 1 of period 4. There was a washout period of 5 days between each treatment period.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1 (Day 1)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Investigate the Effect of Tablet Formulation and Food on PF-07104091 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Treatment Sequence ABCD+BCAD+CABD
n=15 Participants
All participants who received Treatment A: PF-07104091 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation A, under fasting condition, treatment B: 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation B under fasting condition, treatment C: 300 mg (4\*75 mg) tablet Formulation C under fasting condition, treatment D: 300 mg (4\*75 mg) tablet Formulation D under fasting condition, in either Period 1, 2, 3, and 4 based on the treatment sequence were included.
|
Treatment Sequence ABCE+BCAE+CABE
n=15 Participants
All participants who received Treatment A: PF-07104091 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation A, under fasting condition, treatment B: 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation B, under fasting condition, treatment C: 300 mg (4\*75 mg) tablet Formulation C under fasting condition, treatment E: 300 mg (4\*75 mg) tablet Formulation C under fed condition in either Period 1, 2, 3, and 4 based on the treatment sequence were included.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.9 Years
STANDARD_DEVIATION 13.04 • n=5 Participants
|
40.3 Years
STANDARD_DEVIATION 13.06 • n=7 Participants
|
41.1 Years
STANDARD_DEVIATION 12.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dosePopulation: Pharmacokinetic (PK) Parameter set included all participants randomized and treated who had at least 1 of the PF-07104091 PK parameters of primary interest in at least 1 treatment period. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve.
Outcome measures
| Measure |
Treatment A: PF-07104091 Tablet Formulation A (Fasted)
n=21 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation A, under fasting conditions.
|
Treatment B: PF-07104091 Tablet Formulation B (Fasted)
n=18 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation B, under fasting conditions.
|
Treatment C: PF-07104091 Tablet Formulation C (Fasted)
n=19 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, under fasting conditions.
|
Treatment D: PF-07104091 Tablet Formulation D (Fasted)
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions.
|
Treatment E: PF-07104091 Tablet Formulation C (Fed)
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal.
|
|---|---|---|---|---|---|
|
Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C
|
10920 Nanograms*hour per milliliter
Geometric Coefficient of Variation 34
|
10720 Nanograms*hour per milliliter
Geometric Coefficient of Variation 28
|
11200 Nanograms*hour per milliliter
Geometric Coefficient of Variation 32
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dosePopulation: PK Parameter set included all participants randomized and treated who had at least 1 of the PF-07104091 PK parameters of primary interest in at least 1 treatment period. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Cmax was maximum observed concentration. Cmax was observed directly from data.
Outcome measures
| Measure |
Treatment A: PF-07104091 Tablet Formulation A (Fasted)
n=27 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation A, under fasting conditions.
|
Treatment B: PF-07104091 Tablet Formulation B (Fasted)
n=28 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation B, under fasting conditions.
|
Treatment C: PF-07104091 Tablet Formulation C (Fasted)
n=27 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, under fasting conditions.
|
Treatment D: PF-07104091 Tablet Formulation D (Fasted)
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions.
|
Treatment E: PF-07104091 Tablet Formulation C (Fed)
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-07104091 for Treatment A, B and C
|
1531 Nanograms per milliliter
Geometric Coefficient of Variation 31
|
1490 Nanograms per milliliter
Geometric Coefficient of Variation 28
|
1415 Nanograms per milliliter
Geometric Coefficient of Variation 34
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dosePopulation: PK Parameter set included all participants randomized and treated who had at least 1 of the PF-07104091 PK parameters of primary interest in at least 1 treatment period. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve.
Outcome measures
| Measure |
Treatment A: PF-07104091 Tablet Formulation A (Fasted)
n=19 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation A, under fasting conditions.
|
Treatment B: PF-07104091 Tablet Formulation B (Fasted)
n=10 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation B, under fasting conditions.
|
Treatment C: PF-07104091 Tablet Formulation C (Fasted)
n=11 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, under fasting conditions.
|
Treatment D: PF-07104091 Tablet Formulation D (Fasted)
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions.
|
Treatment E: PF-07104091 Tablet Formulation C (Fed)
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal.
|
|---|---|---|---|---|---|
|
AUCinf of PF-07104091 for Treatment C, D and E
|
11200 Nanograms*hour per milliliter
Geometric Coefficient of Variation 32
|
12850 Nanograms*hour per milliliter
Geometric Coefficient of Variation 32
|
10500 Nanograms*hour per milliliter
Geometric Coefficient of Variation 24
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dosePopulation: PK Parameter set included all participants randomized and treated who had at least 1 of the PF-07104091 PK parameters of primary interest in at least 1 treatment period. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Cmax was maximum observed concentration. Cmax was observed directly from data.
Outcome measures
| Measure |
Treatment A: PF-07104091 Tablet Formulation A (Fasted)
n=27 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation A, under fasting conditions.
|
Treatment B: PF-07104091 Tablet Formulation B (Fasted)
n=13 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation B, under fasting conditions.
|
Treatment C: PF-07104091 Tablet Formulation C (Fasted)
n=14 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, under fasting conditions.
|
Treatment D: PF-07104091 Tablet Formulation D (Fasted)
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions.
|
Treatment E: PF-07104091 Tablet Formulation C (Fed)
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal.
|
|---|---|---|---|---|---|
|
Cmax of PF-07104091 for Treatment C, D and E
|
1415 Nanograms per milliliter
Geometric Coefficient of Variation 34
|
1498 Nanograms per milliliter
Geometric Coefficient of Variation 36
|
1193 Nanograms per milliliter
Geometric Coefficient of Variation 36
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention 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 adverse event (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, other important medical events. TEAEs were defined as events that occurred after start of treatment.
Outcome measures
| Measure |
Treatment A: PF-07104091 Tablet Formulation A (Fasted)
n=29 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation A, under fasting conditions.
|
Treatment B: PF-07104091 Tablet Formulation B (Fasted)
n=30 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation B, under fasting conditions.
|
Treatment C: PF-07104091 Tablet Formulation C (Fasted)
n=29 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, under fasting conditions.
|
Treatment D: PF-07104091 Tablet Formulation D (Fasted)
n=15 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions.
|
Treatment E: PF-07104091 Tablet Formulation C (Fed)
n=14 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs
|
21 Participants
|
19 Participants
|
17 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Clinical hematology parameters included: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes; chemistry parameters included: blood urea nitrogen and creatinine, cystatin C and estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, urinalysis parameters included: local dipstick: potential of hydrogen (pH), glucose, protein, blood, ketones, nitrites, leukocyte esterase. Number of participants with abnormal findings are presented in this outcome measure.
Outcome measures
| Measure |
Treatment A: PF-07104091 Tablet Formulation A (Fasted)
n=29 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation A, under fasting conditions.
|
Treatment B: PF-07104091 Tablet Formulation B (Fasted)
n=30 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation B, under fasting conditions.
|
Treatment C: PF-07104091 Tablet Formulation C (Fasted)
n=29 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, under fasting conditions.
|
Treatment D: PF-07104091 Tablet Formulation D (Fasted)
n=15 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions.
|
Treatment E: PF-07104091 Tablet Formulation C (Fed)
n=14 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal.
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
A 12-lead ECG was performed. Clinically meaningful findings in ECG assessments were based on the investigator's judgment.
Outcome measures
| Measure |
Treatment A: PF-07104091 Tablet Formulation A (Fasted)
n=29 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation A, under fasting conditions.
|
Treatment B: PF-07104091 Tablet Formulation B (Fasted)
n=30 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation B, under fasting conditions.
|
Treatment C: PF-07104091 Tablet Formulation C (Fasted)
n=29 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, under fasting conditions.
|
Treatment D: PF-07104091 Tablet Formulation D (Fasted)
n=15 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions.
|
Treatment E: PF-07104091 Tablet Formulation C (Fed)
n=14 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Vital signs were measured with the participant's arm supported at the level of the heart after approximately 5 minutes of rest. Vital signs parameters included: diastolic and systolic blood pressure, respiratory rate, pulse rate, and temperature. Number of participants with clinically meaningful findings in any vital sign parameter were reported. Clinically meaningful findings were based on the investigator's judgment.
Outcome measures
| Measure |
Treatment A: PF-07104091 Tablet Formulation A (Fasted)
n=29 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation A, under fasting conditions.
|
Treatment B: PF-07104091 Tablet Formulation B (Fasted)
n=30 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation B, under fasting conditions.
|
Treatment C: PF-07104091 Tablet Formulation C (Fasted)
n=29 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, under fasting conditions.
|
Treatment D: PF-07104091 Tablet Formulation D (Fasted)
n=15 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions.
|
Treatment E: PF-07104091 Tablet Formulation C (Fed)
n=14 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Meaningful Findings in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
A complete physical examination included at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant-reported symptoms. Clinically significant findings were defined according to investigator's assessment.
Outcome measures
| Measure |
Treatment A: PF-07104091 Tablet Formulation A (Fasted)
n=29 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation A, under fasting conditions.
|
Treatment B: PF-07104091 Tablet Formulation B (Fasted)
n=30 Participants
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation B, under fasting conditions.
|
Treatment C: PF-07104091 Tablet Formulation C (Fasted)
n=29 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, under fasting conditions.
|
Treatment D: PF-07104091 Tablet Formulation D (Fasted)
n=15 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions.
|
Treatment E: PF-07104091 Tablet Formulation C (Fed)
n=14 Participants
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Meaningful Findings in Physical Examination Assessments
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment A: PF-07104091 Tablet Formulation A (Fasted)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Treatment B: PF-07104091 Tablet Formulation B (Fasted)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Treatment C: PF-07104091 Tablet Formulation C (Fasted)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Treatment D: PF-07104091 Tablet Formulation D (Fasted)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment E: PF-07104091 Tablet Formulation C (Fed)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: PF-07104091 Tablet Formulation A (Fasted)
n=29 participants at risk
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation A, under fasting conditions.
|
Treatment B: PF-07104091 Tablet Formulation B (Fasted)
n=30 participants at risk
Participants received a single 300 mg dose (2\*125 mg and 2\*25 mg) of PF-07104091 tablet Formulation B, under fasting conditions.
|
Treatment C: PF-07104091 Tablet Formulation C (Fasted)
n=29 participants at risk
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, under fasting conditions.
|
Treatment D: PF-07104091 Tablet Formulation D (Fasted)
n=15 participants at risk
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions.
|
Treatment E: PF-07104091 Tablet Formulation C (Fed)
n=14 participants at risk
Participants received a single 300 mg dose (4\*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/30 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
6.7%
1/15 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/14 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.2%
5/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
13.3%
4/30 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
17.2%
5/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
6.7%
1/15 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/14 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
3.3%
1/30 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
13.3%
2/15 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/14 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Eructation
|
6.9%
2/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/30 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/20 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/15 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/14 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Nausea
|
90.0%
18/20 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
46.7%
14/30 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
44.8%
13/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
26.7%
4/15 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
7.1%
1/14 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
20.7%
6/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
23.3%
7/30 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
10.3%
3/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
20.0%
3/15 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/14 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
|
General disorders
Chills
|
6.9%
2/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/30 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/15 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/14 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
|
General disorders
Fatigue
|
3.4%
1/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
3.3%
1/30 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
10.3%
3/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
6.7%
1/15 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/14 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
|
General disorders
Pain
|
0.00%
0/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/30 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/15 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
7.1%
1/14 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/30 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
6.7%
1/15 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/14 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/20 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/30 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/15 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
7.1%
1/14 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Dizziness
|
10.3%
3/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
3.3%
1/30 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
10.3%
3/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
6.7%
1/15 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
7.1%
1/14 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/30 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
6.7%
1/15 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/14 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/30 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
3.4%
1/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/15 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
7.1%
1/14 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Headache
|
10.3%
3/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
16.7%
5/30 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
10.3%
3/29 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
13.3%
2/15 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
0.00%
0/14 • From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER