This study has two parts: Part A and Part B. The purpose of Part A of this study is to learn about the safety, tolerability, and how PF-07328948 is processed by the body when multiple doses of PF-07328948 are given to healthy participants. The purpose of Part B of this study is to understand the amount of PF-07328948 that would be available in the body after taking a single pill. The amount will be compared to the amount of PF-07328948 in a suspension in healthy adults. Part B will be conducted if the results of Part A support further study of PF-07328948. The study is seeking participants who: * are females who are not able to give birth to a child of 18 years of age or older. * are males of 18 years of age or older. * have a BMI of 20.0 to 35.0 kg/m2. * have total body weight of more than 50 kg (110 lbs). Participants in Part A will be randomly selected to receive either PF-07328948 or placebo (a pill that has no medicine in it). Participants in Part B will receive PF-07328948 as suspension and tablet form, both taken by mouth after food or during fasting. For a given participant in Part A, the total study is going to last up to about 12 weeks. This includes from the time of selection till the last follow-up phone call. The participants will be selected if they are fit for the study 28 days before the first dose of the study medicines. Participants who are selected will be admitted to the study site on Day -2 for around 19 days. Following discharge, participants will return for an on-site follow-up visit 7 to 10 days after receiving the final dose of the study medicine. The follow-up contact may be via a telephone call and will happen 28 to 35 days after the final dose of study medicine is given. For a given participant in Part B, the total study is going to last up to about 10-12 weeks. Participants will stay overnight at the CRU for 23 days (Sequence 1) or 18 days (Sequence 2), starting with check-in. In Sequence 1, there will be a minimum of 10 days between doses in Period 1 and 2, and at least 7 days between doses in Period 2 and Period 3. In Sequence 2, there will be a minimum of 7 days between each dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
86
PF-07328948 will be administered as oral suspensions every 12 hour (BID) over 14 days
Placebo will be administered as oral suspensions BID over 14 days
PF-07328948 will be administered as oral suspensions daily (QD) over 14 days
Placebo will be administered as oral suspensions QD over 14 days
PF-07328948 will be administered as oral suspensions every QD over 14 days
Placebo will be administered as oral suspensions QD over 14 days
PF-07328948 will be administered as oral suspensions QD over 14 days
Placebo will be administered as oral suspensions QD over 14 days
PF-07328948 will be administered as oral suspensions QD over 14 days
Placebo will be administered as oral suspensions QD over 14 days
PF-07328948 will be administered as oral suspensions every 12 hour (BID) or everyday (QD) over 14 days
Placebo will be administered as oral suspensions every 12 hour (BID) or everyday (QD) over 14 days
PF-07328948 will be administered as oral suspensions QD over 14 days
Placebo will be administered as oral suspensions QD over 14 days
PF-07328948 will be administered as oral suspensions every 12 hour (BID) or daily (QD) over 14 days
Placebo will be administered as oral suspensions every 12 hour (BID) or daily (QD) over 14 days
Single doses of PF-07328948 will be administered as oral suspension (single dose) and oral tablet (single dose) under fed and fasted condition
PF-07328948 will be administered as oral suspensions QD over 14 days
Placebo will be administered as oral suspensions QD over 14 days
PF-07328948 will be administered as oral suspensions every 12 hour (BID) or daily (QD) over 14 days
Placebo will be administered as oral suspensions every 12 hour (BID) or daily (QD) over 14 days
PF-07328948 will be administered as oral suspensions every 12 hour (BID) or daily (QD) over 14 days
New Haven Clinical Research Unit
New Haven, Connecticut, United States
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium
Part A: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: Baseline up to 35 days after last dose of study intervention (approximately 11 weeks)
Part A: Number of Participants With Clinical Laboratory Abnormalities
Time frame: Baseline up to 10 days after last dose of study intervention (approximately 7 weeks).
Part A: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline up to 10 days after last dose of study intervention (approximately 7 weeks)
Part A: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Time frame: Baseline up to 10 days after last dose of study intervention (approximately 7 weeks)
Part A: Number of Participants With Change From Baseline in Physical Examination Findings
Time frame: Baseline up to 10 days after last dose of study intervention (approximately 7 weeks)
Part A: Number of Participants With Cardiac Rhythms of Potential Clinical Concern Assessed By Telemetry
Time frame: 0 to 8 hours post-dose on Day 1
Part A: Number of Participants With Cardiac Rhythms of Potential Clinical Concern Assessed By Telemetry
Time frame: 0 to 8 hours post-dose on Day 14
Part B: Maximum Observed Plasma Concentration (Cmax) of PF-07328948 Tablet Formation and Oral Suspension
Time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post dose on Day 1
Part B: Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07328948 Tablet Formation and Oral Suspension
Time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post dose on Day 1
Part B: Area Under the Plasma Concentration-time Curve from Time 0 to Extrapolated Infinite Time (AUCinf) of PF-07328948 Tablet Formation and Oral Suspension
Time frame: Predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post dose on Day 1
Part A: Maximum Observed Plasma Concentration (Cmax) of PF-07328948
Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 38, and 72 hours post dose on Day 1
Part A: Maximum Observed Plasma Concentration (Cmax) of PF-07328948
Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 38, and 72 hours post dose on Day 14
Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to Dosing Interval (tau) (AUCtau) of PF-07328948
Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 38, and 72 hours post dose on Day 1
Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to Dosing Interval (tau) (AUCtau) of PF-07328948
Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 38, and 72 hours post dose on Day 14
Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07328948
Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 38, and 72 hours post dose on Day 1
Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07328948
Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 38, and 72 hours post dose on Day 14
Part A: Amount of PF-07328948 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau)
Time frame: On Day 14, urine collection for PK to occur over 0-tau, according to dosing frequency (ie, 0-12 hours for 12 hour dosing interval; 0-24 hours for 24 hour dosing interval)
Part A: Percentage of Dose of PF-07328948 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%)
Time frame: On Day 14, urine collection for PK to occur over 0-tau, according to dosing frequency (ie, 0-12 hours for 12 hour dosing interval; 0-24 hours for 24 hour dosing interval)
Part A: Renal Clearance of PF-07328948
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Time frame: On Day 14, urine collection for PK to occur over 0-tau, according to dosing frequency (ie, 0-12 hours for 12 hour dosing interval; 0-24 hours for QD dosing interval)
Part B: Maximum Observed Plasma Concentration (Cmax) of PF-07328948 Tablet Formation Under Fasted and Fed Condition
Time frame: predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post dose on Day 1
Part B: Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07328948 Tablet Formation Under Fasted and Fed Condition
Time frame: predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post dose on Day 1
Part B: Area Under the Plasma Concentration-time Curve from Time 0 to Extrapolated Infinite Time (AUCinf) of PF-07328948 Tablet Formation Under Fasted and Fed Condition
Time frame: predose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post dose on Day 1
Part B: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: Baseline up to 35 days post dose of study intervention
Part B: Number of Participants With Clinical Laboratory Abnormalities
Time frame: Baseline up to 4 days post dose of study intervention
Part B: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline up to 4 days post dose of study intervention
Part B: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Time frame: Baseline up to 4 days post dose of study intervention
Part B: Number of Participants With Clinically-Significant Change From Baseline in Physical Examination Findings
Time frame: Baseline up to 35 days post dose of study intervention
Part B: % of administered dose excreted in urine at each specified time interval
Time frame: Days 1 to 11 at 24-hour intervals post-dose
Part B: Total % of PF-07328948 dose recovered in urine
Time frame: Days 1 to 11 at 24-hour intervals post-dose
Part B: % of administered PF-07328948 dose excreted in feces at each specified time interval
Time frame: Days 1 to 11 at 24-hour intervals post-dose
Part B: Total % of PF-07328948 dose recovered in feces
Time frame: Days 1 to 11 at 24-hour intervals post-dose