Trial Outcomes & Findings for Food Effect Study to Evaluate the Effect of High-Fat Meal on the Relative Bioavailability of PF-07321332 Boosted With Ritonavir in Healthy Adult Participants (NCT NCT05129475)
NCT ID: NCT05129475
Last Updated: 2023-10-05
Results Overview
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration was determined by linear/log trapezoidal method and reported in this outcome measure.
COMPLETED
PHASE1
12 participants
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2
2023-10-05
Participant Flow
A total of 12 healthy participants signed the informed consent form (ICF) and were enrolled in the study. All of them received the study treatment.
Participant milestones
| Measure |
PF-07321332 Fasted + Ritonavir Then PF-07321332 Fed + Ritonavir
Period 1: Participants received a single oral dose of PF-07321332 300 milligram (mg) (2 tablets of 150 mg each) on Day 1 and 3 doses of ritonavir 100 mg at -12 hour (Day -1), 0 hour and 12 hour (Day 1) related to PF-07321332 dosing under fasted conditions in Period 1 and serial pharmacokinetic (PK) samples were collected up to 48 hours post dose (study Day 3). Period 2: Period 2 started on study Day 4 (Day -1 of Period 2). Participants received a single oral dose of PF-07321332 300 mg on Day 1 (study Day 5) and 3 doses of ritonavir 100 mg at -12 hour (Day -1), 0 hour and 12 hour (Day 1) related to PF-07321332 dosing under fed conditions and PK samples collected up to 48 hours post dose (study Day 7). A minimum of 4 days washout period was present between the PF-07321332 dosing of Period 1 and Period 2. Participants were followed up to maximum of 35 days after the last administration of study drug.
|
PF-07321332 Fed + Ritonavir Then PF-07321332 Fasted + Ritonavir
Period 1: Participants received a single oral dose of PF-07321332 300 mg (2 tablets of 150 mg each) on Day 1 and 3 doses of ritonavir 100 mg at -12 hour (Day -1), 0 hour and 12 hour (Day 1) related to PF-07321332 dosing under fed conditions in Period 1 and serial PK samples were collected up to 48 hours post dose (study Day 3). Period 2: Period 2 started on study Day 4 (Day -1 of Period 2). Participants received a single oral dose of PF-07321332 300 mg on Day 1 (study Day 5) and 3 doses of ritonavir 100 mg at -12 hour (Day -1) , 0 hour and 12 hour (Day 1) related to PF-07321332 dosing under fasted conditions and PK samples collected up to 48 hours post dose (study Day 7). A minimum of 4 days washout period was present between the PF-07321332 dosing of Period 1 and Period 2. Participants were followed up to maximum of 35 days after the last administration of study drug.
|
|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
|
Period 1
COMPLETED
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period
STARTED
|
6
|
6
|
|
Washout Period
COMPLETED
|
6
|
6
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
6
|
6
|
|
Period 2
COMPLETED
|
6
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Food Effect Study to Evaluate the Effect of High-Fat Meal on the Relative Bioavailability of PF-07321332 Boosted With Ritonavir in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
PF-07321332 Fasted + Ritonavir Then PF-07321332 Fed + Ritonavir
n=6 Participants
Period 1: Participants received a single oral dose of PF-07321332 300 mg (2 tablets of 150 mg each) on Day 1 and 3 doses of ritonavir 100 mg at -12 hour (Day -1), 0 hour and 12 hour (Day 1) related to PF-07321332 dosing under fasted conditions in Period 1 and serial PK samples were collected up to 48 hours post dose (study Day 3). Period 2: Period 2 started on study Day 4 (Day -1 of Period 2). Participants received a single oral dose of PF-07321332 300 mg on Day 1 (study Day 5) and 3 doses of ritonavir 100 mg at -12 hour (Day -1), 0 hour and 12 hour (Day 1) related to PF-07321332 dosing under fed conditions and PK samples collected up to 48 hours post dose (study Day 7). A minimum of 4 days washout period was present between the PF-07321332 dosing of Period 1 and Period 2. Participants were followed up to maximum of 35 days after the last administration of study drug.
|
PF-07321332 Fed + Ritonavir Then PF-07321332 Fasted + Ritonavir
n=6 Participants
Period 1: Participants received a single oral dose of PF-07321332 300 mg (2 tablets of 150 mg each) on Day 1 and 3 doses of ritonavir 100 mg at -12 hour (Day -1), 0 hour and 12 hour (Day 1) related to PF-07321332 dosing under fed conditions in Period 1 and serial PK samples were collected up to 48 hours post dose (study Day 3). Period 2: Period 2 started on study Day 4 (Day -1 of Period 2). Participants received a single oral dose of PF-07321332 300 mg on Day 1 (study Day 5) and 3 doses of ritonavir 100 mg at -12 hour (Day -1) , 0 hour and 12 hour (Day 1) related to PF-07321332 dosing under fasted conditions and PK samples collected up to 48 hours post dose (study Day 7). A minimum of 4 days washout period was present between the PF-07321332 dosing of Period 1 and Period 2. Participants were followed up to maximum of 35 days after the last administration of study drug.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.7 Years
STANDARD_DEVIATION 13.06 • n=99 Participants
|
40.2 Years
STANDARD_DEVIATION 13.03 • n=107 Participants
|
46.9 Years
STANDARD_DEVIATION 14.30 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2Population: The PK parameter analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest.
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration was determined by linear/log trapezoidal method and reported in this outcome measure.
Outcome measures
| Measure |
PF-07321332 300 mg/Ritonavir 100 mg Fed
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
PF-07321332 300 mg/Ritonavir 100 mg Fasted
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07321332
|
43360 Nanogram*hour per milliliter
Geometric Coefficient of Variation 31
|
35860 Nanogram*hour per milliliter
Geometric Coefficient of Variation 35
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2Population: The PK parameter analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest.
AUCinf was calculated by AUClast + (Clast/kel). AUClast was the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). 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 |
PF-07321332 300 mg/Ritonavir 100 mg Fed
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
PF-07321332 300 mg/Ritonavir 100 mg Fasted
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332
|
44050 Nanogram*hour per milliliter
Geometric Coefficient of Variation 31
|
36810 Nanogram*hour per milliliter
Geometric Coefficient of Variation 36
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2Population: The PK parameter analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest.
Cmax was defined as maximum observed plasma concentration. It was observed directly from data.
Outcome measures
| Measure |
PF-07321332 300 mg/Ritonavir 100 mg Fed
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
PF-07321332 300 mg/Ritonavir 100 mg Fasted
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-07321332
|
5951 Nanogram per milliliter
Geometric Coefficient of Variation 31
|
3696 Nanogram per milliliter
Geometric Coefficient of Variation 44
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2Population: The PK parameter analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest.
Tmax was defined as the time to reach maximum observed plasma concentration of PF-07321332.
Outcome measures
| Measure |
PF-07321332 300 mg/Ritonavir 100 mg Fed
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
PF-07321332 300 mg/Ritonavir 100 mg Fasted
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332
|
2.50 Hours
Interval 1.5 to 4.0
|
2.29 Hours
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2Population: The PK parameter analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest.
t1/2 was calculated by Loge(2)/kel. kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.
Outcome measures
| Measure |
PF-07321332 300 mg/Ritonavir 100 mg Fed
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
PF-07321332 300 mg/Ritonavir 100 mg Fasted
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
|---|---|---|
|
Terminal Elimination Half-life (t1/2) of PF-07321332
|
7.390 Hours
Standard Deviation 2.5843
|
8.673 Hours
Standard Deviation 3.3768
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2Population: The PK parameter analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent clearance) is influenced by the fraction of the dose absorbed. CL/F was calculated as dose/AUCinf.
Outcome measures
| Measure |
PF-07321332 300 mg/Ritonavir 100 mg Fed
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
PF-07321332 300 mg/Ritonavir 100 mg Fasted
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
|---|---|---|
|
Apparent Clearance (CL/F) of PF-07321332 From Plasma
|
6.812 Liters per hour
Geometric Coefficient of Variation 31
|
8.148 Liters per hour
Geometric Coefficient of Variation 36
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2Population: The PK parameter analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and who had at least 1 of the PK parameters of interest.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Vz/F was calculated as dose/(AUCinf\*kel). kel was the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.
Outcome measures
| Measure |
PF-07321332 300 mg/Ritonavir 100 mg Fed
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
PF-07321332 300 mg/Ritonavir 100 mg Fasted
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of PF-07321332
|
68.77 Liters
Geometric Coefficient of Variation 41
|
96.88 Liters
Geometric Coefficient of Variation 38
|
SECONDARY outcome
Timeframe: Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE which resulted in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to maximum of 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
PF-07321332 300 mg/Ritonavir 100 mg Fed
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
PF-07321332 300 mg/Ritonavir 100 mg Fasted
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
6 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day -1 of Period 1 up to Day 3 of Period 2 (maximum of 8 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Clinical laboratory abnormalities included following criteria: a) hematology evaluation included eosinophils/leukocytes greater than (\>) 1.2\* upper limit of normal (ULN), monocytes/leukocytes \>1.2\*ULN; b) clinical chemistry evaluation included urobilinogen greater than or equal to (\>=) 1, fibrinogen \>1.25\*baseline; c) urinalysis evaluation included urine hemoglobin \>=1.
Outcome measures
| Measure |
PF-07321332 300 mg/Ritonavir 100 mg Fed
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
PF-07321332 300 mg/Ritonavir 100 mg Fasted
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose) of Period 1 up to Day 3 of Period 2 (maximum of 7 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Vital signs evaluations included supine blood pressure (BP) and pulse rate. The pre specified criteria for vital signs included systolic blood pressure (BP) minimum (min.) less than (\<) 90 millimeter of mercury (mmHg); systolic BP change from baseline maximum (max.) decrease \>= 30 mmHg, max. increase \>=30 mmHg; diastolic BP min. \<50mmHg; diastolic BP change from baseline max. decrease \>=20, max. increase \>=20; supine pulse rate min. \<40 beats per minute (bpm) and max. \>120 bpm.
Outcome measures
| Measure |
PF-07321332 300 mg/Ritonavir 100 mg Fed
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
PF-07321332 300 mg/Ritonavir 100 mg Fasted
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
|---|---|---|
|
Number of Participants Meeting Pre-Specified Criteria for Vital Signs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose) of Period 1 up to Day 3 of Period 2 (maximum of 7 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
A 12-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QT, and QTc intervals and QRS complex. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position. The pre specified criteria for ECG values included absolute value of QTCF (Fridericia's correction formula): \>=450 to less than or equal to (\<=) 480 milliseconds, \>480 to \<=500 milliseconds, \>500 milliseconds, increase from baseline \>30 - \<=60, increase from baseline \>60. PR interval: \>=300 milliseconds, increase from baseline: baseline \>200 milliseconds and max. increase \>=25% and baseline \<=200 milliseconds and max. increase \>=50%; QRS duration: \>=140 milliseconds, increase from baseline \>=50%.
Outcome measures
| Measure |
PF-07321332 300 mg/Ritonavir 100 mg Fed
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
PF-07321332 300 mg/Ritonavir 100 mg Fasted
n=12 Participants
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
|---|---|---|
|
Number of Participants Meeting Pre-Specified Criteria for 12-Lead Electrocardiogram (ECG) Values
|
0 Participants
|
0 Participants
|
Adverse Events
PF-07321332 300 mg/Ritonavir 100 mg Fed
PF-07321332 300 mg/Ritonavir 100 mg Fasted
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-07321332 300 mg/Ritonavir 100 mg Fed
n=12 participants at risk
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fed conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
PF-07321332 300 mg/Ritonavir 100 mg Fasted
n=12 participants at risk
Participants received a single oral dose of PF-07321332 300 mg on Day 1 and 3 doses of 100 mg ritonavir at -12 hours (Day -1), 0 hours and 12 hours (Day 1) related to PF-07321332 dosing in either Period 1 or Period 2 under fasted conditions. Participants were followed up to maximum of 35 days after the last dose of study drug.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days)
|
8.3%
1/12 • Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days)
|
|
Infections and infestations
COVID-19
|
8.3%
1/12 • Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days)
|
0.00%
0/12 • Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days)
|
8.3%
1/12 • Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/12 • Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days)
|
8.3%
1/12 • Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days)
|
|
Nervous system disorders
Dysgeusia
|
41.7%
5/12 • Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days)
|
25.0%
3/12 • Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/12 • Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days)
|
8.3%
1/12 • Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days)
|
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