Trial Outcomes & Findings for A Study to Learn About the Study Medicine PF-07321332 and Ritonavir in Adult Healthy Chinese Participants. (NCT NCT05339334)
NCT ID: NCT05339334
Last Updated: 2024-10-08
Results Overview
Cmax is maximum plasma concentration .
COMPLETED
PHASE1
14 participants
Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)
2024-10-08
Participant Flow
The study consisted of 1 treatment group: multiple oral doses of PF-07321332300 mg/ritonavir 100 mg. A total of 14 healthy participants were enrolled and treated.
Participant milestones
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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Overall Study
STARTED
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14
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Overall Study
COMPLETED
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14
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Learn About the Study Medicine PF-07321332 and Ritonavir in Adult Healthy Chinese Participants.
Baseline characteristics by cohort
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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Age, Continuous
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33.1 years
STANDARD_DEVIATION 6.78 • n=5 Participants
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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14 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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14 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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0 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Cmax is maximum plasma concentration .
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1
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3082 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 29
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PRIMARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Cmax is maximum plasma concentration
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 10
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4500 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 14
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PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Tmax is the time for maximum plasma concentration
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 1
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1.76 hours (hr)
Interval 1.0 to 4.0
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PRIMARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Tmax is the time for maximum plasma concentration
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 10
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2.00 hours (hr)
Interval 1.0 to 4.02
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PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Area under the plasma concentration-time profile from time Zero to time point on 12 hours
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1
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19660 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
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PRIMARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours) (AUCtau) on Day 10
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32010 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 21
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PRIMARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
This was determined by AUCtau/tau.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10
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2668 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21
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PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Accumulation ratio for AUCtau following multiple dosing was calculated as AUCtau on Day 10 divided by AUC12 on Day 1.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Accumulation Ratio for AUCtau (Rac) on Day 10
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1.627 ratio
Geometric Coefficient of Variation 21
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PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Observed accumulation ratio for Cmax was calculated as Cmax on Day 10 divided by Cmax on Day 1.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Accumulation Ratio for Cmax (Rac, Cmax) on Day 10
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1.461 ratio
Geometric Coefficient of Variation 22
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PRIMARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
This was determined by Day 10 Cmax/Day 10 Ctrough.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Peak-to-trough Ratio (PTR) on Day 10
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4.517 ratio
Geometric Coefficient of Variation 32
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PRIMARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Apparent oral clearance. This was determined by Dose/AUCtau.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Apparent Clearance (CL/F) on Day 10
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9.379 Liter/hour (L/h)
Geometric Coefficient of Variation 21
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PRIMARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Apparent oral volume of distribution.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Apparent Volume of Distribution (Vz/F) on Day 10
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91.01 Liters (L)
Geometric Coefficient of Variation 29
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PRIMARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Terminal half-life. This was determined by Loge(2)/kel, where kel is 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
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Terminal Elimination Half-life (t½) on Day 10
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6.842 Hours (hr)
Standard Deviation 1.2336
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PRIMARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10
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41460 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 24
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PRIMARY outcome
Timeframe: Day 5 (pre-dose)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Concentration at pre-dose on Day 5. Observed directly from data.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Trough Concentration (Ctrough) on Day 5
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1389 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 26
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PRIMARY outcome
Timeframe: Day 8 (pre-dose)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Concentration at pre-dose on Day 8. Observed directly from data.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Trough Concentration (Ctrough) on Day 8
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1481 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 27
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PRIMARY outcome
Timeframe: Day 10 (pre-dose)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Concentration at pre-dose on Day 10. Observed directly from data.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Trough Concentration (Ctrough) on Day 10 (Pre-dose)
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1333 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 32
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PRIMARY outcome
Timeframe: Day 10 (12 hours after last dose)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Concentration at 12 hour time on Day 10. Observed directly from data.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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PF-07321332 Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)
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997.4 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40
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SECONDARY outcome
Timeframe: From baseline up to Day 42Population: The analysis population included all participants who took at least 1 dose of study intervention.
An adverse event (AE) is any untoward medical occurrence in a patient 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. An adverse event is considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study would be flagged as TEAEs.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs
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6 Participants
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
serious TEAEs
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0 Participants
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SECONDARY outcome
Timeframe: Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)Population: The analysis population included all participants 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; seated pulse rate min. \<40 beats per minute (bpm) and max. \>120 bpm. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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Number of Participants With Vital Signs Data Meeting Pre-Specified Categorization Criteria
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0 Participants
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SECONDARY outcome
Timeframe: Day-1, Day 2, Day 5, Day 8, Day 10, Day 12.Population: The analysis population included all participants who took at least 1 dose of study intervention.
Safety laboratory assessments included hematology, urinalysis, and clinical chemistry.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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|---|---|
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Number of Participants With Laboratory Abnormalities
Urate (milligrams per decilitre[mg/dL]) > 1.2x upper limit of normal (ULN)
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2 Participants
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Number of Participants With Laboratory Abnormalities
Fibrinogen (mg/dL) < 0.75x Baseline
|
1 Participants
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Number of Participants With Laboratory Abnormalities
Fibrinogen (mg/dL) > 1.25x Baseline
|
2 Participants
|
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Number of Participants With Laboratory Abnormalities
Urine Hemoglobin ≥ 1
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)Population: The analysis population included all participants who took at least 1 dose of study intervention.
The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average of the triplicate pre-dose recordings on Day 1. Pre-defined categories for corrected QT (Fridericia method) (QTcF): Absolute value (milliseconds\[msec\]) \>450 and ≤480, or \>480 and ≤500, or \>500; Increase from baseline in QTcF (msec) \>30 and ≤60, or\>60. Pre-defined categories for PR and QRS: PR (msec) max. ≥300; PR (msec) increase from baseline: baseline \>200 and max. ≥25% increase, or baseline ≤200 and max. ≥50% increase; QRS (msec) max. ≥140; QRS (msec) increase from baseline ≥50% increase. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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|---|---|
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Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Categorization Criteria
|
0 Participants
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SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Cmax is maximum plasma concentration
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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|---|---|
|
Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 1
|
545.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
SECONDARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Cmax is maximum plasma concentration
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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|---|---|
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Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 10
|
1109 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Tmax is the time for maximum plasma concentration
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
|
|---|---|
|
Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 1
|
2.00 hours (hr)
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Tmax is the time for maximum plasma concentration
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
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|---|---|
|
Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 10
|
2.00 hours (hr)
Interval 1.5 to 4.0
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
This was determined by linear/Log trapezoidal method - reported as AUC12 on Day 1.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
|
|---|---|
|
Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1
|
3136 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 49
|
SECONDARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
|
|---|---|
|
Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours [Twice Daily Dosing]) (AUCtau) on Day 10
|
6152 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 29
|
SECONDARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
|
|---|---|
|
Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10
|
7118 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 33
|
SECONDARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
This was determined by AUCtau/tau.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
|
|---|---|
|
Ritonavir Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10
|
512.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 29
|
SECONDARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Apparent oral clearance. This was determined by Dose/AUCtau.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
|
|---|---|
|
Ritonavir Apparent Clearance (CL/F) on Day 10
|
16.25 Liter/hour (L/h)
Geometric Coefficient of Variation 29
|
SECONDARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Apparent oral volume of distribution. This was determined by Dose/(AUCtau\*kel)
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
|
|---|---|
|
Ritonavir Apparent Volume of Distribution (Vz/F) on Day 10
|
123.0 Liters (L)
Geometric Coefficient of Variation 23
|
SECONDARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Terminal half-life. This was determined by Loge(2)/kel, where kel is 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
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
|
|---|---|
|
Ritonavir Terminal Elimination Half-life (t½) on Day 10
|
5.471 Hours (hr)
Standard Deviation 1.7871
|
SECONDARY outcome
Timeframe: Day 5 (pre-dose)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Concentration at pre-dose on Day 5. Observed directly from data.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
|
|---|---|
|
Ritonavir Trough Concentration (Ctrough) on Day 5
|
233.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
SECONDARY outcome
Timeframe: Day 8 (pre-dose)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Concentration at pre-dose on Day 8. Observed directly from data.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
|
|---|---|
|
Ritonavir Trough Concentration (Ctrough) on Day 8
|
212.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
SECONDARY outcome
Timeframe: Day 10 (pre-dose)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Concentration at pre-dose on Day 10. Observed directly from data.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
|
|---|---|
|
Ritonavir Trough Concentration (Ctrough) on Day 10 (Pre-dose)
|
200.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
SECONDARY outcome
Timeframe: Day 10 (12 hours after last dose)Population: The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Concentration at 12 hour on Day 10. Observed directly from data.
Outcome measures
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 Participants
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
|
|---|---|
|
Ritonavir Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)
|
134.9 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
Adverse Events
PF-07321332 300 mg + Ritonavir 100 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-07321332 300 mg + Ritonavir 100 mg
n=14 participants at risk
The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
4/14 • From baseline up to Day 42.
The adverse events were reported by the treatment group of PF-07321332 300 mg + Ritonavir 100 mg, instead of by 2 treatment groups separately as PF-07321332 and ritonavir were dosed simultaneously (within no more than 5 minutes of each other).
|
|
Investigations
Blood creatinine increased
|
7.1%
1/14 • From baseline up to Day 42.
The adverse events were reported by the treatment group of PF-07321332 300 mg + Ritonavir 100 mg, instead of by 2 treatment groups separately as PF-07321332 and ritonavir were dosed simultaneously (within no more than 5 minutes of each other).
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • From baseline up to Day 42.
The adverse events were reported by the treatment group of PF-07321332 300 mg + Ritonavir 100 mg, instead of by 2 treatment groups separately as PF-07321332 and ritonavir were dosed simultaneously (within no more than 5 minutes of each other).
|
|
Nervous system disorders
Dysgeusia
|
28.6%
4/14 • From baseline up to Day 42.
The adverse events were reported by the treatment group of PF-07321332 300 mg + Ritonavir 100 mg, instead of by 2 treatment groups separately as PF-07321332 and ritonavir were dosed simultaneously (within no more than 5 minutes of each other).
|
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