Trial Outcomes & Findings for A Study to Learn About the Study Medicine Called Nirmatrelvir/Ritonavir in People Who Are Healthy Volunteers Co-administered the Medicine Rosuvastatin (NCT NCT05898672)
NCT ID: NCT05898672
Last Updated: 2024-10-28
Results Overview
COMPLETED
PHASE1
12 participants
Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2
2024-10-28
Participant Flow
A total of 12 healthy male and/or female participants were enrolled in the study.
Participant milestones
| Measure |
Rosuvastatin Then Rosuvastatin + Nirmatrelvir/ Ritonavir
Period 1: Participants received a single oral dose of rosuvastatin 10 milligram (mg) on Day 1 of Period 1 in the morning (AM dose). Period 1 was followed by Period 2. Period 2: Participants received nirmatrelvir 100 mg and ritonavir 100 mg every 12 hours (BID) for 2 days (Day 1 of Period 2: morning \[AM\] and evening \[PM\]; Day 2 of Period 2: morning \[AM\]; total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning (AM dose). Participants were followed-up to a maximum of 35 days from final dose of study intervention.
|
|---|---|
|
Treatment Period 1 (Day -1 up to Day 5)
STARTED
|
12
|
|
Treatment Period 1 (Day -1 up to Day 5)
COMPLETED
|
12
|
|
Treatment Period 1 (Day -1 up to Day 5)
NOT COMPLETED
|
0
|
|
Treatment Period 2 (Day 1 up to Day 5)
STARTED
|
12
|
|
Treatment Period 2 (Day 1 up to Day 5)
COMPLETED
|
12
|
|
Treatment Period 2 (Day 1 up to Day 5)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Learn About the Study Medicine Called Nirmatrelvir/Ritonavir in People Who Are Healthy Volunteers Co-administered the Medicine Rosuvastatin
Baseline characteristics by cohort
| Measure |
Rosuvastatin Then Rosuvastatin + Nirmatrelvir/ Ritonavir
n=12 Participants
Period 1: Participants received a single oral dose of rosuvastatin 10 milligram (mg) on Day 1 of Period 1 in the morning (AM dose). Period 1 was followed by Period 2. Period 2: Participants received nirmatrelvir 100 mg and ritonavir 100 mg every 12 hours (BID) for 2 days (Day 1 of Period 2: morning \[AM\] and evening \[PM\]; Day 2 of Period 2: morning \[AM\]; total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning (AM dose). Participants were followed-up to a maximum of 35 days from final dose of study intervention.
|
|---|---|
|
Age, Continuous
|
36.75 Years
STANDARD_DEVIATION 11.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2Population: Pharmacokinetic (PK) parameter set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Period 1: Rosuvastatin 10 mg
n=11 Participants
Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning.
|
Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg
n=11 Participants
Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning.
|
|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of Rosuvastatin in Period 1 and 2
|
58.62 Nanogram*hour per milliliter
Geometric Coefficient of Variation 46
|
72.78 Nanogram*hour per milliliter
Geometric Coefficient of Variation 48
|
PRIMARY outcome
Timeframe: Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2Population: PK parameter set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.
Outcome measures
| Measure |
Period 1: Rosuvastatin 10 mg
n=12 Participants
Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning.
|
Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg
n=12 Participants
Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning.
|
|---|---|---|
|
Maximum Observed Concentration (Cmax) of Rosuvastatin in Period 1 and 2
|
5.691 Nanogram per milliliter
Geometric Coefficient of Variation 66
|
12.09 Nanogram per milliliter
Geometric Coefficient of Variation 60
|
SECONDARY outcome
Timeframe: Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2Population: PK parameter set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.
Outcome measures
| Measure |
Period 1: Rosuvastatin 10 mg
n=12 Participants
Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning.
|
Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg
n=12 Participants
Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Rosuvastatin in Period 1 and 2
|
51.27 Nanogram*hour per milliliter
Geometric Coefficient of Variation 61
|
71.13 Nanogram*hour per milliliter
Geometric Coefficient of Variation 47
|
SECONDARY outcome
Timeframe: Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2Population: PK parameter set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.
Outcome measures
| Measure |
Period 1: Rosuvastatin 10 mg
n=12 Participants
Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning.
|
Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg
n=12 Participants
Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning.
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|---|---|---|
|
Time for Cmax (Tmax) of Rosuvastatin in Period 1 and 2
|
5.00 Hours
Interval 3.0 to 5.1
|
2.00 Hours
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2Population: PK parameter set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure.
t1/2 was calculated as loge (2) per kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Period 1: Rosuvastatin 10 mg
n=11 Participants
Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning.
|
Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg
n=11 Participants
Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning.
|
|---|---|---|
|
Terminal Half-Life (t1/2) of Rosuvastatin in Period 1 and 2
|
16.37 Hours
Standard Deviation 6.0655
|
24.69 Hours
Standard Deviation 8.2690
|
SECONDARY outcome
Timeframe: Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2Population: PK parameter set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Outcome measures
| Measure |
Period 1: Rosuvastatin 10 mg
n=11 Participants
Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning.
|
Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg
n=11 Participants
Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning.
|
|---|---|---|
|
Apparent Clearance (CL/F) of Rosuvastatin in Period 1 and 2
|
170.6 Liter per hour
Geometric Coefficient of Variation 46
|
137.4 Liter per hour
Geometric Coefficient of Variation 48
|
SECONDARY outcome
Timeframe: Period 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1; Period 2: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose on Day 2Population: PK parameter set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported. Here, "Number of Participants analyzed" signifies number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Period 1: Rosuvastatin 10 mg
n=11 Participants
Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning.
|
Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg
n=11 Participants
Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning.
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|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Rosuvastatin in Period 1 and 2
|
3828 Liter
Geometric Coefficient of Variation 53
|
4685 Liter
Geometric Coefficient of Variation 59
|
SECONDARY outcome
Timeframe: Days 1 and 3 of each periodPopulation: Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Vital signs included blood pressure, pulse rate and temperature. Temperature was measured by orally. Blood pressure was measured with the participant in a supine position after 5 minutes of rest for the participant. Clinically significant findings were determined by the investigator.
Outcome measures
| Measure |
Period 1: Rosuvastatin 10 mg
n=12 Participants
Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning.
|
Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg
n=12 Participants
Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning.
|
|---|---|---|
|
Number of Participants With Clinically Significant Findings in Vital Signs
Day 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Findings in Vital Signs
Day 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)Population: Safety analysis set included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Laboratory abnormalities criteria: a) Hematology: monocytes \>1.2\* upper limit of normal (ULN); b) Urinalysis: urine hemoglobin were \>=1 and leukocyte esterase were \>=1.
Outcome measures
| Measure |
Period 1: Rosuvastatin 10 mg
n=12 Participants
Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning.
|
Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg
n=12 Participants
Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning.
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)Population: Safety analysis set consisted of all participants who received at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
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. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Period 1: Rosuvastatin 10 mg
n=12 Participants
Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning.
|
Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg
n=12 Participants
Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning.
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|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
5 Participants
|
10 Participants
|
Adverse Events
Period 1: Rosuvastatin 10 mg
Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Period 1: Rosuvastatin 10 mg
n=12 participants at risk
Participants received a single dose of rosuvastatin 10 mg on Day 1 of Period 1 in the morning.
|
Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg
n=12 participants at risk
Participants received nirmatrelvir 300 mg and ritonavir 100 mg BID for 2 days (Day 1 of Period 2: morning and evening and Day 2 of Period 2: morning, total 3 doses) along with a single oral administration of rosuvastatin 10 mg on Day 2 of Period 2 in the morning.
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|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
8.3%
1/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
0.00%
0/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
8.3%
1/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
8.3%
1/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
83.3%
10/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
0.00%
0/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
|
Renal and urinary disorders
Pollakiuria
|
8.3%
1/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
0.00%
0/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
8.3%
1/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
|
Vascular disorders
Haematoma
|
33.3%
4/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 days)
|
0.00%
0/12 • Day 1 of dosing up to 35 days up to last dose of study intervention (maximum of 45 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 publication 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