Trial Outcomes & Findings for Relative Bioavailability Study of 4 Different Formulations of PF-07321332 Relative to the Commercial Tablet Formulation (NCT NCT05263895)
NCT ID: NCT05263895
Last Updated: 2025-06-11
Results Overview
AUClast for nirmatrelvir was calculated by Linear/Log trapezoidal method. Natural log-transformed AUClast for nirmatrelvir (slower dissolution tablets and large particle size tablets) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Natural log-transformed AUClast for Nirmatrelvir (SDD suspension) was analyzed using a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours postdose
Results posted on
2025-06-11
Participant Flow
Twelve participants were enrolled to 1 of 6 sequences. Each participant participated in 5 study periods to receive 5 treatments: Treatment A: nirmatrelvir (commercial tablets)/ritonavir 300/100 mg; Treatment B: nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg; Treatment C: nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg; Treatment D: nirmatrelvir (spray dried dispersion \[SDD\] suspension)/ritonavir 300/100 mg; Treatment E: nirmatrelvir 300 mg (SDD suspension)
Participant milestones
| Measure |
Sequence 1
Twelve participants were randomly assigned to 1 of 6 sequences. Each sequence included 2 participants who received 5 study treatments in 5 study periods.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 1.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 2.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 3.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 4.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours) in Period 5.
|
Sequence 2
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 1.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 2.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 3.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 4.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours) in Period 5.
|
Sequence 3
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 1.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 2.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 3.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 4.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours) in Period 5.
|
Sequence 4
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 1.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 2.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 3.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours) in Period 4.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 5.
|
Sequence 5
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 1.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 2.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 3.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours) in Period 4.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 5.
|
Sequence 6
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 1.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 2.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 3.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours) in Period 4.
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours) in Period 5.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 1
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
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Period 2
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 3
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 4
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
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0
|
0
|
|
Period 5
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 5
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Relative Bioavailability Study of 4 Different Formulations of PF-07321332 Relative to the Commercial Tablet Formulation
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participants
All participants enrolled in this study, "Enrolled" meant a participant's agreement to participate in a clinical study following completion of the informed consent process and screening. Potential participants who were screened for the purpose of determining eligibility for the study, but did not participate in the study, were not considered enrolled, unless otherwise specified by the protocol. A participant was considered enrolled if the informed consent was not withdrawn prior to participating in any study activity after screening.
|
|---|---|
|
Age, Continuous
|
48.0 Years
n=5 Participants
|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
18-44 years
|
5 Participants
n=5 Participants
|
|
Age, Customized
45-64 years
|
7 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American, White
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours postdosePopulation: 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.
AUClast for nirmatrelvir was calculated by Linear/Log trapezoidal method. Natural log-transformed AUClast for nirmatrelvir (slower dissolution tablets and large particle size tablets) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Natural log-transformed AUClast for Nirmatrelvir (SDD suspension) was analyzed using a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.
Outcome measures
| Measure |
Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension) 300 mg
n=12 Participants
On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (Clast) (AUClast) of Nirmatrelvir
|
35020 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 15
|
31700 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
35990 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
48380 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 15
|
10530 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 50
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours postdosePopulation: 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.
AUCinf for nirmatrelvir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve. Natural log-transformed AUCinf for nirmatrelvir (slower dissolution tablets and large particle size tablets) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Natural log-transformed AUCinf for Nirmatrelvir (SDD suspension) was analyzed using a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.
Outcome measures
| Measure |
Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension) 300 mg
n=12 Participants
On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Nirmatrelvir
|
35540 ng*hr/mL
Geometric Coefficient of Variation 14
|
32430 ng*hr/mL
Geometric Coefficient of Variation 26
|
36420 ng*hr/mL
Geometric Coefficient of Variation 25
|
48680 ng*hr/mL
Geometric Coefficient of Variation 15
|
10580 ng*hr/mL
Geometric Coefficient of Variation 50
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours postdosePopulation: 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.
Cmax for nirmatrelvir was observed directly from data. Natural log-transformed Cmax for nirmatrelvir (slower dissolution tablets and large particle size tablets) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Natural log-transformed Cmax for Nirmatrelvir (SDD suspension) was analyzed using a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.
Outcome measures
| Measure |
Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension) 300 mg
n=12 Participants
On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Nirmatrelvir
|
3347 ng/mL
Geometric Coefficient of Variation 16
|
3155 ng/mL
Geometric Coefficient of Variation 23
|
3635 ng/mL
Geometric Coefficient of Variation 27
|
8840 ng/mL
Geometric Coefficient of Variation 14
|
4871 ng/mL
Geometric Coefficient of Variation 30
|
SECONDARY outcome
Timeframe: Baseline up to 35 days after last dose of study intervention (up to 12 weeks)Population: All participants who took 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 or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs might arise from symptoms or other complaints reported to the investigator by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative), or they might arise from clinical findings of the investigator or other healthcare providers (clinical signs, test results, etc.). TEAEs were those with initial onset or increasing in severity after the first dose of study treatment.
Outcome measures
| Measure |
Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension) 300 mg
n=12 Participants
On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
All-Causality AEs
|
4 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-Related AEs
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Screening (from Day-28 to Day-2), Day-1 of Period 1 (before 1st dose) and Day4 of Period 5 (4 days after the last dose on study discharge day). Each treatment period was 4 days long (Day1 to Day4) with a minimum of 4 days washout between each periodPopulation: Participants with at least 1 observation of the given laboratory test while on study treatment or during lag time.
The laboratory abnormality parameters included Chemistry: bicarbonate (milliequivalents per liter \[mEq/L\]) \<0.9 x lower limit of normal (LLN), urobilinogen (ehrlich units per deciliter \[EU/dL\]) \>=1, and fibrinogen (milligram/deciliter \[mg/dL\]) \>1.25 x baseline; Urinalysis: URINE hemoglobin (Scalar) \>=1, only those categories in which at least 1 participant had data were reported. All the safety laboratory samples were collected following at least a 4 hour fast. Clinical laboratory evaluations only included treatments of nirmatrelvir SDD suspension/ritonavir 300/100 mg and nirmatrelvir SDD suspension 300 mg. No participant was evaluable for clinical laboratory evaluations for the other treatments.
Outcome measures
| Measure |
Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg
n=6 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg
n=6 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension) 300 mg
On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Bicarbonate (mEq/L) <0.9 x LLN
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Urobilinogen (EU/dL) >=1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Fibrinogen (mg/dL) >1.25 x Baseline
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
URINE Hemoglobin (Scalar) >=1
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening (D28-D2), D1 of Period 1 (before 1st dose), D1 hr 0,2,and 6 of each period, and D4 of Period 5 (4 days after the last dose on study discharge day). Each treatment Period was 4 days long (D1-D4) with a minimum 4 days washout between each periodPopulation: All participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Single supine blood pressure (BP) and pulse rate (PR) were measured with the participant's arm supported at the level of the heart and recorded to the nearest mm Hg after approximately 5 minutes of rest. The same arm (preferably the dominant arm) was used throughout the study. Participants were instructed not to speak during measurements.
Outcome measures
| Measure |
Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension) 300 mg
n=12 Participants
On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).
|
|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening (from D-28 to D-2), D1, hr0 of Period 1 (before 1st dose) and D4 of Period 5 (4 days after last dose on study discharge day). Each treatment period was 4 days long (D1 to D4) with a minimum of 4 days washout between each periodPopulation: All participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Standard 12-lead ECGs utilizing limb leads (with a 10 second rhythm strip) were collected. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position.
Outcome measures
| Measure |
Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension) 300 mg
n=12 Participants
On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).
|
|---|---|---|---|---|---|
|
Number of Participants With ECG Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening (from Day-28 to Day-2), Day-1 of Period 1 (before 1st dose. Each treatment period was 4 days long (Day1 to Day4) with a minimum of 4 days washout between each periodPopulation: All participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
A complete PE included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant reported symptoms.
Outcome measures
| Measure |
Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg
n=12 Participants
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension) 300 mg
n=12 Participants
On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).
|
|---|---|---|---|---|---|
|
Number of Participants With Physical Examination Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nirmatrelvir (SDD Suspension) 300 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nirmatrelvir (Commercial Tablets)/Ritonavir 300/100 mg
n=12 participants at risk
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg commercial tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Slower Dissolution Tablets)/Ritonavir 300/100 mg
n=12 participants at risk
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg slower dissolution tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (Large Particle Size Tablets)/Ritonavir 300/100 mg
n=12 participants at risk
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as 2 × 150 mg larger particle size tablets, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension)/Ritonavir 300/100 mg
n=12 participants at risk
On Day 1, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally with ritonavir 100 mg (as 1 × 100 mg tablet) starting at approximately 0800 hours (plus or minus 2 hours).
|
Nirmatrelvir (SDD Suspension) 300 mg
n=12 participants at risk
On Day, following an overnight fast of at least 10 hours, participants received nirmatrelvir 300 mg as SDD suspension, administered orally without ritonavir starting at approximately 0800 hours (plus or minus 2 hours).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
1/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
1/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
4/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
1/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
1/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
1/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Vascular disorders
Haematoma
|
8.3%
1/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
8.3%
1/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/12 • Baseline up to 35 days after last dose of study intervention (up to 12 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place