Trial Outcomes & Findings for Relative Bioavailability Study of PF-07321332/Ritonavir Oral Powder Relative to the Commercial Tablets in Healthy Participants (NCT NCT05263921)
NCT ID: NCT05263921
Last Updated: 2024-06-06
Results Overview
Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
COMPLETED
PHASE1
12 participants
0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
2024-06-06
Participant Flow
This was a phase 1, open label, single dose, randomized, crossover study in healthy adult participants. A total of 12 participants were assigned to the study, participating in 4 study periods to receive 4 different treatments, and 11 participants completed the study and 1 participant discontinued from the study intervention due to family emergency.
Participant milestones
| Measure |
Sequence 1: Treatment A-> B-> C-> D
Treatment A: Nirmatrelvir/ritonavir 300/100 mg commercial tablets. Treatment B: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water. Treatment C: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce.
Treatment D: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding.
All treatments were administered under fasted conditions, and a minimum of 4-day washout was planned between each treatment.
|
Sequence 2: Treatment B-> D-> A-> C
Treatment A: Nirmatrelvir/ritonavir 300/100 mg commercial tablets. Treatment B: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water. Treatment C: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce.
Treatment D: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding.
All treatments were administered under fasted conditions, and a minimum of 4-day washout was planned between each treatment.
|
Sequence 3: Treatment C-> A-> D-> B
Treatment A: Nirmatrelvir/ritonavir 300/100 mg commercial tablets. Treatment B: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water. Treatment C: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce.
Treatment D: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding.
All treatments were administered under fasted conditions, and a minimum of 4-day washout was planned between each treatment.
|
Sequence 4: Treatment D-> C-> B-> A
Treatment A: Nirmatrelvir/ritonavir 300/100 mg commercial tablets. Treatment B: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water. Treatment C: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce.
Treatment D: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding.
All treatments were administered under fasted conditions, and a minimum of 4-day washout was planned between each treatment.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: Treatment A-> B-> C-> D
Treatment A: Nirmatrelvir/ritonavir 300/100 mg commercial tablets. Treatment B: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water. Treatment C: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce.
Treatment D: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding.
All treatments were administered under fasted conditions, and a minimum of 4-day washout was planned between each treatment.
|
Sequence 2: Treatment B-> D-> A-> C
Treatment A: Nirmatrelvir/ritonavir 300/100 mg commercial tablets. Treatment B: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water. Treatment C: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce.
Treatment D: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding.
All treatments were administered under fasted conditions, and a minimum of 4-day washout was planned between each treatment.
|
Sequence 3: Treatment C-> A-> D-> B
Treatment A: Nirmatrelvir/ritonavir 300/100 mg commercial tablets. Treatment B: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water. Treatment C: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce.
Treatment D: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding.
All treatments were administered under fasted conditions, and a minimum of 4-day washout was planned between each treatment.
|
Sequence 4: Treatment D-> C-> B-> A
Treatment A: Nirmatrelvir/ritonavir 300/100 mg commercial tablets. Treatment B: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water. Treatment C: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce.
Treatment D: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding.
All treatments were administered under fasted conditions, and a minimum of 4-day washout was planned between each treatment.
|
|---|---|---|---|---|
|
Overall Study
Other: family emergency.
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Relative Bioavailability Study of PF-07321332/Ritonavir Oral Powder Relative to the Commercial Tablets in Healthy Participants
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participant
All participants enrolled in the study.
|
|---|---|
|
Age, Continuous
|
42.25 Years
STANDARD_DEVIATION 12.800 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 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
|
1 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 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: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each periodPopulation: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.
Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=12 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
|
28670 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 36
|
30780 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 25
|
33170 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 33
|
36020 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 27
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each periodPopulation: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.
Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast) was measured. AUClast was determined by Linear/Log trapezoidal method.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=12 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
|
27790 ng*hr/mL
Geometric Coefficient of Variation 36
|
30230 ng*hr/mL
Geometric Coefficient of Variation 27
|
32180 ng*hr/mL
Geometric Coefficient of Variation 33
|
35580 ng*hr/mL
Geometric Coefficient of Variation 27
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each periodPopulation: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.
Maximum plasma concentration (Cmax) was measured. Cmax was observed directly from data.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=12 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
|
2817 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
3254 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 23
|
4025 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
4572 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 19
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each periodPopulation: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.
Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=12 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
|
4843 ng*hr/mL
Geometric Coefficient of Variation 28
|
5414 ng*hr/mL
Geometric Coefficient of Variation 30
|
4979 ng*hr/mL
Geometric Coefficient of Variation 45
|
5271 ng*hr/mL
Geometric Coefficient of Variation 26
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each periodPopulation: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.
Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast) was measured. AUClast was determined by Linear/Log trapezoidal method.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=12 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
|
4588 ng*hr/mL
Geometric Coefficient of Variation 29
|
5108 ng*hr/mL
Geometric Coefficient of Variation 32
|
4757 ng*hr/mL
Geometric Coefficient of Variation 46
|
4998 ng*hr/mL
Geometric Coefficient of Variation 26
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each periodPopulation: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.
Maximum plasma concentration (Cmax) was measured. Cmax was observed directly from data.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=12 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
|
536.9 ng/mL
Geometric Coefficient of Variation 41
|
598.2 ng/mL
Geometric Coefficient of Variation 42
|
579.8 ng/mL
Geometric Coefficient of Variation 45
|
640.5 ng/mL
Geometric Coefficient of Variation 30
|
SECONDARY outcome
Timeframe: Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.Population: All participants who took at least 1 dose of study intervention.
Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product, without regard to relatedness. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Treatment-related TEAEs were any untoward medical occurrence attributed to study intervention. Relatedness to study intervention was determined by the investigator.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=12 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Event
All-causality TEAEs
|
6 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Event
Treatment-related TEAEs
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Screening, Period 1 Day -1, Period 4 Day 4 and early termination/discontinuation.Population: All participants who took at least 1 dose of study intervention were included in the safety analysis set.
Participants analyzed in the laboratory abnormalities were with at least one observation of the given laboratory test while on study treatment or during lag time. Number of participants with laboratory abnormalities were number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time. Hematology, chemistry, urinalysis and other (SARS-CoV-2 RT-PCR, Urine drug screening, Pregnancy test (β hCG), eGFR \[CKD-EPI\], aPTT, PT-INR, Fibrinogen, At Screening only: FSH, HBsAg, HBsAb, HBcAb, HCVAb, HIV) were assessed.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=3 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=2 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=4 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
n=3 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities
Urinalysis: pH (>8)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Urinalysis: Urine hemoglobin (≥1)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Urinalysis: Nitrite (≥1)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Urinalysis: Leukocyte Esterase (≥1)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening, Day 1 of each period and early termination/discontinuation.Population: All participants who took at least 1 dose of study intervention.
Participants with clinically significant vital sign values were with at least one observation of vital signs, which met pre-specified criteria while on study treatment or during lag time.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=12 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Sign Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening and Period 1 Day -1.Population: All participants who took at least 1 dose of study intervention.
Participants with clinically significant physical examination values were with at least one observation of physical examination, which met pre-specified criteria while on study treatment or during lag time.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=12 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Physical Examination Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening, Period 1 Day 1 and Period 4 Day 4.Population: All participants who took at least 1 dose of study intervention.
Participants with clinically significant electrocardiogram (ECG) values were with at least one observation of ECG, which met pre-specified criteria while on study treatment or during lag time.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=12 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Electrocardiogram Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.Population: All participants who had tasted study interventions (in different vehicles) and made scores on the taste questionnaires were included in this analysis.
Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=12 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
1 min
|
61.3 Units on a scale
Standard Deviation 31.25
|
53.5 Units on a scale
Standard Deviation 28.42
|
49.5 Units on a scale
Standard Deviation 31.30
|
—
|
|
Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
5 min
|
63.2 Units on a scale
Standard Deviation 36.52
|
55.2 Units on a scale
Standard Deviation 32.56
|
57.5 Units on a scale
Standard Deviation 34.18
|
—
|
|
Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
10 min
|
61.2 Units on a scale
Standard Deviation 35.96
|
52.5 Units on a scale
Standard Deviation 38.92
|
51.6 Units on a scale
Standard Deviation 37.29
|
—
|
|
Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
20min
|
60.5 Units on a scale
Standard Deviation 35.06
|
52.0 Units on a scale
Standard Deviation 37.26
|
48.5 Units on a scale
Standard Deviation 35.41
|
—
|
SECONDARY outcome
Timeframe: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.Population: All participants who had tasted study interventions (in different vehicles) and made scores on the taste questionnaires were included in this analysis.
Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=12 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
1 min
|
75.4 Units on a scale
Standard Deviation 27.37
|
69.3 Units on a scale
Standard Deviation 34.39
|
63.2 Units on a scale
Standard Deviation 33.48
|
—
|
|
Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
5 min
|
76.4 Units on a scale
Standard Deviation 29.15
|
65.0 Units on a scale
Standard Deviation 35.46
|
63.2 Units on a scale
Standard Deviation 34.91
|
—
|
|
Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
10 min
|
69.8 Units on a scale
Standard Deviation 31.47
|
67.3 Units on a scale
Standard Deviation 35.16
|
64.6 Units on a scale
Standard Deviation 37.72
|
—
|
|
Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
20min
|
73.4 Units on a scale
Standard Deviation 32.39
|
64.7 Units on a scale
Standard Deviation 34.15
|
61.4 Units on a scale
Standard Deviation 38.49
|
—
|
SECONDARY outcome
Timeframe: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.Population: All participants who had tasted study interventions (in different vehicles) and made scores on the taste questionnaires were included in this analysis.
Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=12 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
1 min
|
42.5 Units on a scale
Standard Deviation 28.18
|
38.7 Units on a scale
Standard Deviation 30.57
|
31.2 Units on a scale
Standard Deviation 28.69
|
—
|
|
Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
5 min
|
45.5 Units on a scale
Standard Deviation 34.74
|
35.3 Units on a scale
Standard Deviation 30.52
|
35.0 Units on a scale
Standard Deviation 31.38
|
—
|
|
Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
10 min
|
43.7 Units on a scale
Standard Deviation 33.07
|
32.4 Units on a scale
Standard Deviation 30.46
|
37.6 Units on a scale
Standard Deviation 36.98
|
—
|
|
Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
20min
|
42.6 Units on a scale
Standard Deviation 35.50
|
33.8 Units on a scale
Standard Deviation 30.76
|
36.6 Units on a scale
Standard Deviation 31.50
|
—
|
SECONDARY outcome
Timeframe: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.Population: All participants who had tasted study interventions (in different vehicles) and made scores on the taste questionnaires were included in this analysis.
Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=12 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
1 min
|
37.4 Units on a scale
Standard Deviation 29.85
|
34.6 Units on a scale
Standard Deviation 32.15
|
27.6 Units on a scale
Standard Deviation 24.17
|
—
|
|
Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
5 min
|
42.6 Units on a scale
Standard Deviation 32.04
|
29.7 Units on a scale
Standard Deviation 29.61
|
34.9 Units on a scale
Standard Deviation 31.35
|
—
|
|
Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
10 min
|
40.7 Units on a scale
Standard Deviation 31.09
|
30.7 Units on a scale
Standard Deviation 29.63
|
39.5 Units on a scale
Standard Deviation 38.53
|
—
|
|
Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
20min
|
40.5 Units on a scale
Standard Deviation 33.32
|
32.5 Units on a scale
Standard Deviation 29.41
|
40.3 Units on a scale
Standard Deviation 35.70
|
—
|
SECONDARY outcome
Timeframe: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.Population: All participants who had tasted study interventions (in different vehicles) and made scores on the taste questionnaires were included in this analysis.
Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=12 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=11 Participants
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
20min
|
75.2 Units on a scale
Standard Deviation 32.14
|
65.0 Units on a scale
Standard Deviation 35.98
|
63.9 Units on a scale
Standard Deviation 40.19
|
—
|
|
Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
1 min
|
77.9 Units on a scale
Standard Deviation 28.53
|
62.5 Units on a scale
Standard Deviation 33.89
|
61.8 Units on a scale
Standard Deviation 34.69
|
—
|
|
Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
5 min
|
78.2 Units on a scale
Standard Deviation 30.28
|
67.0 Units on a scale
Standard Deviation 34.27
|
66.5 Units on a scale
Standard Deviation 38.34
|
—
|
|
Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
10 min
|
77.9 Units on a scale
Standard Deviation 30.83
|
67.5 Units on a scale
Standard Deviation 37.16
|
64.6 Units on a scale
Standard Deviation 38.99
|
—
|
Adverse Events
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets
n=11 participants at risk
Nirmatrelvir/ritonavir 300/100 mg commercial tablets were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water
n=11 participants at risk
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce
n=12 participants at risk
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce were administered under fasted conditions.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding
n=11 participants at risk
Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding were administered under fasted conditions.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/12 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
|
Gastrointestinal disorders
Gastritis
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/12 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
8.3%
1/12 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
18.2%
2/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
8.3%
1/12 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/12 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/12 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
|
General disorders
Vessel puncture site bruise
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/12 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/12 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
|
Injury, poisoning and procedural complications
Incision site complication
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/12 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/12 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/12 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/12 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/12 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/12 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
0.00%
0/12 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
9.1%
1/11 • Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place