Trial Outcomes & Findings for Relative Bioavailability Study of Nirmatrelvir/Ritonavir Oral Powder Relative to the Commercial Tablets and Estimation of the Effect of Food on Bioavailability of the Nirmatrelvir/Ritonavir Oral Powder in Healthy Participants. (NCT NCT05544786)
NCT ID: NCT05544786
Last Updated: 2024-05-10
Results Overview
AUCinf was defined as area under the concentration-time curve from time 0 extrapolated to infinity. 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; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 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 after dose on Day 1 of Periods 1, 2, 3, 4, and 5.
Results posted on
2024-05-10
Participant Flow
A total of 12 participants were assigned to the study.
Participant milestones
| Measure |
Treatment A->B->C->D->E
Each enrolled participant participated in 5 study periods (1-5) to receive 5 different treatments (A, B, C, D, E) according to the sequence determined by randomization. Between each treatment, a minimum of 4 days washout was proposed to minimize any residual nirmatrelvir concentrations prior to start of the next treatment.
Period 1: Treatment A: Single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted condition.
Period 2: Treatment B: Single oral dose of nirmatrelvir 300 and ritonavir 100 mg oral powder mixed in water under fasted condition.
Period 3: Treatment C: Single oral dose of nirmatrelvir 300 and ritonavir 100 mg oral powder mixed in infant formula under fasted condition.
Period 4: Treatment D: Single oral dose of nirmatrelvir 300 and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition.
Period 5: Treatment E: Single oral dose of nirmatrelvir 300 and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition.
|
Treatment B->C->A->D->E
Each enrolled participant participated in 5 study periods (1-5) to receive 5 different treatments (A, B, C, D, E) according to the sequence determined by randomization. Between each treatment, a minimum of 4 days washout was proposed to minimize any residual nirmatrelvir concentrations prior to start of the next treatment.
Period 1: Treatment B: Single oral dose of nirmatrelvir 300 and ritonavir 100 mg oral powder mixed in water under fasted condition.
Period 2: Treatment C: Single oral dose of nirmatrelvir 300 and ritonavir 100 mg oral powder mixed in infant formula under fasted condition.
Period 3: Treatment A: Single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted condition.
Period 4: Treatment D: Single oral dose of nirmatrelvir 300 and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition.
Period 5: Treatment E: Single oral dose of nirmatrelvir 300 and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition.
|
Treatment C->A->B->D->E
Each enrolled participant participated in 5 study periods (1-5) to receive 5 different treatments (A, B, C, D, E) according to the sequence determined by randomization. Between each treatment, a minimum of 4 days washout was proposed to minimize any residual nirmatrelvir concentrations prior to start of the next treatment.
Period 1: Treatment C: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition.
Period 2: Treatment A: Single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted condition.
Period 3: Treatment B: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition.
Period 4: Treatment D: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition.
Period 5: Treatment E: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition.
|
Treatment A->C->B->E->D
Each enrolled participant participated in 5 study periods (1-5) to receive 5 different treatments (A, B, C, D, E) according to the sequence determined by randomization. Between each treatment, a minimum of 4 days washout was proposed to minimize any residual nirmatrelvir concentrations prior to start of the next treatment.
Period 1: Treatment A: Single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted condition.
Period 2: Treatment C: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition.
Period 3: Treatment B: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition.
Period 4: Treatment E: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition.
Period 5: Treatment D: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition.
|
Treatment B->A->C->E->D
Each enrolled participant participated in 5 study periods (1-5) to receive 5 different treatments (A, B, C, D, E) according to the sequence determined by randomization. Between each treatment, a minimum of 4 days washout was proposed to minimize any residual nirmatrelvir concentrations prior to start of the next treatment.
Period 1: Treatment B: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition.
Period 2: Treatment A: Single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted condition.
Period 3: Treatment C: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition.
Period 4: Treatment E: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition.
Period 5: Treatment D: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition.
|
Treatment C->B->A->E->D
Each enrolled participant participated in 5 study periods (1-5) to receive 5 different treatments (A, B, C, D, E) according to the sequence determined by randomization. Between each treatment, a minimum of 4 days washout was proposed to minimize any residual nirmatrelvir concentrations prior to start of the next treatment.
Period 1: Treatment C: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition.
Period 2: Treatment B: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition.
Period 3: Treatment A: Single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted condition.
Period 4: Treatment E: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition.
Period 5: Treatment D: Single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition.
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|---|---|---|---|---|---|---|
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Overall Study
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Relative Bioavailability Study of Nirmatrelvir/Ritonavir Oral Powder Relative to the Commercial Tablets and Estimation of the Effect of Food on Bioavailability of the Nirmatrelvir/Ritonavir Oral Powder in Healthy Participants.
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participants
All participants who were enrolled in this study.
|
|---|---|
|
Age, Continuous
Mean (SD)
|
47.2 Years
STANDARD_DEVIATION 8.88 • n=5 Participants
|
|
Age, Customized
18-44 Years
|
4 Participants
n=5 Participants
|
|
Age, Customized
45-64 Years
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 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 after dose on Day 1 of Periods 1, 2, 3, 4, and 5.Population: 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 was defined as area under the concentration-time curve from time 0 extrapolated to infinity. 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; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
|
27090 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 18
|
30650 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 22
|
33030 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 24
|
34000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 22
|
32810 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 18
|
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 after dose on Day 1 of Periods 1, 2, 3, 4, and 5.Population: 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 was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for nirmatrelvir was calculated by linear/log trapezoidal method.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
|
26500 ng*hr/mL
Geometric Coefficient of Variation 20
|
30110 ng*hr/mL
Geometric Coefficient of Variation 23
|
32470 ng*hr/mL
Geometric Coefficient of Variation 25
|
33540 ng*hr/mL
Geometric Coefficient of Variation 22
|
32410 ng*hr/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 after dose on Day 1 of Periods 1, 2, 3, 4, and 5.Population: 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 was defined maximum observed concentration. Cmax for nirmatrelvir was observed directly from data.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
|
2862 ng/mL
Geometric Coefficient of Variation 20
|
3156 ng/mL
Geometric Coefficient of Variation 26
|
4034 ng/mL
Geometric Coefficient of Variation 23
|
4287 ng/mL
Geometric Coefficient of Variation 22
|
4208 ng/mL
Geometric Coefficient of Variation 23
|
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 after dose on Day 1 of Periods 1, 2, 3, 4, and 5.Population: 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 was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for ritonavir 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; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
n=11 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
|
4005 ng*hr/mL
Geometric Coefficient of Variation 37
|
3876 ng*hr/mL
Geometric Coefficient of Variation 34
|
3479 ng*hr/mL
Geometric Coefficient of Variation 40
|
3986 ng*hr/mL
Geometric Coefficient of Variation 34
|
3176 ng*hr/mL
Geometric Coefficient of Variation 30
|
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 after dose on Day 1 of Periods 1, 2, 3, 4, and 5.Population: 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 was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for ritonavir was calculated by linear/log trapezoidal method.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
|
3818 ng*hr/mL
Geometric Coefficient of Variation 38
|
3663 ng*hr/mL
Geometric Coefficient of Variation 35
|
3303 ng*hr/mL
Geometric Coefficient of Variation 40
|
3371 ng*hr/mL
Geometric Coefficient of Variation 49
|
2959 ng*hr/mL
Geometric Coefficient of Variation 32
|
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 after dose on Day 1 of Periods 1, 2, 3, 4, and 5.Population: 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 was defined maximum observed concentration. Cmax for ritonavir was observed directly from data.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
|
398.4 ng/mL
Geometric Coefficient of Variation 47
|
406.1 ng/mL
Geometric Coefficient of Variation 46
|
368.1 ng/mL
Geometric Coefficient of Variation 52
|
386.6 ng/mL
Geometric Coefficient of Variation 66
|
280.7 ng/mL
Geometric Coefficient of Variation 35
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5.Population: 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 was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for nirmatrelvir (under fasted/fed conditions) 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; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
|
34000 ng*hr/mL
Geometric Coefficient of Variation 22
|
32810 ng*hr/mL
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5.Population: 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 was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for nirmatrelvir (under fasted/fed conditions) was calculated by linear/log trapezoidal method.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
|
33540 ng*hr/mL
Geometric Coefficient of Variation 22
|
32410 ng*hr/mL
Geometric Coefficient of Variation 19
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5.Population: 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 was defined maximum observed concentration. Cmax for nirmatrelvir (under fasted/fed conditions) was observed directly from data.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
|
4287 ng/mL
Geometric Coefficient of Variation 22
|
4208 ng/mL
Geometric Coefficient of Variation 23
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5.Population: 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 was defined as area under the concentration-time curve from time 0 extrapolated to infinity. AUCinf for ritonavir (under fasted/fed conditions) 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; AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=11 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
|
3986 ng*hr/mL
Geometric Coefficient of Variation 34
|
3176 ng*hr/mL
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5.Population: 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 was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for ritonavir (under fasted/fed conditions) was calculated by linear/log trapezoidal method.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
|
3371 ng*hr/mL
Geometric Coefficient of Variation 49
|
2959 ng*hr/mL
Geometric Coefficient of Variation 32
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours after dose on Day 1 of Periods 4 and 5.Population: 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 was defined maximum observed concentration. Cmax for ritonavir (under fasted/fed conditions) was observed directly from data.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir Mixed With Vanilla Pudding Under Fasted/Fed Conditions
|
386.6 ng/mL
Geometric Coefficient of Variation 66
|
280.7 ng/mL
Geometric Coefficient of Variation 35
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).Population: All participants who took at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study intervention and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. TEAEs included SAEs and all non-SAEs that occurred during the study.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs)
Participants with all-causality TEAEs
|
2 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs)
Participants with all-causality SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs)
Participants with treatment-related TEAEs
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With All-Causality and Treatment-Related Treatment-emergent Adverse Events (TEAEs)
Participants with treatment-related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 4 of Period 5 (approximately 20 days)Population: All participants who took at least 1 dose of study intervention and with at least 1 observation of the given laboratory test while on study treatment or during lag time.
The following laboratory test abnormalities (without regard to baseline abnormality) were reported during the study: monocytes/leukocytes (percentage \[%\]) is larger than (\>) 1.2x upper limit of normal (ULN), specific gravity (scalar) \>1.030, and urine hemoglobin was larger or equal to (\>=) 1.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Monocytes/Leukocytes (%) >1.2x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Specific gravity (scalar) >1.030
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Urine hemoglobin >=1
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 4 of Period 5 (approximately 20 days).Population: All participants who took at least 1 dose of study intervention.
Supine blood pressure and pulse rate were measured with the participant's arm supported at the level of the heart and recorded after approximately 5 minutes of rest. Vital signs were done predose, 2 hours and 6 hours post dose on Day 1 of each treatment period and also on Day 4 of Period 5. Clinical significance of vital signs was determined at the investigator's discretion.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 4 of Period 5 (approximately 20 days).Population: All participants who took at least 1 dose of study intervention.
A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QT, and QTc intervals and QRS complex. All scheduled ECGs were performed after the participant has rested quietly for at least 5 minutes in a supine position. Clinical significance of ECG values was determined at the investigator's discretion.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening, Baseline up to Day 4 of Period 5 (approximately 20 days).Population: All participants who took at least 1 dose of study intervention.
A complete physical examination 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. Completed PE were performed by trained medical personnel at the investigator site at Screening or Period 1 Day 1 only. A brief PE might be performed at other designated time points at the discretion of the investigator. Clinical significance of physical examination values was determined at the investigator's discretion.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Physical Examination (PE) Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period.Population: All participants who took at least 1 dose of study intervention.
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
1 minute
|
66.8 Units on a scale
Interval 54.08 to 79.42
|
65.4 Units on a scale
Interval 55.79 to 75.05
|
56.3 Units on a scale
Interval 46.17 to 66.5
|
—
|
—
|
|
Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
5 minutes
|
73.8 Units on a scale
Interval 62.36 to 85.14
|
60.3 Units on a scale
Interval 51.86 to 68.64
|
57.2 Units on a scale
Interval 48.16 to 66.17
|
—
|
—
|
|
Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
10 minutes
|
72.4 Units on a scale
Interval 61.34 to 83.49
|
59.3 Units on a scale
Interval 52.22 to 66.28
|
56.7 Units on a scale
Interval 46.44 to 66.89
|
—
|
—
|
|
Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
20 minutes
|
65.5 Units on a scale
Interval 55.87 to 75.13
|
56.3 Units on a scale
Interval 46.43 to 66.24
|
53.4 Units on a scale
Interval 43.3 to 63.54
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period.Population: All participants who took at least 1 dose of study intervention.
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
1 minute
|
75.3 Units on a scale
Interval 62.27 to 88.23
|
72.0 Units on a scale
Interval 63.22 to 80.78
|
61.4 Units on a scale
Interval 51.35 to 71.49
|
—
|
—
|
|
Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
5 minutes
|
75.4 Units on a scale
Interval 65.0 to 85.83
|
66.5 Units on a scale
Interval 59.09 to 73.91
|
58.2 Units on a scale
Interval 50.21 to 66.12
|
—
|
—
|
|
Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
10 minutes
|
72.1 Units on a scale
Interval 62.72 to 81.44
|
56.8 Units on a scale
Interval 47.15 to 66.35
|
56.8 Units on a scale
Interval 46.59 to 67.08
|
—
|
—
|
|
Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
20 minutes
|
66.2 Units on a scale
Interval 56.47 to 75.86
|
57.0 Units on a scale
Interval 48.14 to 65.86
|
55.4 Units on a scale
Interval 43.97 to 66.86
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period.Population: All participants who took at least 1 dose of study intervention.
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
1 minute
|
31.3 Units on a scale
Interval 17.5 to 45.0
|
36.3 Units on a scale
Interval 20.15 to 52.52
|
32.4 Units on a scale
Interval 16.58 to 48.25
|
—
|
—
|
|
Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
5 minutes
|
33.9 Units on a scale
Interval 18.74 to 49.09
|
29.9 Units on a scale
Interval 16.51 to 43.32
|
29.8 Units on a scale
Interval 14.73 to 44.93
|
—
|
—
|
|
Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
10 minutes
|
36.3 Units on a scale
Interval 19.61 to 52.89
|
29.7 Units on a scale
Interval 17.17 to 42.17
|
29.7 Units on a scale
Interval 15.83 to 43.5
|
—
|
—
|
|
Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
20 minutes
|
31.0 Units on a scale
Interval 17.22 to 44.78
|
25.8 Units on a scale
Interval 12.18 to 39.49
|
26.7 Units on a scale
Interval 13.46 to 39.87
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period.Population: All participants who took at least 1 dose of study intervention.
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
1 minute
|
30.9 Units on a scale
Interval 17.52 to 44.31
|
31.7 Units on a scale
Interval 15.42 to 47.92
|
26.4 Units on a scale
Interval 12.35 to 40.48
|
—
|
—
|
|
Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
5 minutes
|
34.5 Units on a scale
Interval 18.32 to 50.68
|
37.5 Units on a scale
Interval 21.44 to 53.56
|
27.3 Units on a scale
Interval 12.56 to 41.94
|
—
|
—
|
|
Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
10 minutes
|
34.4 Units on a scale
Interval 18.62 to 50.21
|
34.8 Units on a scale
Interval 17.9 to 51.6
|
29.4 Units on a scale
Interval 15.89 to 42.95
|
—
|
—
|
|
Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
20 minutes
|
33.7 Units on a scale
Interval 18.9 to 48.43
|
31.3 Units on a scale
Interval 16.1 to 46.4
|
27.8 Units on a scale
Interval 13.96 to 41.54
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 5, 10 and 20 minutes after tasting each study intervention on Day 1 of each period.Population: All participants who took at least 1 dose of study intervention.
The sensory attributes of nirmatrelvir/ritonavir oral powder were evaluated by the participant using a Palatability Questionnaire. Each participant complete the palatability survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of nirmatrelvir/ritonavir oral powder. For the taste assessment of the study, the data used in the analysis were transcribed and rescaled to a score from 0 (good) to 100 (bad) from the raw measurements on the questionnaire.
Outcome measures
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 Participants
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
1 minute
|
73.5 Units on a scale
Interval 62.24 to 84.76
|
65.0 Units on a scale
Interval 53.6 to 76.4
|
55.8 Units on a scale
Interval 45.43 to 66.24
|
—
|
—
|
|
Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
5 minutes
|
74.7 Units on a scale
Interval 64.19 to 85.15
|
66.3 Units on a scale
Interval 54.81 to 77.69
|
55.9 Units on a scale
Interval 46.29 to 65.54
|
—
|
—
|
|
Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
10 minutes
|
72.6 Units on a scale
Interval 63.09 to 82.08
|
62.4 Units on a scale
Interval 53.45 to 71.39
|
57.1 Units on a scale
Interval 47.06 to 67.11
|
—
|
—
|
|
Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
20 minutes
|
64.7 Units on a scale
Interval 51.68 to 77.66
|
56.4 Units on a scale
Interval 42.48 to 70.35
|
56.3 Units on a scale
Interval 46.25 to 66.42
|
—
|
—
|
Adverse Events
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nirmatrelvir/Ritonavir 300/100 mg Tablets (Fasted)
n=12 participants at risk
Participants received a single oral dose of nirmatrelvir 300 (2\*150) mg and ritonavir 100 mg tablets under fasted conditions on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water (Fasted)
n=12 participants at risk
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in water under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Infant Formula (Fasted)
n=12 participants at risk
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in infant formula under fasted condition on Day 1 of Periods 1, 2, and 3.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fasted)
n=12 participants at risk
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fasted condition on Day 1 of Periods 4 and 5.
|
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding (Fed)
n=12 participants at risk
Participants received a single oral dose of nirmatrelvir 300 mg and ritonavir 100 mg oral powder mixed in vanilla pudding under fed condition on Day 1 of Periods 4 and 5.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
|
Gastrointestinal disorders
Oral disorder
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
|
General disorders
Fatigue
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
16.7%
2/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
|
Vascular disorders
Haematoma
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
8.3%
1/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
0.00%
0/12 • Baseline up to 28 days after last dose of study intervention (ie, up to 48 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place