Trial Outcomes & Findings for Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition (NCT NCT04916769)
NCT ID: NCT04916769
Last Updated: 2024-11-07
Results Overview
AUCinf was calculated as \[AUClast+(Clast\*/kel)\], where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the Clast, Clast is the last quantifiable concentration, Clast\* is the predicted plasma concentration at the last quantifiable time point estimated 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. The geometric coefficient of variation was reported as percentage.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose
Results posted on
2024-11-07
Participant Flow
A total of 18 participants were assigned to the study intervention, 16 of whom received all the 3 randomized treatment by sequence and completed the study.
Participant milestones
| Measure |
Sequence 1: Treatment C=>Treatment A =>Treatment B
Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses.
|
Sequence 2: Treatment B=>Treatment C =>Treatment A
Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses.
|
Sequence 3: Treatment A=>Treatment B =>Treatment C
Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses.
|
Sequence 4: Treatment B=>Treatment A =>Treatment C
Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses.
|
Sequence 5: Treatment A=>Treatment C =>Treatment B
Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses.
|
Sequence 6: Treatment C=>Treatment B =>Treatment A
Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Period 1
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
2
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 2
STARTED
|
3
|
3
|
3
|
3
|
3
|
2
|
|
Period 2
COMPLETED
|
3
|
2
|
3
|
3
|
3
|
2
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
3
|
2
|
3
|
3
|
3
|
2
|
|
Period 3
COMPLETED
|
3
|
2
|
3
|
3
|
3
|
2
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: Treatment C=>Treatment A =>Treatment B
Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses.
|
Sequence 2: Treatment B=>Treatment C =>Treatment A
Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses.
|
Sequence 3: Treatment A=>Treatment B =>Treatment C
Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses.
|
Sequence 4: Treatment B=>Treatment A =>Treatment C
Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses.
|
Sequence 5: Treatment A=>Treatment C =>Treatment B
Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses.
|
Sequence 6: Treatment C=>Treatment B =>Treatment A
Treatment A: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce. Treatment B: Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt. Treatment C: Bosutinib 500 mg single dose was administered as intact capsules. There were at least 14 days between successive bosutinib doses.
|
|---|---|---|---|---|---|---|
|
Period 1
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 2
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=18 Participants
Includes all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|---|---|
|
Age, Continuous
|
32.0 years
n=5 Participants
|
|
Age, Customized
18-25 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
26-35 years
|
8 Participants
n=5 Participants
|
|
Age, Customized
36-45 years
|
5 Participants
n=5 Participants
|
|
Age, Customized
Older than 45 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dosePopulation: Total number of participants received treatment and had bosutinib pharmacokinetic (PK) parameter contributing to the summary statistics.
AUCinf was calculated as \[AUClast+(Clast\*/kel)\], where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the Clast, Clast is the last quantifiable concentration, Clast\* is the predicted plasma concentration at the last quantifiable time point estimated 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. The geometric coefficient of variation was reported as percentage.
Outcome measures
| Measure |
Bosutinib 500 mg Capsule Contents + Applesauce 45 mL
n=16 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce.
|
Bosutinib 500 mg Capsule Contents + Yogurt 45 mL
n=17 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt.
|
Bosutinib 500 mg Intact Capsule
n=17 Participants
Bosutinib 500 mg single dose was administered as intact capsules.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Bosutinib
|
3312 nanogram•hour per milliliter (ng•hr/mL)
Geometric Coefficient of Variation 28
|
3205 nanogram•hour per milliliter (ng•hr/mL)
Geometric Coefficient of Variation 23
|
3161 nanogram•hour per milliliter (ng•hr/mL)
Geometric Coefficient of Variation 32
|
PRIMARY outcome
Timeframe: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dosePopulation: Total number of participants received treatment and had bosutinib PK parameter contributing to the summary statistics.
Cmax was the maximum observed plasma concentration. The geometric coefficient of variation was reported as percentage.
Outcome measures
| Measure |
Bosutinib 500 mg Capsule Contents + Applesauce 45 mL
n=16 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce.
|
Bosutinib 500 mg Capsule Contents + Yogurt 45 mL
n=17 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt.
|
Bosutinib 500 mg Intact Capsule
n=17 Participants
Bosutinib 500 mg single dose was administered as intact capsules.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for Bosutinib
|
126.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
126.1 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
132.0 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
SECONDARY outcome
Timeframe: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dosePopulation: Total number of participants received treatment and had bosutinib PK parameter contributing to the summary statistics.
AUClast was the area under the concentration-time curve from time 0 to the time of the last quantifiable concentration. Linear/Log trapezoidal method was used to determine AUClast. The geometric coefficient of variation was reported as percentage.
Outcome measures
| Measure |
Bosutinib 500 mg Capsule Contents + Applesauce 45 mL
n=16 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce.
|
Bosutinib 500 mg Capsule Contents + Yogurt 45 mL
n=17 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt.
|
Bosutinib 500 mg Intact Capsule
n=17 Participants
Bosutinib 500 mg single dose was administered as intact capsules.
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Bosutinib
|
3150 nanogram•hour per milliliter (ng•hr/mL)
Geometric Coefficient of Variation 28
|
3055 nanogram•hour per milliliter (ng•hr/mL)
Geometric Coefficient of Variation 23
|
3009 nanogram•hour per milliliter (ng•hr/mL)
Geometric Coefficient of Variation 33
|
SECONDARY outcome
Timeframe: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dosePopulation: Total number of participants received treatment and had bosutinib PK parameter contributing to the summary statistics.
Tmax was the time to reach maximum observed plasma concentration and was observed directly from data as time of the first occurrence.
Outcome measures
| Measure |
Bosutinib 500 mg Capsule Contents + Applesauce 45 mL
n=16 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce.
|
Bosutinib 500 mg Capsule Contents + Yogurt 45 mL
n=17 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt.
|
Bosutinib 500 mg Intact Capsule
n=17 Participants
Bosutinib 500 mg single dose was administered as intact capsules.
|
|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Bosutinib
|
6.00 hour
Interval 2.0 to 8.02
|
6.00 hour
Interval 2.0 to 8.0
|
6.00 hour
Interval 3.0 to 12.0
|
SECONDARY outcome
Timeframe: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dosePopulation: Total number of participants received treatment and had bosutinib PK parameter contributing to the summary statistics.
CL/F was the apparent clearance after oral dose and was determined as dose/AUCinf. The geometric coefficient of variation was reported as percentage.
Outcome measures
| Measure |
Bosutinib 500 mg Capsule Contents + Applesauce 45 mL
n=16 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce.
|
Bosutinib 500 mg Capsule Contents + Yogurt 45 mL
n=17 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt.
|
Bosutinib 500 mg Intact Capsule
n=17 Participants
Bosutinib 500 mg single dose was administered as intact capsules.
|
|---|---|---|---|
|
Apparent Clearance After Oral Dose (CL/F) for Bosutinib
|
151.0 liter/hour
Geometric Coefficient of Variation 28
|
156.0 liter/hour
Geometric Coefficient of Variation 23
|
158.1 liter/hour
Geometric Coefficient of Variation 32
|
SECONDARY outcome
Timeframe: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dosePopulation: Total number of participants received treatment and had bosutinib PK parameter contributing to the summary statistics.
Vz/F was the apparent volume of distribution after oral dose. It was determined as dose/(AUCinf × kel), where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration time curve. The geometric coefficient of variation was reported as percentage.
Outcome measures
| Measure |
Bosutinib 500 mg Capsule Contents + Applesauce 45 mL
n=16 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce.
|
Bosutinib 500 mg Capsule Contents + Yogurt 45 mL
n=17 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt.
|
Bosutinib 500 mg Intact Capsule
n=17 Participants
Bosutinib 500 mg single dose was administered as intact capsules.
|
|---|---|---|---|
|
Apparent Volume of Distribution After Oral Dose (Vz/F) for Bosutinib
|
7903 liter
Geometric Coefficient of Variation 31
|
8106 liter
Geometric Coefficient of Variation 28
|
8145 liter
Geometric Coefficient of Variation 41
|
SECONDARY outcome
Timeframe: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dosePopulation: Total number of participants received treatment and had bosutinib PK parameter contributing to the summary statistics.
t½ was the terminal elimination plasma half-life. It was determined as Loge(2)/kel, where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Bosutinib 500 mg Capsule Contents + Applesauce 45 mL
n=16 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce.
|
Bosutinib 500 mg Capsule Contents + Yogurt 45 mL
n=17 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt.
|
Bosutinib 500 mg Intact Capsule
n=17 Participants
Bosutinib 500 mg single dose was administered as intact capsules.
|
|---|---|---|---|
|
Terminal Phase Half-life (t½ ) for Bosutinib
|
36.46 hour
Standard Deviation 3.7067
|
36.30 hour
Standard Deviation 4.6893
|
36.02 hour
Standard Deviation 4.9889
|
SECONDARY outcome
Timeframe: Post first dose and up to Day 7 in Period 3, or at early termination/discontinuation.Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Laboratory tests included hematology tests, chemistry tests, and urinalysis tests.
Outcome measures
| Measure |
Bosutinib 500 mg Capsule Contents + Applesauce 45 mL
n=16 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce.
|
Bosutinib 500 mg Capsule Contents + Yogurt 45 mL
n=17 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt.
|
Bosutinib 500 mg Intact Capsule
n=18 Participants
Bosutinib 500 mg single dose was administered as intact capsules.
|
|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities
|
8 Participants
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
TEAEs are those with initial onset or that worsen in severity after the first dose of the study medication. All AEs in the table below were TEAEs. An SAE is any untoward medical occurrence at any dose that: results in death; is life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event. Severe AEs were defined as AEs that interfered significantly with participant's usual function. Both SAEs and severe AEs were according to the investigator's assessment.
Outcome measures
| Measure |
Bosutinib 500 mg Capsule Contents + Applesauce 45 mL
n=16 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce.
|
Bosutinib 500 mg Capsule Contents + Yogurt 45 mL
n=17 Participants
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt.
|
Bosutinib 500 mg Intact Capsule
n=18 Participants
Bosutinib 500 mg single dose was administered as intact capsules.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Severe Adverse Events (AEs), and Serious Adverse Events (SAEs)
Participants with SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Severe Adverse Events (AEs), and Serious Adverse Events (SAEs)
Participants with TEAEs
|
11 Participants
|
14 Participants
|
15 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Severe Adverse Events (AEs), and Serious Adverse Events (SAEs)
Participants with severe AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Bosutinib 500 mg Capsule Contents + Applesauce 45 mL
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Bosutinib 500 mg Capsule Contents + Yogurt 45 mL
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Bosutinib 500 mg Intact Capsule
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bosutinib 500 mg Capsule Contents + Applesauce 45 mL
n=16 participants at risk
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL applesauce.
|
Bosutinib 500 mg Capsule Contents + Yogurt 45 mL
n=17 participants at risk
Bosutinib 500 mg single dose was administered as capsule contents mixed with 45 mL yogurt.
|
Bosutinib 500 mg Intact Capsule
n=18 participants at risk
Bosutinib 500 mg single dose was administered as intact capsules.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
18.8%
3/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
17.6%
3/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
16.7%
3/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.6%
1/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
2/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
11.8%
2/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
16.7%
3/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.9%
1/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
43.8%
7/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
64.7%
11/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
55.6%
10/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.6%
1/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.9%
1/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
11.1%
2/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.9%
1/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.6%
1/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
35.3%
6/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
22.2%
4/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.9%
1/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.6%
1/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
General disorders
Chills
|
6.2%
1/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
11.8%
2/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
General disorders
Fatigue
|
18.8%
3/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
17.6%
3/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
11.1%
2/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.6%
1/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
11.8%
2/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
General disorders
Vessel puncture site reaction
|
6.2%
1/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.9%
1/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Infections and infestations
Ear infection
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.6%
1/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Infections and infestations
Tooth abscess
|
6.2%
1/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.6%
1/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Investigations
Hepatic enzyme increased
|
6.2%
1/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
11.1%
2/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.9%
1/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.6%
1/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.6%
1/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.6%
1/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.9%
1/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.6%
1/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.9%
1/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
1/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract irritation
|
6.2%
1/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.6%
1/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.9%
1/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/16 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
0.00%
0/17 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
5.6%
1/18 • Up to 12 weeks
The analysis of adverse events included all participants who received at least 1 dose of the randomized study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER