Trial Outcomes & Findings for Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Orally Administered Bosutinib Capsule (NCT NCT05032690)
NCT ID: NCT05032690
Last Updated: 2024-09-20
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
32 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
2024-09-20
Participant Flow
A total of 32 participants were assigned to the study intervention, of whom 26 participants received all the randomized treatment by sequence and 25 participants completed the study.
Participant milestones
| Measure |
Treatment A -> Treatment B -> Treatment C
Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition. Treatment C: 1 × 100 mg bosutinib capsule under fasted condition. The participant took Treatment A in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment B in Period 2, followed with another at least 14-days washout between successive bosutinib doses, and then Treatment C in Period 3.
|
Treatment B -> Treatment A -> Treatment C
Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition. Treatment C: 1 × 100 mg bosutinib capsule under fasted condition. The participant took Treatment B in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment A in Period 2, followed with another at least 14-days washout between successive bosutinib doses, and then Treatment C in Period 3.
|
Treatment A ->Treatment B
Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition.The participant took Treatment A in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment B in Period 2.
|
Treatment B->Treatment A
Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition. The participant took Treatment B in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment A in Period 2.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
8
|
10
|
7
|
7
|
|
Period 1
COMPLETED
|
7
|
8
|
7
|
7
|
|
Period 1
NOT COMPLETED
|
1
|
2
|
0
|
0
|
|
Period 2
STARTED
|
7
|
8
|
7
|
7
|
|
Period 2
COMPLETED
|
6
|
6
|
7
|
7
|
|
Period 2
NOT COMPLETED
|
1
|
2
|
0
|
0
|
|
Period 3
STARTED
|
6
|
6
|
0
|
0
|
|
Period 3
COMPLETED
|
6
|
5
|
0
|
0
|
|
Period 3
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment A -> Treatment B -> Treatment C
Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition. Treatment C: 1 × 100 mg bosutinib capsule under fasted condition. The participant took Treatment A in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment B in Period 2, followed with another at least 14-days washout between successive bosutinib doses, and then Treatment C in Period 3.
|
Treatment B -> Treatment A -> Treatment C
Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition. Treatment C: 1 × 100 mg bosutinib capsule under fasted condition. The participant took Treatment B in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment A in Period 2, followed with another at least 14-days washout between successive bosutinib doses, and then Treatment C in Period 3.
|
Treatment A ->Treatment B
Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition.The participant took Treatment A in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment B in Period 2.
|
Treatment B->Treatment A
Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition. The participant took Treatment B in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment A in Period 2.
|
|---|---|---|---|---|
|
Period 1
Adverse Event
|
0
|
1
|
0
|
0
|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Period 1
No longer meets eligibility criteria
|
0
|
1
|
0
|
0
|
|
Period 2
Adverse Event
|
1
|
0
|
0
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Period 2
No longer meets eligibility criteria
|
0
|
1
|
0
|
0
|
|
Period 3
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Orally Administered Bosutinib Capsule
Baseline characteristics by cohort
| Measure |
Treatment A -> Treatment B -> Treatment C
n=8 Participants
Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition. Treatment C: 1 × 100 mg bosutinib capsule under fasted condition. The participant took Treatment A in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment B in Period 2, followed with another at least 14-days washout between successive bosutinib doses, and then Treatment C in Period 3.
|
Treatment B -> Treatment A -> Treatment C
n=10 Participants
Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition. Treatment C: 1 × 100 mg bosutinib capsule under fasted condition. The participant took Treatment B in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment A in Period 2, followed with another at least 14-days washout between successive bosutinib doses, and then Treatment C in Period 3.
|
Treatment A ->Treatment B
n=7 Participants
Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition.The participant took Treatment A in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment B in Period 2.
|
Treatment B->Treatment A
n=7 Participants
Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition. The participant took Treatment B in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment A in Period 2.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.5 years
n=5 Participants
|
38.0 years
n=7 Participants
|
42.0 years
n=5 Participants
|
42.0 years
n=4 Participants
|
39.5 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 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: The pharmacokinetic (PK) parameter analysis population is defined as all subjects randomized and treated who have at least 1 of the PK parameters of primary interest in at least 1 treatment period.
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 |
Treatment A: Bosutinib 1*100 mg Capsule Fed
n=21 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment B: Bosutinib 4*25 mg Capsule Fed
n=20 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants will then receive 4\*25 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment C: Bosutinib 1*100 mg Capsule Fasted
n=4 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours).
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Bosutinib
|
591.3 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 32
|
591.7 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 39
|
479.4 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 30
|
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: The PK parameter analysis population is defined as all subjects randomized and treated who have at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Cmax was the maximum observed plasma concentration. The geometric coefficient of variation was reported as percentage.
Outcome measures
| Measure |
Treatment A: Bosutinib 1*100 mg Capsule Fed
n=30 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment B: Bosutinib 4*25 mg Capsule Fed
n=31 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants will then receive 4\*25 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment C: Bosutinib 1*100 mg Capsule Fasted
n=12 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours).
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for Bosutinib
|
17.80 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40
|
16.68 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
10.75 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 58
|
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: The PK parameter analysis population is defined as all subjects randomized and treated who have at least 1 of the PK parameters of primary interest in at least 1 treatment period.
AUClast was the area under the concentration-time curve from time 0 to the time of the last quantifiable concentration.
Outcome measures
| Measure |
Treatment A: Bosutinib 1*100 mg Capsule Fed
n=30 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment B: Bosutinib 4*25 mg Capsule Fed
n=31 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants will then receive 4\*25 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment C: Bosutinib 1*100 mg Capsule Fasted
n=12 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours).
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Bosutinib
|
455.6 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 40
|
446.4 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 45
|
301.6 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 52
|
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: The PK parameter analysis population is defined as all subjects randomized and treated who have at least 1 of the PK parameters of primary interest in at least 1 treatment period.
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 |
Treatment A: Bosutinib 1*100 mg Capsule Fed
n=30 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment B: Bosutinib 4*25 mg Capsule Fed
n=31 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants will then receive 4\*25 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment C: Bosutinib 1*100 mg Capsule Fasted
n=12 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours).
|
|---|---|---|---|
|
Time for Cmax (Tmax) of Bosutinib
|
6.00 hour
Interval 4.0 to 12.0
|
6.00 hour
Interval 3.0 to 8.0
|
6.00 hour
Interval 3.0 to 8.02
|
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: The PK parameter analysis population is defined as all subjects randomized and treated who have at least 1 of the PK parameters of primary interest in at least 1 treatment period.
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 |
Treatment A: Bosutinib 1*100 mg Capsule Fed
n=21 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment B: Bosutinib 4*25 mg Capsule Fed
n=20 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants will then receive 4\*25 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment C: Bosutinib 1*100 mg Capsule Fasted
n=4 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours).
|
|---|---|---|---|
|
Apparent Clearance After Oral Dose (CL/F) of Bosutinib
|
169.3 liter/hour
Geometric Coefficient of Variation 32
|
169.0 liter/hour
Geometric Coefficient of Variation 39
|
208.5 liter/hour
Geometric Coefficient of Variation 30
|
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: The PK parameter analysis population is defined as all subjects randomized and treated who have at least 1 of the PK parameters of primary interest in at least 1 treatment period.
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 |
Treatment A: Bosutinib 1*100 mg Capsule Fed
n=21 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment B: Bosutinib 4*25 mg Capsule Fed
n=20 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants will then receive 4\*25 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment C: Bosutinib 1*100 mg Capsule Fasted
n=4 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours).
|
|---|---|---|---|
|
Apparent Volume of Distribution After Oral Dose (Vz/F) of Bosutinib
|
11130 liter
Geometric Coefficient of Variation 25
|
10650 liter
Geometric Coefficient of Variation 24
|
12870 liter
Geometric Coefficient of Variation 19
|
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: The PK parameter analysis population is defined as all subjects randomized and treated who have at least 1 of the PK parameters of primary interest in at least 1 treatment period.
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 |
Treatment A: Bosutinib 1*100 mg Capsule Fed
n=21 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment B: Bosutinib 4*25 mg Capsule Fed
n=20 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants will then receive 4\*25 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment C: Bosutinib 1*100 mg Capsule Fasted
n=4 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours).
|
|---|---|---|---|
|
Terminal Elimination Half-Life (t1/2) of Bosutinib
|
47.22 hour
Standard Deviation 11.753
|
46.01 hour
Standard Deviation 13.434
|
43.28 hour
Standard Deviation 7.6939
|
SECONDARY outcome
Timeframe: On Days 4, 5, 7 of Periods 1 and 2 for all participants, on Period 3 Days 4, 5, 7 for participants who were assigned to treatment sequences A=>B=>C and B=>A=>C, and at early termination/discontinuation (if applicable)Population: All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Laboratory tests included hematology tests, chemistry tests, and urinalysis tests. Laboratory parameters with at least 1 occurrence meeting the pre-defined criteria are reported for this outcome measure.
Outcome measures
| Measure |
Treatment A: Bosutinib 1*100 mg Capsule Fed
n=30 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment B: Bosutinib 4*25 mg Capsule Fed
n=31 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants will then receive 4\*25 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment C: Bosutinib 1*100 mg Capsule Fasted
n=12 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours).
|
|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Coronavirus 19 Molecular (Scalar) >0
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Specific Gravity (scalar) <1.003
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Specific Gravity (scalar) >1.030
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
URINE Hemoglobin ≥1
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Monocytes/Leukocytes (%) >1.2*upper normal limit (ULN)
|
7 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Aspartate Aminotransferase (U/L) > 3.0*ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Creatine Kinase (U/L) >2.0* ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Urobilinogen (EU/dL) ≥1
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
URINE Bilirubin ≥1
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)Population: 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 |
Treatment A: Bosutinib 1*100 mg Capsule Fed
n=30 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment B: Bosutinib 4*25 mg Capsule Fed
n=31 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants will then receive 4\*25 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment C: Bosutinib 1*100 mg Capsule Fasted
n=12 Participants
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours).
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Particiapnts with TEAEs
|
13 Participants
|
20 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants discontinued from study due to adverse events
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Particiapnts with SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Particiapnts with severe AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment B: Bosutinib 4*25 mg Capsule Fed
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Treatment C: Bosutinib 1*100 mg Capsule Fasted
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment A: Bosutinib 1*100 mg Capsule Fed
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment B: Bosutinib 4*25 mg Capsule Fed
n=31 participants at risk
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants will then receive 4\*25 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
Treatment C: Bosutinib 1*100 mg Capsule Fasted
n=12 participants at risk
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours).
|
Treatment A: Bosutinib 1*100 mg Capsule Fed
n=30 participants at risk
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Gastrointestinal disorders
Change of bowel habit
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.9%
4/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
8.3%
1/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
General disorders
Chills
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
General disorders
Fatigue
|
6.5%
2/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
8.3%
1/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
6.7%
2/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
General disorders
Feeling cold
|
0.00%
0/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
General disorders
Influenza like illness
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
General disorders
Pyrexia
|
6.5%
2/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
8.3%
1/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
General disorders
Vessel puncture site pain
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Infections and infestations
COVID-19
|
0.00%
0/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Infections and infestations
Viral infection
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.00%
0/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Investigations
SARS-CoV-2 test positive
|
6.5%
2/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
8.3%
1/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.7%
3/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Nervous system disorders
Headache
|
19.4%
6/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
13.3%
4/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Psychiatric disorders
Anxiety
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Renal and urinary disorders
Urine odour abnormal
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
2/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
3.3%
1/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
3.2%
1/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
|
Vascular disorders
Haematoma
|
6.5%
2/31 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
16.7%
2/12 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
0.00%
0/30 • Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place