Trial Outcomes & Findings for Drug-drug Interaction Between Belumosudil, Itraconazole, Rifampicin, Rabeprazole, and Omeprazole in Healthy Volunteers (NCT NCT03530995)
NCT ID: NCT03530995
Last Updated: 2022-05-25
Results Overview
Maximum concentration (Cmax) of the parent drug, KD025, Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2) for belumosudil alone, belumosudil + itraconazole, belumosudil + rabeprazole, and belumosudil + rifampicin at 0 to 48 hours post-dose
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
73 participants
Primary outcome timeframe
Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours post-dose
Results posted on
2022-05-25
Participant Flow
This was a single centre, non-randomised, open label, two-part study. Part 1 of the study was a 4-period sequential dose study in healthy male subjects. The estimated duration from screening to discharge from the study was approximately 10 weeks. Part 2 of the study was a 2-period sequential dose study in healthy males. The estimated duration from screening to discharge from the study was approximately 7 weeks.
Participant milestones
| Measure |
Part 1 Belumosudil (KD025) QD Dosing
Subjects received a single dose of belumosudil 200 mg on 4 separate occasions, and multiple single doses of itraconazole, rabeprazole and rifampicin, on separate occasions, for 9,4 and 9 consecutive days, respectively.
|
Part 2 Belumosudil (KD025) BID Dosing
Subjects received a twice daily dose of belumosudil 200 mg on 2 separate occasions, and single doses of omeprazole for 4 consecutive days.
|
|---|---|---|
|
Part 1 Period 1; Part 2 Period 1
STARTED
|
35
|
38
|
|
Part 1 Period 1; Part 2 Period 1
COMPLETED
|
35
|
38
|
|
Part 1 Period 1; Part 2 Period 1
NOT COMPLETED
|
0
|
0
|
|
Part 1 Period 2; Part 2 Period 2
STARTED
|
35
|
38
|
|
Part 1 Period 2; Part 2 Period 2
COMPLETED
|
35
|
38
|
|
Part 1 Period 2; Part 2 Period 2
NOT COMPLETED
|
0
|
0
|
|
Part 1 Period 3
STARTED
|
35
|
0
|
|
Part 1 Period 3
COMPLETED
|
32
|
0
|
|
Part 1 Period 3
NOT COMPLETED
|
3
|
0
|
|
Part 1 Period 4
STARTED
|
32
|
0
|
|
Part 1 Period 4
COMPLETED
|
30
|
0
|
|
Part 1 Period 4
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Part 1 Belumosudil (KD025) QD Dosing
Subjects received a single dose of belumosudil 200 mg on 4 separate occasions, and multiple single doses of itraconazole, rabeprazole and rifampicin, on separate occasions, for 9,4 and 9 consecutive days, respectively.
|
Part 2 Belumosudil (KD025) BID Dosing
Subjects received a twice daily dose of belumosudil 200 mg on 2 separate occasions, and single doses of omeprazole for 4 consecutive days.
|
|---|---|---|
|
Part 1 Period 3
Withdrawal by Subject
|
2
|
0
|
|
Part 1 Period 3
Protocol Violation
|
1
|
0
|
|
Part 1 Period 4
Physician Decision
|
1
|
0
|
|
Part 1 Period 4
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Drug-drug Interaction Between Belumosudil, Itraconazole, Rifampicin, Rabeprazole, and Omeprazole in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
All Subjects Part 1: KD025 QD Dosing
n=35 Participants
Period 1: 200 mg KD025 QD alone; Period 2: 200 mg KD025 QD with Itraconazole; Period 3: 200 mg KD025 QD with Rabeprazole; Period 4: 200 mg KD025 QD with Rifampicin
|
All Subjects in Part 2: KD025 BID Dosing
n=38 Participants
Period 1: 200 mg KD025 BID alone; Period 2: 200 mg KD025 BID with Omeprazole
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
32.6 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
34.7 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
BMI (body mass index)
|
26.81 kg/m^2
STANDARD_DEVIATION 3.00 • n=5 Participants
|
25.94 kg/m^2
STANDARD_DEVIATION 3.36 • n=7 Participants
|
26.36 kg/m^2
STANDARD_DEVIATION 3.20 • n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours post-dosePopulation: Subject in Part 1 who received belumosudil alone, belumosudil with itraconazole, belumosudil with rabeprazole, and belumosudil with rifampicin. The number of subjects who participated in the study may differ from the number of subjects with an observation due to missing samples at critical timepoints or protocol deviations.
Maximum concentration (Cmax) of the parent drug, KD025, Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2) for belumosudil alone, belumosudil + itraconazole, belumosudil + rabeprazole, and belumosudil + rifampicin at 0 to 48 hours post-dose
Outcome measures
| Measure |
Part 1, Period 1: Belumosudil Alone
n=35 Participants
Belumosudil 200 mg single dose on Day 1
|
Part 1, Period 2: Belumosudil + Itraconazole
n=35 Participants
Itraconazole 200 mg QD on Day 1 through Day 7; Belumosudil 200 mg + Itraconazole 200 mg QD on Day 8; Itraconazole 200 mg QD on Day 9
|
Part 1, Period 3: Belumosudil + Rabeprazole
n=32 Participants
Rabeprazole 20 mg BID on Day 1 through Day 3; Belumosudil 200 mg + Rabeprazole 20 mg QD on Day 4
|
Part 1, Period 4: Belumosudil + Rifampicin
n=29 Participants
Rifampicin 600 mg QD on Day 1-9; Belumosudil 200 mg on Day 10.
|
Part 2, Period 1: Belumosudil Only
Belumosudil 200 mg BID (Q12h) fed on a single day, Period 1 Day 1
|
Part 2, Period 2: Belumosudil + Omeprazole
Omeprazole 20 mg QD fasted for 3 days (Period 2, Days -3 to -1); Omeprazole 20 mg QD fasted + Belumosudil 200 mg BID (Q12h) fed on 4th day (Period 2 Day 1)
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Cmax of KD025 and KD025m2 in Part 1
Parent Drug KD025
|
1770 ng/mL
Geometric Coefficient of Variation 31.3
|
2130 ng/mL
Geometric Coefficient of Variation 31.0
|
227 ng/mL
Geometric Coefficient of Variation 58.4
|
712 ng/mL
Geometric Coefficient of Variation 35
|
—
|
—
|
|
Pharmacokinetics: Cmax of KD025 and KD025m2 in Part 1
KD025m2
|
337 ng/mL
Geometric Coefficient of Variation 54.7
|
221 ng/mL
Geometric Coefficient of Variation 60.8
|
23.5 ng/mL
Geometric Coefficient of Variation 70.7
|
148 ng/mL
Geometric Coefficient of Variation 57.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours post-dosePopulation: Subjects in Part 1 who received belumosudil alone and belumosudil with rifampicin. The number of subjects who participated in the study may differ from the number of subjects with an observation due to missing samples at critical timepoints or protocol deviations.
Maximum concentration (Cmax) of Metabolite 1 (KD025m1) for belumosudil alone and for belumosudil + rifampicin up to 48 hours post-dose
Outcome measures
| Measure |
Part 1, Period 1: Belumosudil Alone
n=35 Participants
Belumosudil 200 mg single dose on Day 1
|
Part 1, Period 2: Belumosudil + Itraconazole
n=29 Participants
Itraconazole 200 mg QD on Day 1 through Day 7; Belumosudil 200 mg + Itraconazole 200 mg QD on Day 8; Itraconazole 200 mg QD on Day 9
|
Part 1, Period 3: Belumosudil + Rabeprazole
Rabeprazole 20 mg BID on Day 1 through Day 3; Belumosudil 200 mg + Rabeprazole 20 mg QD on Day 4
|
Part 1, Period 4: Belumosudil + Rifampicin
Rifampicin 600 mg QD on Day 1-9; Belumosudil 200 mg on Day 10.
|
Part 2, Period 1: Belumosudil Only
Belumosudil 200 mg BID (Q12h) fed on a single day, Period 1 Day 1
|
Part 2, Period 2: Belumosudil + Omeprazole
Omeprazole 20 mg QD fasted for 3 days (Period 2, Days -3 to -1); Omeprazole 20 mg QD fasted + Belumosudil 200 mg BID (Q12h) fed on 4th day (Period 2 Day 1)
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Cmax of KD025m1 in Part 1
|
23.2 ng/mL
Geometric Coefficient of Variation 40.0
|
52.5 ng/mL
Geometric Coefficient of Variation 34.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,12.5,13,13.5,14,15,16,17,18,20,22,24,36, and 48 hours post-dosePopulation: Subjects in Part 2 who received belumosudil alone and belumosudil with omeprazole. The number of subjects who participated in the study may differ from the number of subjects with an observation due to missing samples at critical timepoints or protocol deviations.
Maximum concentration (Cmax) of the parent drug (KD025), for Metabolite 1 (KD025m1), and for Metabolite 2 (KD025m2), for belumosudil alone and for belumosudil + omeprazole up to 48 hours post-dose
Outcome measures
| Measure |
Part 1, Period 1: Belumosudil Alone
n=38 Participants
Belumosudil 200 mg single dose on Day 1
|
Part 1, Period 2: Belumosudil + Itraconazole
n=38 Participants
Itraconazole 200 mg QD on Day 1 through Day 7; Belumosudil 200 mg + Itraconazole 200 mg QD on Day 8; Itraconazole 200 mg QD on Day 9
|
Part 1, Period 3: Belumosudil + Rabeprazole
Rabeprazole 20 mg BID on Day 1 through Day 3; Belumosudil 200 mg + Rabeprazole 20 mg QD on Day 4
|
Part 1, Period 4: Belumosudil + Rifampicin
Rifampicin 600 mg QD on Day 1-9; Belumosudil 200 mg on Day 10.
|
Part 2, Period 1: Belumosudil Only
Belumosudil 200 mg BID (Q12h) fed on a single day, Period 1 Day 1
|
Part 2, Period 2: Belumosudil + Omeprazole
Omeprazole 20 mg QD fasted for 3 days (Period 2, Days -3 to -1); Omeprazole 20 mg QD fasted + Belumosudil 200 mg BID (Q12h) fed on 4th day (Period 2 Day 1)
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Cmax of KD025, KD025m1, and KD025m2 in Part 2
Cmax--1st Dose: KD025m2
|
282 ng/mL
Geometric Coefficient of Variation 75.6
|
72.3 ng/mL
Geometric Coefficient of Variation 166.8
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Cmax of KD025, KD025m1, and KD025m2 in Part 2
Cmax--1st dose: KD025
|
1790 ng/mL
Geometric Coefficient of Variation 34.5
|
575 ng/mL
Geometric Coefficient of Variation 145.7
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Cmax of KD025, KD025m1, and KD025m2 in Part 2
Cmax--2nd dose: KD025
|
1760 ng/mL
Geometric Coefficient of Variation 37.0
|
903 ng/mL
Geometric Coefficient of Variation 63.8
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Cmax of KD025, KD025m1, and KD025m2 in Part 2
Cmax--1st Dose: KD025m1
|
23.8 ng/mL
Geometric Coefficient of Variation 39.6
|
18.0 ng/mL
Geometric Coefficient of Variation 54.6
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Cmax of KD025, KD025m1, and KD025m2 in Part 2
Cmax--2nd Dose: KD025m1
|
23.6 ng/mL
Geometric Coefficient of Variation 46.4
|
18.9 ng/mL
Geometric Coefficient of Variation 48.7
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics: Cmax of KD025, KD025m1, and KD025m2 in Part 2
Cmax--2nd Dose: KD025m2
|
257 ng/mL
Geometric Coefficient of Variation 83.9
|
115 ng/mL
Geometric Coefficient of Variation 121.8
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part 1: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours post-dose; Part 2: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,12.5,13,13.5,14,15,16,17,18,20,22,24,36, and 48 hours post-dosePopulation: Subjects in Part 1 who received belumosudil alone, belumosudil with itraconazole, belumosudil with rabeprazole, and belumosudil with rifampicin; Subjects in Part 2 who received belumosudil alone and belumosudil with omeprazole. The number of subjects who participated in the study may differ from the number of subjects with an observation due to missing samples at critical timepoints or protocol deviations.
Area under concentration-time curve from zero hours to infinity (AUC\[0-inf\]) and from zero hours to 24 hours post-dose (AUC\[0-24)) for the parent drug KD025, and Metabolite 2, KD025m2, for subjects up to 48 hours each for Part 1 and for Part 2
Outcome measures
| Measure |
Part 1, Period 1: Belumosudil Alone
n=35 Participants
Belumosudil 200 mg single dose on Day 1
|
Part 1, Period 2: Belumosudil + Itraconazole
n=35 Participants
Itraconazole 200 mg QD on Day 1 through Day 7; Belumosudil 200 mg + Itraconazole 200 mg QD on Day 8; Itraconazole 200 mg QD on Day 9
|
Part 1, Period 3: Belumosudil + Rabeprazole
n=32 Participants
Rabeprazole 20 mg BID on Day 1 through Day 3; Belumosudil 200 mg + Rabeprazole 20 mg QD on Day 4
|
Part 1, Period 4: Belumosudil + Rifampicin
n=29 Participants
Rifampicin 600 mg QD on Day 1-9; Belumosudil 200 mg on Day 10.
|
Part 2, Period 1: Belumosudil Only
n=38 Participants
Belumosudil 200 mg BID (Q12h) fed on a single day, Period 1 Day 1
|
Part 2, Period 2: Belumosudil + Omeprazole
n=38 Participants
Omeprazole 20 mg QD fasted for 3 days (Period 2, Days -3 to -1); Omeprazole 20 mg QD fasted + Belumosudil 200 mg BID (Q12h) fed on 4th day (Period 2 Day 1)
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: AUC(0-inf) and AUC(0-24) of KD025 and KD025 m2 for Subject in Part 1 and Part 2
AUC(0-inf): KD025
|
9080 (ng*h)/mL
Geometric Coefficient of Variation 33.3
|
11200 (ng*h)/mL
Geometric Coefficient of Variation 38.1
|
1680 (ng*h)/mL
Geometric Coefficient of Variation 65.8
|
2500 (ng*h)/mL
Geometric Coefficient of Variation 34.5
|
18800 (ng*h)/mL
Geometric Coefficient of Variation 37.1
|
9880 (ng*h)/mL
Geometric Coefficient of Variation 59.2
|
|
Pharmacokinetics: AUC(0-inf) and AUC(0-24) of KD025 and KD025 m2 for Subject in Part 1 and Part 2
AUC(0-inf): KD025m2
|
1230 (ng*h)/mL
Geometric Coefficient of Variation 69.5
|
843 (ng*h)/mL
Geometric Coefficient of Variation 73.7
|
174 (ng*h)/mL
Geometric Coefficient of Variation 11.1
|
396 (ng*h)/mL
Geometric Coefficient of Variation 50.2
|
1900 (ng*h)/mL
Geometric Coefficient of Variation 90.4
|
1110 (ng*h)/mL
Geometric Coefficient of Variation 30.3
|
|
Pharmacokinetics: AUC(0-inf) and AUC(0-24) of KD025 and KD025 m2 for Subject in Part 1 and Part 2
AUC(0-24): KD025
|
8430 (ng*h)/mL
Geometric Coefficient of Variation 30.5
|
10400 (ng*h)/mL
Geometric Coefficient of Variation 35.8
|
1510 (ng*h)/mL
Geometric Coefficient of Variation 60.7
|
2490 (ng*h)/mL
Geometric Coefficient of Variation 34.1
|
16800 (ng*h)/mL
Geometric Coefficient of Variation 36.4
|
7970 (ng*h)/mL
Geometric Coefficient of Variation 58.9
|
|
Pharmacokinetics: AUC(0-inf) and AUC(0-24) of KD025 and KD025 m2 for Subject in Part 1 and Part 2
AUC(0-24): KD025m2
|
1100 (ng*h)/mL
Geometric Coefficient of Variation 63.7
|
745 (ng*h)/mL
Geometric Coefficient of Variation 70.7
|
110 (ng*h)/mL
Geometric Coefficient of Variation 84.0
|
376 (ng*h)/mL
Geometric Coefficient of Variation 56.7
|
1950 (ng*h)/mL
Geometric Coefficient of Variation 82.3
|
767 (ng*h)/mL
Geometric Coefficient of Variation 115.3
|
PRIMARY outcome
Timeframe: Part 1: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12, and 24 hours post-dose; Part 2: Pre-dose and 0.5,1,1.5,2,3,4,5,6,8,10,12,12.5,13,13.5,14,15,16,17,18,20,22, and 24 hours post-dosePopulation: Subjects in Part 1 who received belumosudil alone and belumosudil with rifampicin; Subjects in Part 2 who received belumosudil alone and belumosudil with omeprazole. The number of subjects who participated in the study may differ from the number of subjects with an observation due to missing samples at critical timepoints or protocol deviations.
Area under concentration-time curve from zero hours to 24 hours post-dose (AUC\[0-24\]) for Metabolite 1, KD025m1, for subjects in Part 1 and for subjects in Part 2
Outcome measures
| Measure |
Part 1, Period 1: Belumosudil Alone
n=27 Participants
Belumosudil 200 mg single dose on Day 1
|
Part 1, Period 2: Belumosudil + Itraconazole
n=29 Participants
Itraconazole 200 mg QD on Day 1 through Day 7; Belumosudil 200 mg + Itraconazole 200 mg QD on Day 8; Itraconazole 200 mg QD on Day 9
|
Part 1, Period 3: Belumosudil + Rabeprazole
n=35 Participants
Rabeprazole 20 mg BID on Day 1 through Day 3; Belumosudil 200 mg + Rabeprazole 20 mg QD on Day 4
|
Part 1, Period 4: Belumosudil + Rifampicin
n=15 Participants
Rifampicin 600 mg QD on Day 1-9; Belumosudil 200 mg on Day 10.
|
Part 2, Period 1: Belumosudil Only
Belumosudil 200 mg BID (Q12h) fed on a single day, Period 1 Day 1
|
Part 2, Period 2: Belumosudil + Omeprazole
Omeprazole 20 mg QD fasted for 3 days (Period 2, Days -3 to -1); Omeprazole 20 mg QD fasted + Belumosudil 200 mg BID (Q12h) fed on 4th day (Period 2 Day 1)
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: AUC(0-24) of KD025m1 for Part 1 and for Part 2
|
75.6 (ng*h)/mL
Geometric Coefficient of Variation 42.1
|
148 (ng*h)/mL
Geometric Coefficient of Variation 41.9
|
138 (ng*h)/mL
Geometric Coefficient of Variation 91.3
|
91.5 (ng*h)/mL
Geometric Coefficient of Variation 76.3
|
—
|
—
|
Adverse Events
Part 1, Period 1: Belumosudil Only
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1, Period 2: Belumosudil + Itraconazole
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 1, Period 3: Belumosudil +Rabeprazole
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1, Period 4: Belumosudil + Rifampicin
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 2, Period 1: Belumosudil Only
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 2, Period 2: Belumosudil + Omeprazole
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1, Period 1: Belumosudil Only
n=35 participants at risk
Belumosudil 200 mg single dose on Day 1
|
Part 1, Period 2: Belumosudil + Itraconazole
n=35 participants at risk
Itraconazole 200 mg QD Day 1-7, Belumosudil 200 mg QD with itraconazole on Day 8, Itraconazole 200 mg QD on Day 9
|
Part 1, Period 3: Belumosudil +Rabeprazole
n=33 participants at risk
Rabeprazole 20 mg BID on Day 1-3, Belumosudil 200 mg + rabeprazole 20 mg QD on Day 4
|
Part 1, Period 4: Belumosudil + Rifampicin
n=32 participants at risk
Rifampicin 600 mg QD on Day 1-9, Belumosudil 200 mg on Day 10
|
Part 2, Period 1: Belumosudil Only
n=38 participants at risk
Belumosudil 200 mg BID (Q12h) fed on a single day, Period 1 Day 1: KD025 200 mg BID
|
Part 2, Period 2: Belumosudil + Omeprazole
n=38 participants at risk
Omeprazole 20 mg QD fasted for 3 days (Period 2 Days -3 to -10, Omeprazole 20 mg QD fasted + Belumosudil 200 mg BID (Q12h) fed on 4th day (Period 2 Day 1)
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
Other adverse events
| Measure |
Part 1, Period 1: Belumosudil Only
n=35 participants at risk
Belumosudil 200 mg single dose on Day 1
|
Part 1, Period 2: Belumosudil + Itraconazole
n=35 participants at risk
Itraconazole 200 mg QD Day 1-7, Belumosudil 200 mg QD with itraconazole on Day 8, Itraconazole 200 mg QD on Day 9
|
Part 1, Period 3: Belumosudil +Rabeprazole
n=33 participants at risk
Rabeprazole 20 mg BID on Day 1-3, Belumosudil 200 mg + rabeprazole 20 mg QD on Day 4
|
Part 1, Period 4: Belumosudil + Rifampicin
n=32 participants at risk
Rifampicin 600 mg QD on Day 1-9, Belumosudil 200 mg on Day 10
|
Part 2, Period 1: Belumosudil Only
n=38 participants at risk
Belumosudil 200 mg BID (Q12h) fed on a single day, Period 1 Day 1: KD025 200 mg BID
|
Part 2, Period 2: Belumosudil + Omeprazole
n=38 participants at risk
Omeprazole 20 mg QD fasted for 3 days (Period 2 Days -3 to -10, Omeprazole 20 mg QD fasted + Belumosudil 200 mg BID (Q12h) fed on 4th day (Period 2 Day 1)
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
8.6%
3/35 • Number of events 3 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
3.0%
1/33 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.6%
1/38 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.6%
1/38 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.6%
1/38 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Nervous system disorders
Headache
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
3.0%
1/33 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
9.4%
3/32 • Number of events 3 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
15.8%
6/38 • Number of events 6 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.6%
1/38 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
5.7%
2/35 • Number of events 2 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
3.1%
1/32 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.6%
1/38 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
General disorders
Fatigue
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
3.0%
1/33 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
3.1%
1/32 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
General disorders
Medical device site rash
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
3.0%
1/33 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
General disorders
Catheter site related reaction
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.6%
1/38 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
General disorders
Feeling hot
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.6%
1/38 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Infections and infestations
Hordeolum
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Infections and infestations
Paronychia
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
3.0%
1/33 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
7.9%
3/38 • Number of events 3 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.6%
1/38 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
3.1%
1/32 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
3.1%
1/32 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
5.7%
2/35 • Number of events 2 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
3.1%
1/32 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.6%
1/38 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
3.0%
1/33 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
3.1%
1/32 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
3.0%
1/33 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
|
Vascular disorders
Hot flush
|
0.00%
0/35 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
2.9%
1/35 • Number of events 1 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/33 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/32 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
0.00%
0/38 • Part 1, Period 1: 1 day Part 1, Period 2: 9 days Part 1, Period 3: 4 days Part 1, Period 4: 10 days Part 2, Period 1: 1 day Part 2, Period 2: 4 days
|
Additional Information
Olivier Schueller, Senior Vice President, CMC & Clinical Pharmacology
Kadmon Corporation
Phone: 833-900-5366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding results. The sponsor cannot require changes to the study results in the communication except to remove sponsor's confidential information. Sponsor cannot unilaterally extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER