Trial Outcomes & Findings for Bioavailability of Belumosudil (KD025) in Healthy Male Subjects (NCT NCT02557139)
NCT ID: NCT02557139
Last Updated: 2022-05-25
Results Overview
Maximum concentration (Cmax) of parent drug (KD025), Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2) when administering a single dose of belumosudil 200 mg tablet to subjects who are fasting (Regimen A) compared to administering a single dose of belumosudil 200 mg tablet to subjects who are fed (Regimen B) at 48 hours after dosing
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Pre-dose (0), and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post-dose
Results posted on
2022-05-25
Participant Flow
Enrollment: 23 subjects
Participant milestones
| Measure |
Cohort ABC
Period 1: Single-dose Belumosudil 200 mg tablet fasted (Regimen A); Washout; Period 2: Single-dose Belumosudil 200 mg tablet fed (Regimen B); Washout; Period 3: Single-dose Belumosudil two 100-mg capsules, i.e., 200 mg (Regimen C)
|
Cohort BCA
Period 1: Belumosudil 200 mg tablet fed; Washout; Period 2: Belumosudil 200 mg by capsule, i.e., two 100-mg capsules fed; Washout; Period 3: Belumosudil 200 mg tablet fasted
|
Cohort CAB
Period 1: Single-dose Belumosudil 200 mg by capsule, i.e., two 100-mg capsules fed; Washout; Period 2: Single-dose Belumosudil 200 mg tablet fasted; Washout; Period 3: Single-dose Belumosudil 200 mg tablet fed
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
7
|
|
Overall Study
COMPLETED
|
6
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
Reasons for withdrawal
| Measure |
Cohort ABC
Period 1: Single-dose Belumosudil 200 mg tablet fasted (Regimen A); Washout; Period 2: Single-dose Belumosudil 200 mg tablet fed (Regimen B); Washout; Period 3: Single-dose Belumosudil two 100-mg capsules, i.e., 200 mg (Regimen C)
|
Cohort BCA
Period 1: Belumosudil 200 mg tablet fed; Washout; Period 2: Belumosudil 200 mg by capsule, i.e., two 100-mg capsules fed; Washout; Period 3: Belumosudil 200 mg tablet fasted
|
Cohort CAB
Period 1: Single-dose Belumosudil 200 mg by capsule, i.e., two 100-mg capsules fed; Washout; Period 2: Single-dose Belumosudil 200 mg tablet fasted; Washout; Period 3: Single-dose Belumosudil 200 mg tablet fed
|
|---|---|---|---|
|
Overall Study
Significant liver elevation
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Illness of prohibited medication
|
0
|
0
|
1
|
Baseline Characteristics
Bioavailability of Belumosudil (KD025) in Healthy Male Subjects
Baseline characteristics by cohort
| Measure |
Cohort ABC
n=8 Participants
Period 1: Single-dose Belumosudil 200 mg tablet fasted (Regimen A); Washout; Period 2: Single-dose Belumosudil 200 mg tablet fed (Regimen B); Washout; Period 3: Single-dose Belumosudil two 100-mg capsules, i.e., 200 mg (Regimen C)
|
Cohort BCA
n=8 Participants
Period 1: Belumosudil 200 mg tablet fed; Washout; Period 2: Belumosudil 200 mg by capsule, i.e., two 100-mg capsules fed; Washout; Period 3: Belumosudil 200 mg tablet fasted
|
Cohort CAB
n=7 Participants
Period 1: Single-dose Belumosudil 200 mg by capsule, i.e., two 100-mg capsules fed; Washout; Period 2: Single-dose Belumosudil 200 mg tablet fasted; Washout; Period 3: Single-dose Belumosudil 200 mg tablet fed
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.5 Years
n=5 Participants
|
27.5 Years
n=7 Participants
|
46.0 Years
n=5 Participants
|
33.0 Years
n=4 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
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
BMI (body mass index)
|
26.4 kg/m^2
n=5 Participants
|
26.0 kg/m^2
n=7 Participants
|
26.1 kg/m^2
n=5 Participants
|
26.10 kg/m^2
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (0), and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post-dosePopulation: Not all subjects received each regimen.
Maximum concentration (Cmax) of parent drug (KD025), Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2) when administering a single dose of belumosudil 200 mg tablet to subjects who are fasting (Regimen A) compared to administering a single dose of belumosudil 200 mg tablet to subjects who are fed (Regimen B) at 48 hours after dosing
Outcome measures
| Measure |
Regimen A
n=23 Participants
Single-dose belumosudil 200 mg tablet in the fasting state
|
Regimen B
n=20 Participants
Single-dose belumosudil 200 mg tablet in the fed state
Belumosudil Tablet
|
Regimen C
Single-dose belumosudil 200 mg capsule (two 100-mg capsules) in the fed state
|
Overall
Subjects who received Regimen A and/or Regimen B and/or Regimen C
|
|---|---|---|---|---|
|
Pharmacokinetics: Cmax of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
Cmax: KD025m2
|
173 ng/mL
Geometric Coefficient of Variation 122.6
|
412 ng/mL
Geometric Coefficient of Variation 63.0
|
—
|
—
|
|
Pharmacokinetics: Cmax of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
Cmax: KD025
|
821 ng/mL
Geometric Coefficient of Variation 129.5
|
2100 ng/mL
Geometric Coefficient of Variation 49.8
|
—
|
—
|
|
Pharmacokinetics: Cmax of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
Cmax: KD025m1
|
19.4 ng/mL
Geometric Coefficient of Variation 51.6
|
25.8 ng/mL
Geometric Coefficient of Variation 42.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (0), and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post-dosePopulation: Not all subjects in either cohort had all AUC measurements
Area under concentration-time curve from zero to last dose of belumosudil 200 mg tablets (AUC\[0-last\]) and from zero to infinity (AUC\[0-inf\]) for Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2) when administering a single dose of belumosudil 200 mg tablet to subjects who are fasting (Regimen A) compared to administering a single dose of belumosudil 200 mg tablet to subjects who are fed (Regimen B) at 48 hours after dosing
Outcome measures
| Measure |
Regimen A
n=23 Participants
Single-dose belumosudil 200 mg tablet in the fasting state
|
Regimen B
n=20 Participants
Single-dose belumosudil 200 mg tablet in the fed state
Belumosudil Tablet
|
Regimen C
Single-dose belumosudil 200 mg capsule (two 100-mg capsules) in the fed state
|
Overall
Subjects who received Regimen A and/or Regimen B and/or Regimen C
|
|---|---|---|---|---|
|
Pharmacokinetics: AUCs of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
AUC(0-last): KD025m2
|
550 (ng*h)/mL
Geometric Coefficient of Variation 133.3
|
1320 (ng*h)/mL
Geometric Coefficient of Variation 62.6
|
—
|
—
|
|
Pharmacokinetics: AUCs of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
AUC(0-inf): KD025m1
|
153 (ng*h)/mL
Geometric Coefficient of Variation 0
|
98.7 (ng*h)/mL
Geometric Coefficient of Variation 0
|
—
|
—
|
|
Pharmacokinetics: AUCs of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
AUC(0-inf): KD025m2
|
691 (ng*h)/mL
Geometric Coefficient of Variation 76.7
|
1370 (ng*h)/mL
Geometric Coefficient of Variation 62.6
|
—
|
—
|
|
Pharmacokinetics: AUCs of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
AUC(0-last): KD025
|
4520 (ng*h)/mL
Geometric Coefficient of Variation 121.3
|
9750 (ng*h)/mL
Geometric Coefficient of Variation 49.3
|
—
|
—
|
|
Pharmacokinetics: AUCs of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
AUC(0-last): KD025m1
|
19.8 (ng*h)/mL
Geometric Coefficient of Variation 150.6
|
45.2 (ng*h)/mL
Geometric Coefficient of Variation 95.3
|
—
|
—
|
|
Pharmacokinetics: AUCs of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
AUC(0-inf): KD025
|
4910 (ng*h)/mL
Geometric Coefficient of Variation 146.9
|
10100 (ng*h)/mL
Geometric Coefficient of Variation 52.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0), and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post-doseAnalysis of the maximum concentration (Cmax) of the relative bioavailability of Regimen B (belumosudil 200 mg tablet-fed) vs. Regimen A (belumosudil 200 mg tablet-fasting) and for Regimen B vs. Regimen C (belumosudil 200 mg capsule-fed) utilizing the Ratio of the Adjusted Geometric Means at 48 hours after dosing
Outcome measures
| Measure |
Regimen A
n=20 Participants
Single-dose belumosudil 200 mg tablet in the fasting state
|
Regimen B
n=20 Participants
Single-dose belumosudil 200 mg tablet in the fed state
Belumosudil Tablet
|
Regimen C
Single-dose belumosudil 200 mg capsule (two 100-mg capsules) in the fed state
|
Overall
Subjects who received Regimen A and/or Regimen B and/or Regimen C
|
|---|---|---|---|---|
|
Pharmacokinetics: Cmax for the Relative Bioavailability of Regimen B/Regimen A and Regimen B/Regimen C by Ratio of the Adjusted Geometric Means at 48 Hours Post-dose
|
225.02 Ratio of Adjusted Geometric Means
Interval 176.08 to 287.57
|
119.38 Ratio of Adjusted Geometric Means
Interval 93.41 to 152.56
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0), and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post-dosePopulation: Not all subjects were available for all bioavailability measurements.
Analysis of the area under concentration-time curve for zero to infinity (AUC\[0-inf\]), and zero to last dose (AUC\[0-last\]) of the relative bioavailability of Regimen B (belumosudil 200 mg tablet-fed) vs. Regimen A (belumosudil 200 mg tablet-fasting) and for Regimen B vs. Regimen C (belumosudil 200 mg capsule-fed) utilizing the Ratio of the Adjusted Geometric Means at 48 hours after dosing
Outcome measures
| Measure |
Regimen A
n=20 Participants
Single-dose belumosudil 200 mg tablet in the fasting state
|
Regimen B
n=20 Participants
Single-dose belumosudil 200 mg tablet in the fed state
Belumosudil Tablet
|
Regimen C
Single-dose belumosudil 200 mg capsule (two 100-mg capsules) in the fed state
|
Overall
Subjects who received Regimen A and/or Regimen B and/or Regimen C
|
|---|---|---|---|---|
|
Pharmacokinetics: AUCs for the Relative Bioavailability of Regimen B/Regimen A and Regimen B/Regimen C by Ratio of the Adjusted Geometric Means at 48 Hours Post-dose
AUC(0-last)
|
187.92 Ratio of Adjusted Geometric Means
Interval 154.07 to 229.21
|
117.57 Ratio of Adjusted Geometric Means
Interval 96.4 to 143.4
|
—
|
—
|
|
Pharmacokinetics: AUCs for the Relative Bioavailability of Regimen B/Regimen A and Regimen B/Regimen C by Ratio of the Adjusted Geometric Means at 48 Hours Post-dose
AUC(0-inf)
|
179.58 Ratio of Adjusted Geometric Means
Interval 143.16 to 225.26
|
118.43 Ratio of Adjusted Geometric Means
Interval 97.16 to 144.36
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0), and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post-dosePopulation: Based on PK Population: Not all subjects received each regimen.
Maximum concentration (Cmax) of parent drug (KD025), Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2) when administering a single dose of belumosudil 200 mg tablet to subjects who are fasting (Regimen A) compared to administering a single dose of belumosudil 200 mg tablet to subjects who are fed (Regimen B) compared to a single dose of belumosudil 200 mg capsule (two 100-mg capsules) to subjects who are fed (Regimen C) at 48 hours after dosing
Outcome measures
| Measure |
Regimen A
n=23 Participants
Single-dose belumosudil 200 mg tablet in the fasting state
|
Regimen B
n=20 Participants
Single-dose belumosudil 200 mg tablet in the fed state
Belumosudil Tablet
|
Regimen C
n=22 Participants
Single-dose belumosudil 200 mg capsule (two 100-mg capsules) in the fed state
|
Overall
Subjects who received Regimen A and/or Regimen B and/or Regimen C
|
|---|---|---|---|---|
|
Pharmacokinetics: Cmax of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) vs. Dosing Regimen C (Capsules--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
Cmax: Parent Drug KD025
|
821 ng/mL
Geometric Coefficient of Variation 129.5
|
2100 ng/mL
Geometric Coefficient of Variation 49.8
|
1750 ng/mL
Geometric Coefficient of Variation 38.2
|
—
|
|
Pharmacokinetics: Cmax of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) vs. Dosing Regimen C (Capsules--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
Cmax: KD025m1
|
19.4 ng/mL
Geometric Coefficient of Variation 51.6
|
25.8 ng/mL
Geometric Coefficient of Variation 42.0
|
20.6 ng/mL
Geometric Coefficient of Variation 38.2
|
—
|
|
Pharmacokinetics: Cmax of Dosing Regimen A (Tablets--Fasting) vs. Dosing Regimen B (Tablets--Fed) vs. Dosing Regimen C (Capsules--Fed) for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
Cmax: KD025m2
|
173 ng/mL
Geometric Coefficient of Variation 122.6
|
412 ng/mL
Geometric Coefficient of Variation 63.0
|
289 ng/mL
Geometric Coefficient of Variation 76.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0), and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post-dosePopulation: Not all subjects in either cohort had all AUC measurements
Area under concentration curve from zero to last dose (AUC\[0-last\]) and from zero to infinity (AUC\[0-inf\]) for parent drug (KD025), Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2) when administering a single dose of belumosudil 200 mg tablet to subjects who are fasting (Regimen A) compared to administering a single dose of belumosudil 200 mg tablet to subjects who are fed (Regimen B) compared to administering a single dose of 200 mg capsule (two 100-mg capsules) to subjects who are fed at 48 hours after dosing
Outcome measures
| Measure |
Regimen A
n=23 Participants
Single-dose belumosudil 200 mg tablet in the fasting state
|
Regimen B
n=20 Participants
Single-dose belumosudil 200 mg tablet in the fed state
Belumosudil Tablet
|
Regimen C
n=22 Participants
Single-dose belumosudil 200 mg capsule (two 100-mg capsules) in the fed state
|
Overall
Subjects who received Regimen A and/or Regimen B and/or Regimen C
|
|---|---|---|---|---|
|
Pharmacokinetics: AUCs of Regimen A (Tablet--Fasting) vs. Dosing Regimen B (Tablet--Fed) vs. Dosing Regimen C (Capsule--Fed) for KD025, KD025m1, and KD025m2 for Belumosudil 200 mg at 48 Hours Post-dose
AUC(0-last): KD025m1
|
19.8 (ng*h)/mL
Geometric Coefficient of Variation 150.6
|
45.2 (ng*h)/mL
Geometric Coefficient of Variation 95.3
|
33.6 (ng*h)/mL
Geometric Coefficient of Variation 106.9
|
—
|
|
Pharmacokinetics: AUCs of Regimen A (Tablet--Fasting) vs. Dosing Regimen B (Tablet--Fed) vs. Dosing Regimen C (Capsule--Fed) for KD025, KD025m1, and KD025m2 for Belumosudil 200 mg at 48 Hours Post-dose
AUC(0-last): KD025
|
4520 (ng*h)/mL
Geometric Coefficient of Variation 121.3
|
9750 (ng*h)/mL
Geometric Coefficient of Variation 49.3
|
8650 (ng*h)/mL
Geometric Coefficient of Variation 42.7
|
—
|
|
Pharmacokinetics: AUCs of Regimen A (Tablet--Fasting) vs. Dosing Regimen B (Tablet--Fed) vs. Dosing Regimen C (Capsule--Fed) for KD025, KD025m1, and KD025m2 for Belumosudil 200 mg at 48 Hours Post-dose
AUC(0-last): KD025m2
|
550 (ng*h)/mL
Geometric Coefficient of Variation 133.3
|
1320 (ng*h)/mL
Geometric Coefficient of Variation 62.6
|
1000 (ng*h)/mL
Geometric Coefficient of Variation 95.5
|
—
|
|
Pharmacokinetics: AUCs of Regimen A (Tablet--Fasting) vs. Dosing Regimen B (Tablet--Fed) vs. Dosing Regimen C (Capsule--Fed) for KD025, KD025m1, and KD025m2 for Belumosudil 200 mg at 48 Hours Post-dose
AUC(0-inf): KD025
|
4910 (ng*h)/mL
Geometric Coefficient of Variation 146.9
|
10100 (ng*h)/mL
Geometric Coefficient of Variation 52.9
|
8710 (ng*h)/mL
Geometric Coefficient of Variation 42.2
|
—
|
|
Pharmacokinetics: AUCs of Regimen A (Tablet--Fasting) vs. Dosing Regimen B (Tablet--Fed) vs. Dosing Regimen C (Capsule--Fed) for KD025, KD025m1, and KD025m2 for Belumosudil 200 mg at 48 Hours Post-dose
AUC(0-inf): KD025m1
|
153 (ng*h)/mL
Geometric Coefficient of Variation 0
|
98.7 (ng*h)/mL
Geometric Coefficient of Variation 0
|
213 (ng*h)/mL
Geometric Coefficient of Variation 0
|
—
|
|
Pharmacokinetics: AUCs of Regimen A (Tablet--Fasting) vs. Dosing Regimen B (Tablet--Fed) vs. Dosing Regimen C (Capsule--Fed) for KD025, KD025m1, and KD025m2 for Belumosudil 200 mg at 48 Hours Post-dose
AUC(0-inf): KD025m2
|
691 (ng*h)/mL
Geometric Coefficient of Variation 76.7
|
1370 (ng*h)/mL
Geometric Coefficient of Variation 62.6
|
1420 (ng*h)/mL
Geometric Coefficient of Variation 47.7
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0), and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post-dosePopulation: Not all subjects had PK parameter lambda-z analyzed
Slope of the regression line passing through the apparent elimination phase in a concentration-time plot (Lambda-z) for Regimen A, Regimen B, and Regimen C for for the parent drug (KD025), Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2) at 48 hours after dosing
Outcome measures
| Measure |
Regimen A
n=23 Participants
Single-dose belumosudil 200 mg tablet in the fasting state
|
Regimen B
n=20 Participants
Single-dose belumosudil 200 mg tablet in the fed state
Belumosudil Tablet
|
Regimen C
n=22 Participants
Single-dose belumosudil 200 mg capsule (two 100-mg capsules) in the fed state
|
Overall
Subjects who received Regimen A and/or Regimen B and/or Regimen C
|
|---|---|---|---|---|
|
Pharmacokinetics: Lambda-z for Regimens A, B, and C for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
KD025
|
0.0622 1/hour
Standard Deviation 1.5848
|
0.0993 1/hour
Standard Deviation 1.5293
|
0.0967 1/hour
Standard Deviation 1.4594
|
—
|
|
Pharmacokinetics: Lambda-z for Regimens A, B, and C for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
KD025m1
|
0.3618 1/hour
Standard Deviation 0
|
0.3608 1/hour
Standard Deviation 0
|
0.1275 1/hour
Standard Deviation 0
|
—
|
|
Pharmacokinetics: Lambda-z for Regimens A, B, and C for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
KD025m2
|
0.4159 1/hour
Standard Deviation 1.5248
|
0.3291 1/hour
Standard Deviation 1.7326
|
0.2523 1/hour
Standard Deviation 1.7385
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0), and 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours post-dosePopulation: Not all subjects had all PK parameters analyzed
Apparent elimination half-life (t\[1/2\]), mean residence time from zero to last dose (MRT\[0-last\]), and MRT for zero to infinity (MRT\[0-inf\]) for Regimen A, Regimen B, and Regimen C for for the parent drug (KD025), Metabolite 1 (KD025m1), and Metabolite 2 (KD025m2) at 48 hours after dosing
Outcome measures
| Measure |
Regimen A
n=23 Participants
Single-dose belumosudil 200 mg tablet in the fasting state
|
Regimen B
n=20 Participants
Single-dose belumosudil 200 mg tablet in the fed state
Belumosudil Tablet
|
Regimen C
n=22 Participants
Single-dose belumosudil 200 mg capsule (two 100-mg capsules) in the fed state
|
Overall
Subjects who received Regimen A and/or Regimen B and/or Regimen C
|
|---|---|---|---|---|
|
Pharmacokinetics: t(1/2), MRT(0-last), and MRT(0-inf) for Regimens A, B, and C for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
KD025: t(1/2)
|
11.16 Hours
Standard Deviation 1.58
|
6.98 Hours
Standard Deviation 1.53
|
7.16 Hours
Standard Deviation 1.46
|
—
|
|
Pharmacokinetics: t(1/2), MRT(0-last), and MRT(0-inf) for Regimens A, B, and C for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
KD025m2: t(1/2)
|
1.67 Hours
Standard Deviation 1.52
|
2.11 Hours
Standard Deviation 1.73
|
2.75 Hours
Standard Deviation 1.74
|
—
|
|
Pharmacokinetics: t(1/2), MRT(0-last), and MRT(0-inf) for Regimens A, B, and C for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
KD025: MRT(0-last)
|
7.25 Hours
Standard Deviation 1.39
|
5.70 Hours
Standard Deviation 1.27
|
6.21 Hours
Standard Deviation 1.22
|
—
|
|
Pharmacokinetics: t(1/2), MRT(0-last), and MRT(0-inf) for Regimens A, B, and C for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
KD025m1: t(1/2)
|
1.92 Hours
Standard Deviation 0
|
1.92 Hours
Standard Deviation 0
|
5.44 Hours
Standard Deviation 0
|
—
|
|
Pharmacokinetics: t(1/2), MRT(0-last), and MRT(0-inf) for Regimens A, B, and C for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
KD025m1: MRT(0-last)
|
1.70 Hours
Standard Deviation 1.61
|
2.45 Hours
Standard Deviation 1.61
|
2.79 Hours
Standard Deviation 1.57
|
—
|
|
Pharmacokinetics: t(1/2), MRT(0-last), and MRT(0-inf) for Regimens A, B, and C for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
KD025m2: MRT(0-last)
|
3.03 Hours
Standard Deviation 1.32
|
3.99 Hours
Standard Deviation 1.45
|
4.44 Hours
Standard Deviation 1.34
|
—
|
|
Pharmacokinetics: t(1/2), MRT(0-last), and MRT(0-inf) for Regimens A, B, and C for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
KD025: MRT(0-inf)
|
9.35 Hours
Standard Deviation 1.33
|
6.40 Hours
Standard Deviation 1.27
|
7.18 Hours
Standard Deviation 1.24
|
—
|
|
Pharmacokinetics: t(1/2), MRT(0-last), and MRT(0-inf) for Regimens A, B, and C for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
KD025m1: MRT(0-inf)
|
3.38 Hours
Standard Deviation 0
|
4.39 Hours
Standard Deviation 0
|
8.26 Hours
Standard Deviation 0
|
—
|
|
Pharmacokinetics: t(1/2), MRT(0-last), and MRT(0-inf) for Regimens A, B, and C for KD025, KD025m1, and KD025m2 at 48 Hours Post-dose
KD025m2: MRT(0-inf)
|
3.46 Hours
Standard Deviation 1.30
|
4.35 Hours
Standard Deviation 1.46
|
4.86 Hours
Standard Deviation 1.40
|
—
|
SECONDARY outcome
Timeframe: Approximately 1 monthPopulation: All subject who received at least one dose of belumosudil
Number of subjects with treatment-emergent adverse events (TEAEs), severity and relationship to belumosudil, serious adverse events (SAEs), TEAEs leading to withdrawal from study, and deaths. Treatment-emergent adverse events (TEAEs) are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP. Severity: mild = 1; moderate = 2; severe = 3; life-threatening = 4; and death = 5. Related to belumosudil defined as possibly related, probably related, and related.
Outcome measures
| Measure |
Regimen A
n=23 Participants
Single-dose belumosudil 200 mg tablet in the fasting state
|
Regimen B
n=20 Participants
Single-dose belumosudil 200 mg tablet in the fed state
Belumosudil Tablet
|
Regimen C
n=22 Participants
Single-dose belumosudil 200 mg capsule (two 100-mg capsules) in the fed state
|
Overall
n=23 Participants
Subjects who received Regimen A and/or Regimen B and/or Regimen C
|
|---|---|---|---|---|
|
Safety: Number of Subjects With TEAEs and SAEs
At least 1 TEAE
|
6 Participants
|
3 Participants
|
5 Participants
|
9 Participants
|
|
Safety: Number of Subjects With TEAEs and SAEs
Reporting belumosudil-related TEAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety: Number of Subjects With TEAEs and SAEs
TEAEs Leading to Withdrawal
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Safety: Number of Subjects With TEAEs and SAEs
Severe TEAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety: Number of Subjects With TEAEs and SAEs
Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety: Number of Subjects With TEAEs and SAEs
TEAEs Leading to Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 1 monthTotal number of subjects who had treatment-emergent adverse events (TEAEs), TEAEs related to belumosudil, TEAEs leading to withdrawal of subject, severe TEAEs, serious TEAE (SAE), and TEAEs leading to death. Treatment-emergent adverse events (TEAEs) are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP. Severity: mild = 1; moderate = 2; severe = 3; life-threatening = 4; and death = 5. Related to belumosudil defined as possibly related, probably related, and related.
Outcome measures
| Measure |
Regimen A
n=23 Participants
Single-dose belumosudil 200 mg tablet in the fasting state
|
Regimen B
n=20 Participants
Single-dose belumosudil 200 mg tablet in the fed state
Belumosudil Tablet
|
Regimen C
n=22 Participants
Single-dose belumosudil 200 mg capsule (two 100-mg capsules) in the fed state
|
Overall
n=23 Participants
Subjects who received Regimen A and/or Regimen B and/or Regimen C
|
|---|---|---|---|---|
|
Safety: Total Number of Participants With TEAEs, Related TEAEs, Leading to Withdrawal, Severe, Serious, Leading to Death
Severe TEAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety: Total Number of Participants With TEAEs, Related TEAEs, Leading to Withdrawal, Severe, Serious, Leading to Death
Serious TEAEs (SAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety: Total Number of Participants With TEAEs, Related TEAEs, Leading to Withdrawal, Severe, Serious, Leading to Death
TEAEs Leading to Withdrawal
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Safety: Total Number of Participants With TEAEs, Related TEAEs, Leading to Withdrawal, Severe, Serious, Leading to Death
All TEAEs
|
7 Participants
|
3 Participants
|
6 Participants
|
16 Participants
|
|
Safety: Total Number of Participants With TEAEs, Related TEAEs, Leading to Withdrawal, Severe, Serious, Leading to Death
TEAEs Related to Belumosudil
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety: Total Number of Participants With TEAEs, Related TEAEs, Leading to Withdrawal, Severe, Serious, Leading to Death
TEAEs Leading to Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Regimen A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Regimen B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Regimen C
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Regimen A
n=23 participants at risk
Single-dose belumosudil 200 mg tablet in the fasted state
|
Regimen B
n=20 participants at risk
Single-dose belumosudil 200 mg tablet in the fed state
Belumosudil Tablet
|
Regimen C
n=22 participants at risk
Single-dose belumosudil 200 mg capsule (two 100-mg capsules) in the fed state
|
|---|---|---|---|
|
Nervous system disorders
Cervical radiculopathy
|
4.3%
1/23 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/20 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Nervous system disorders
Headache
|
0.00%
0/23 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
5.0%
1/20 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/23 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/20 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/23 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/20 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
General disorders
Fatigue
|
0.00%
0/23 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/20 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
General disorders
Influenza-like illness
|
4.3%
1/23 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/20 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/23 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
5.0%
1/20 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.3%
1/23 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/20 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
1/23 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/20 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Investigations
Blood creatinine phosphokinase increased
|
4.3%
1/23 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/20 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Investigations
Transaminase increased
|
4.3%
1/23 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/20 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Cardiac disorders
Atrioventricular block--2nd degree
|
4.3%
1/23 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/20 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/23 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/20 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal
|
0.00%
0/23 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
5.0%
1/20 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/23 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/20 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 1 month
Adverse events were classified into two categories: 1.Pre-dose AEs: AEs recorded at screening or with a start date and time prior to the first does of IMP and either do not continue after or do not worsen in intensity after the first dose of IMP; 2. Treatment-emergent adverse events (TEAEs): AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
Additional Information
Olivier Schueller, Senior Vice President, CMC & Clinical Pharmacology
Kadmon Corporation, LLC
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