Trial Outcomes & Findings for Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis (NCT NCT04396756)
NCT ID: NCT04396756
Last Updated: 2024-06-03
Results Overview
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Up to 4 weeks
Results posted on
2024-06-03
Participant Flow
Participant milestones
| Measure |
PLN-74809 (Part A) - 40 mg
PLN-74809 (Part A): Consists of an up to 28-day screening period, a 4-week treatment period, and a 2-week (+/- 3 days) post-treatment follow-up period.
PLN-74809 tablet administered orally.
Participants took either PLN-74809 40mg or a matching placebo with 100ml water after fasting.
|
PLN-74809 (Part B) - 40 mg
PLN-74809 (Part B): Consists of an up to 28-day screening period, a 12-week treatment period, and a 2-week (+/- 3 days) post-treatment follow-up period.
PLN-74809 tablet administered orally.
Participants took either PLN-74809 40mg or a matching placebo with 240ml water after fasting.
|
PLN-74809 (Part C) - 80 mg
PLN-74809 (Part C): Consists of an up to 28-day screening period, a 12-week treatment period, and a 2-week (+/- 3 days) post-treatment follow-up period.
PLN-74809 tablet administered orally.
Participants took either PLN-74809 80mg or a matching placebo with 240ml water after fasting.
|
PLN-74809 (Part C) - 160 mg
PLN-74809 (Part C): Consists of an up to 28-day screening period, a 12-week treatment period, and a 2-week (+/- 3 days) post-treatment follow-up period.
PLN-74809 tablets administered orally.
Participants took either PLN-74809 160mg or a matching placebo with 240ml water after fasting.
|
PLN-74809 (Part D) -320 mg
PLN-74809 (Part D): Consists of an up to 28-day screening period, at least 24-week treatment period, and a 2-week (+/- 3 days) post-treatment follow-up period.
PLN-74809 tablets administered orally.
Participants took either PLN-74809 320 mg or a matching placebo with 240ml water after fasting.
|
Placebo
Matching placebo tablets administered orally.
Participants took a matching placebo with water after fasting.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
22
|
23
|
22
|
21
|
31
|
|
Overall Study
Received Placebo
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
21
|
23
|
20
|
15
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
2
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
Baseline characteristics by cohort
| Measure |
PLN-74809 (Part A) - 40 mg
n=1 Participants
PLN-74809 (Part A) - 40 mg PLN-74809
|
PLN-74809 (Part B) - 40 mg
n=22 Participants
PLN-74809 (Part B) - 40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
n=23 Participants
PLN-74809 (Part C) - 80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
n=22 Participants
PLN-74809 (Part C) - 160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
n=21 Participants
PLN-74809 (Part D) - 320 mg PLN-74809
|
Placebo
n=31 Participants
Placebo (Part B, C, D)
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION NA • n=5 Participants
|
69.2 years
STANDARD_DEVIATION 7.11 • n=7 Participants
|
74.2 years
STANDARD_DEVIATION 4.70 • n=5 Participants
|
71.5 years
STANDARD_DEVIATION 6.63 • n=4 Participants
|
70.6 years
STANDARD_DEVIATION 7.31 • n=21 Participants
|
72.1 years
STANDARD_DEVIATION 6.20 • n=8 Participants
|
71.4 years
STANDARD_DEVIATION 6.61 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
101 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
119 Participants
n=8 Participants
|
|
Ethnicity (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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
116 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: Safety Population included all participants who took at least 1 dose of study drug.
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Outcome measures
| Measure |
PLN-74809 (Part A) - 40 mg
n=1 Participants
PLN-74809 (Part A) - up to 4 weeks
40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
PLN-74809 (Part C) - up to 12 weeks
80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
PLN-74809 (Part C) - up to 12 weeks
160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks
320 mg PLN-74809
|
Placebo (Part B, C, D)
Placebo (Part B, C) - up to 12 weeks
Placebo (Part D) - at least 24 weeks and up to 48 weeks
|
|---|---|---|---|---|---|
|
Part A - Number of Participants With Treatment-Emergent Adverse Events
|
1 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Population included all participants who took at least 1 dose of study drug.
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Outcome measures
| Measure |
PLN-74809 (Part A) - 40 mg
n=22 Participants
PLN-74809 (Part A) - up to 4 weeks
40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
n=23 Participants
PLN-74809 (Part C) - up to 12 weeks
80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
n=22 Participants
PLN-74809 (Part C) - up to 12 weeks
160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
n=22 Participants
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks
320 mg PLN-74809
|
Placebo (Part B, C, D)
n=31 Participants
Placebo (Part B, C) - up to 12 weeks
Placebo (Part D) - at least 24 weeks and up to 48 weeks
|
|---|---|---|---|---|---|
|
Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events
|
16 Participants
|
15 Participants
|
14 Participants
|
17 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: Safety Population included all participants who took at least 1 dose of study drug.
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Outcome measures
| Measure |
PLN-74809 (Part A) - 40 mg
n=22 Participants
PLN-74809 (Part A) - up to 4 weeks
40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
n=8 Participants
PLN-74809 (Part C) - up to 12 weeks
80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
PLN-74809 (Part C) - up to 12 weeks
160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks
320 mg PLN-74809
|
Placebo (Part B, C, D)
Placebo (Part B, C) - up to 12 weeks
Placebo (Part D) - at least 24 weeks and up to 48 weeks
|
|---|---|---|---|---|---|
|
Part D - Number of Participants With Treatment-Emergent Adverse Events
|
20 Participants
|
7 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: Safety Population included all participants who took at least 1 dose of study drug.
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Outcome measures
| Measure |
PLN-74809 (Part A) - 40 mg
n=1 Participants
PLN-74809 (Part A) - up to 4 weeks
40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
PLN-74809 (Part C) - up to 12 weeks
80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
PLN-74809 (Part C) - up to 12 weeks
160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks
320 mg PLN-74809
|
Placebo (Part B, C, D)
Placebo (Part B, C) - up to 12 weeks
Placebo (Part D) - at least 24 weeks and up to 48 weeks
|
|---|---|---|---|---|---|
|
Part A - Number of Participants With Serious Treatment-Emergent Adverse Events
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Population included all participants who took at least 1 dose of study drug.
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Outcome measures
| Measure |
PLN-74809 (Part A) - 40 mg
n=22 Participants
PLN-74809 (Part A) - up to 4 weeks
40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
n=23 Participants
PLN-74809 (Part C) - up to 12 weeks
80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
n=22 Participants
PLN-74809 (Part C) - up to 12 weeks
160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
n=22 Participants
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks
320 mg PLN-74809
|
Placebo (Part B, C, D)
n=31 Participants
Placebo (Part B, C) - up to 12 weeks
Placebo (Part D) - at least 24 weeks and up to 48 weeks
|
|---|---|---|---|---|---|
|
Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: Safety Population included all participants who took at least 1 dose of study drug.
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Outcome measures
| Measure |
PLN-74809 (Part A) - 40 mg
n=22 Participants
PLN-74809 (Part A) - up to 4 weeks
40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
n=8 Participants
PLN-74809 (Part C) - up to 12 weeks
80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
PLN-74809 (Part C) - up to 12 weeks
160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks
320 mg PLN-74809
|
Placebo (Part B, C, D)
Placebo (Part B, C) - up to 12 weeks
Placebo (Part D) - at least 24 weeks and up to 48 weeks
|
|---|---|---|---|---|---|
|
Part D - Number of Participants With Serious Treatment-Emergent Adverse Events
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4, 1 Hour Post DosePopulation: Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration.
Part A - Assessment of PLN-74809 Total Plasma Concentrations Week 4, 1 Hour Post Dose
Outcome measures
| Measure |
PLN-74809 (Part A) - 40 mg
n=1 Participants
PLN-74809 (Part A) - up to 4 weeks
40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
PLN-74809 (Part C) - up to 12 weeks
80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
PLN-74809 (Part C) - up to 12 weeks
160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks
320 mg PLN-74809
|
Placebo (Part B, C, D)
Placebo (Part B, C) - up to 12 weeks
Placebo (Part D) - at least 24 weeks and up to 48 weeks
|
|---|---|---|---|---|---|
|
Part A - Assessment of PLN-74809 Total Plasma Concentrations
|
829 ng/mL
Standard Deviation NA
SD is NA due to only 1 data point available
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12, 2 Hours Post DosePopulation: Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration.
Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hours Post Dose
Outcome measures
| Measure |
PLN-74809 (Part A) - 40 mg
n=20 Participants
PLN-74809 (Part A) - up to 4 weeks
40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
n=23 Participants
PLN-74809 (Part C) - up to 12 weeks
80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
n=21 Participants
PLN-74809 (Part C) - up to 12 weeks
160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
n=18 Participants
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks
320 mg PLN-74809
|
Placebo (Part B, C, D)
Placebo (Part B, C) - up to 12 weeks
Placebo (Part D) - at least 24 weeks and up to 48 weeks
|
|---|---|---|---|---|---|
|
Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations
|
921.45 ng/mL
Standard Deviation 549.103
|
1731.70 ng/mL
Standard Deviation 875.776
|
2733.71 ng/mL
Standard Deviation 1038.402
|
3742.78 ng/mL
Standard Deviation 1383.345
|
—
|
SECONDARY outcome
Timeframe: Week 24, 2 Hours Post DosePopulation: Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration.
Part D - Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hours Post Dose
Outcome measures
| Measure |
PLN-74809 (Part A) - 40 mg
n=16 Participants
PLN-74809 (Part A) - up to 4 weeks
40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
PLN-74809 (Part C) - up to 12 weeks
80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
PLN-74809 (Part C) - up to 12 weeks
160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks
320 mg PLN-74809
|
Placebo (Part B, C, D)
Placebo (Part B, C) - up to 12 weeks
Placebo (Part D) - at least 24 weeks and up to 48 weeks
|
|---|---|---|---|---|---|
|
Part D - Assessment of PLN-74809 Total Plasma Concentrations
|
4120.63 ng/mL
Standard Deviation 1866.606
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 weeksPopulation: Efficacy modified Intent-to-Treat (mITT) Population includes all randomized participants who do not have FVC values that meet outlier criteria.
Change from Baseline by Visit, Mixed Model for Repeated Measures through Week 12.
Outcome measures
| Measure |
PLN-74809 (Part A) - 40 mg
n=21 Participants
PLN-74809 (Part A) - up to 4 weeks
40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
n=23 Participants
PLN-74809 (Part C) - up to 12 weeks
80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
n=21 Participants
PLN-74809 (Part C) - up to 12 weeks
160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
n=18 Participants
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks
320 mg PLN-74809
|
Placebo (Part B, C, D)
n=25 Participants
Placebo (Part B, C) - up to 12 weeks
Placebo (Part D) - at least 24 weeks and up to 48 weeks
|
|---|---|---|---|---|---|
|
Part B, C, D - Assessment of Change From Baseline in Forced Vital Capacity (FVC)
|
-46.1 mL
Standard Error 39.64
|
25.6 mL
Standard Error 38.57
|
-25.6 mL
Standard Error 40.49
|
29.4 mL
Standard Error 43.35
|
-110.5 mL
Standard Error 36.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 weeksPopulation: Efficacy modified Intent-to-Treat (mITT) Population includes all randomized participants who do not have FVC values that meet outlier criteria.
Change from Baseline by Visit, Mixed Model for Repeated Measures through Week 24.
Outcome measures
| Measure |
PLN-74809 (Part A) - 40 mg
n=16 Participants
PLN-74809 (Part A) - up to 4 weeks
40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
n=6 Participants
PLN-74809 (Part C) - up to 12 weeks
80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
PLN-74809 (Part C) - up to 12 weeks
160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks
320 mg PLN-74809
|
Placebo (Part B, C, D)
Placebo (Part B, C) - up to 12 weeks
Placebo (Part D) - at least 24 weeks and up to 48 weeks
|
|---|---|---|---|---|---|
|
Part D - Assessment of Change From Baseline in Forced Vital Capacity (FVC)
|
-35.9 mL
Standard Error 50.57
|
-109.3 mL
Standard Error 74.93
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 weeksPopulation: Per computed tomography (CT) population includes all randomized participants with evaluable CT scans per the imaging charter.
Quantitative Lung Fibrosis extent (%) measures the percentage of lung tissue that is assessed as fibrotic.
Outcome measures
| Measure |
PLN-74809 (Part A) - 40 mg
n=15 Participants
PLN-74809 (Part A) - up to 4 weeks
40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
n=18 Participants
PLN-74809 (Part C) - up to 12 weeks
80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
n=14 Participants
PLN-74809 (Part C) - up to 12 weeks
160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
n=16 Participants
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks
320 mg PLN-74809
|
Placebo (Part B, C, D)
n=25 Participants
Placebo (Part B, C) - up to 12 weeks
Placebo (Part D) - at least 24 weeks and up to 48 weeks
|
|---|---|---|---|---|---|
|
Part B, C, D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 12
|
3.15 Percentage
Standard Deviation 4.796
|
0.70 Percentage
Standard Deviation 4.194
|
0.00 Percentage
Standard Deviation 3.960
|
0.20 Percentage
Standard Deviation 2.817
|
1.46 Percentage
Standard Deviation 4.951
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 weeksPopulation: Per computed tomography (CT) population includes all randomized participants with evaluable CT scans per the imaging charter.
Quantitative Lung Fibrosis extent (%) measures the percentage of lung tissue that is assessed as fibrotic.
Outcome measures
| Measure |
PLN-74809 (Part A) - 40 mg
n=14 Participants
PLN-74809 (Part A) - up to 4 weeks
40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
n=6 Participants
PLN-74809 (Part C) - up to 12 weeks
80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
PLN-74809 (Part C) - up to 12 weeks
160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks
320 mg PLN-74809
|
Placebo (Part B, C, D)
Placebo (Part B, C) - up to 12 weeks
Placebo (Part D) - at least 24 weeks and up to 48 weeks
|
|---|---|---|---|---|---|
|
Part D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 24
|
1.31 Percentage
Standard Deviation 2.650
|
3.72 Percentage
Standard Deviation 4.381
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 weeksPopulation: Efficacy Intent-to-Treat (ITT) Population includes all randomized participants with evaluable cough scores.
Visual Analog Scale for Cough measures participant reported cough severity on a scale of 0 to 100 with higher scores representative of more severe cough. A negative change from baseline nominally represents reduced cough severity and a positive change from baseline nominally represents increased cough severity.
Outcome measures
| Measure |
PLN-74809 (Part A) - 40 mg
n=21 Participants
PLN-74809 (Part A) - up to 4 weeks
40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
n=23 Participants
PLN-74809 (Part C) - up to 12 weeks
80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
n=21 Participants
PLN-74809 (Part C) - up to 12 weeks
160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
n=18 Participants
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks
320 mg PLN-74809
|
Placebo (Part B, C, D)
n=28 Participants
Placebo (Part B, C) - up to 12 weeks
Placebo (Part D) - at least 24 weeks and up to 48 weeks
|
|---|---|---|---|---|---|
|
Part B,C, D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough
|
1.2 Point
Standard Deviation 20.92
|
0.7 Point
Standard Deviation 13.85
|
3.8 Point
Standard Deviation 26.46
|
-2.9 Point
Standard Deviation 31.19
|
-0.3 Point
Standard Deviation 16.43
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 weeksPopulation: Efficacy Intent-to-Treat (ITT) Population includes all randomized participants with evaluable cough scores.
Visual Analog Scale for Cough measures participant reported cough severity on a scale of 0 to 100 with higher scores representative of more severe cough. A negative change from baseline nominally represents reduced cough severity and a positive change from baseline nominally represents increased cough severity.
Outcome measures
| Measure |
PLN-74809 (Part A) - 40 mg
n=16 Participants
PLN-74809 (Part A) - up to 4 weeks
40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
n=5 Participants
PLN-74809 (Part C) - up to 12 weeks
80 mg PLN-74809
|
PLN-74809 (Part C) - 160 mg
PLN-74809 (Part C) - up to 12 weeks
160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks
320 mg PLN-74809
|
Placebo (Part B, C, D)
Placebo (Part B, C) - up to 12 weeks
Placebo (Part D) - at least 24 weeks and up to 48 weeks
|
|---|---|---|---|---|---|
|
Part D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough
|
-1.9 Point
Standard Deviation 17.70
|
16.8 Point
Standard Deviation 33.78
|
—
|
—
|
—
|
Adverse Events
PLN-74809 (Part A) - 40 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PLN-74809 (Part B) - 40 mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
PLN-74809 (Part C) - 80 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PLN-74809 (Part C) -160 mg
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
PLN-74809 (Part D) - 320 mg
Serious events: 2 serious events
Other events: 18 other events
Deaths: 1 deaths
Placebo
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PLN-74809 (Part A) - 40 mg
n=1 participants at risk
PLN-74809 (Part A) - 40 mg PLN-74809
|
PLN-74809 (Part B) - 40 mg
n=22 participants at risk
PLN-74809 (Part B) - 40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
n=23 participants at risk
PLN-74809 (Part C) - 80 mg PLN-74809
|
PLN-74809 (Part C) -160 mg
n=22 participants at risk
PLN-74809 (Part C) -160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
n=22 participants at risk
PLN-74809 (Part D) - 320 mg PLN-74809
|
Placebo
n=31 participants at risk
Placebo
Placebo
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Bladder dilatation
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
3.2%
1/31 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
3.2%
1/31 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis/Pulmonary fibrosis
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
3.2%
1/31 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Congenital, familial and genetic disorders
Haemorrhagic arteriovenous malformation
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlactacidaemia
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
PLN-74809 (Part A) - 40 mg
n=1 participants at risk
PLN-74809 (Part A) - 40 mg PLN-74809
|
PLN-74809 (Part B) - 40 mg
n=22 participants at risk
PLN-74809 (Part B) - 40 mg PLN-74809
|
PLN-74809 (Part C) - 80 mg
n=23 participants at risk
PLN-74809 (Part C) - 80 mg PLN-74809
|
PLN-74809 (Part C) -160 mg
n=22 participants at risk
PLN-74809 (Part C) -160 mg PLN-74809
|
PLN-74809 (Part D) - 320 mg
n=22 participants at risk
PLN-74809 (Part D) - 320 mg PLN-74809
|
Placebo
n=31 participants at risk
Placebo
Placebo
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.1%
2/22 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
21.7%
5/23 • Number of events 5 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
22.7%
5/22 • Number of events 8 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
31.8%
7/22 • Number of events 11 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
12.9%
4/31 • Number of events 5 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.1%
2/22 • Number of events 5 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.7%
3/31 • Number of events 4 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.1%
2/22 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.1%
2/22 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.1%
2/22 • Number of events 3 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.1%
2/22 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.1%
2/22 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
3.2%
1/31 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.1%
2/22 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
22.7%
5/22 • Number of events 6 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
3.2%
1/31 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
13.6%
3/22 • Number of events 3 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.7%
3/31 • Number of events 3 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis/Pulmonary fibrosis
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
18.2%
4/22 • Number of events 4 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.7%
3/31 • Number of events 3 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.1%
2/22 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
8.7%
2/23 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.1%
2/22 • Number of events 3 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
6.5%
2/31 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.1%
2/22 • Number of events 3 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.1%
2/22 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
6.5%
2/31 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.1%
2/22 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
6.5%
2/31 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
6.5%
2/31 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.7%
3/31 • Number of events 4 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.3%
1/23 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
4.5%
1/22 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
3.2%
1/31 • Number of events 1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
|
Investigations
Amylase increased
|
0.00%
0/1 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/23 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/22 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
9.1%
2/22 • Number of events 2 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
0.00%
0/31 • All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).
All-cause mortality: All Randomized population included all participants who were randomized in the study. Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
|
Additional Information
Gregory P. Cosgrove, MD, Vice President, Clinical Development
Pliant Therapeutics, Inc.
Phone: 1-650-481-6770
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Per protocol, the data generated in this clinical study are the exclusive property of the Sponsor and are confidential. Any publication of the results of this study must be authorized by the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER