Trial Outcomes & Findings for A Study of RPL554 Drug Administered by Metered Dose Inhaler to Treat Chronic Obstructive Pulmonary Disease (NCT NCT04091360)
NCT ID: NCT04091360
Last Updated: 2022-09-21
Results Overview
Area under the curve from 0 to 12 hours after single dose drug administration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Day 1
Results posted on
2022-09-21
Participant Flow
40 subjects enrolled for Part A and eligible to continue into Part B.
Part A: 40 Patients randomized equally to receive a single dose of RPL554 (0.10, 0.30, 1, 3, or 6 mg) or matching placebo via pressurized metered dose inhaler (pMDI). Patients continued to Part B after Part A completed. Part B: 28 Patients continued to Part B and randomly assigned to 1 of 4 treatment sequences in a crossover design (1-week treatment periods separated by 7-10 day washout). Each sequence included twice daily RPL554 (0.30, 1, or 3 mg) or matching placebo via pMDI.
Participant milestones
| Measure |
0.10 mg/Part A
Part A: single dose of RPL554 via pMDI (double-blind)
|
0.30 mg/Part A
Part A: single dose of RPL554 via pMDI (double-blind)
|
1 mg/Part A
Part A: single dose of RPL554 via pMDI (double-blind)
|
3 mg/Part A
Part A: single dose of RPL554 via pMDI (double-blind)
|
6 mg/Part A
Part A: single dose of RPL554 via pMDI (single-blind)
|
Placebo/Part A
Part A: single dose via pMDI (double-blind)
|
Seq 1/Part B
Part B: 7 day, twice daily dose of RPL554 via pMDI (double-blind) complete block, cross-over.
Seq 1= RPL554 0.30 mg / RPL554 3 mg / Placebo / RPL554 1 mg
|
Seq 2/Part B
Part B: 7 day, twice daily dose of RPL554 via pMDI (double-blind) complete block, cross-over.
Seq 2= RPL554 1 mg / Placebo / RPL554 3 mg / RPL554 0.30 mg.
|
Seq 3/Part B
Part B: 7 day, twice daily dose of RPL554 via pMDI (double-blind) complete block, cross-over.
Seq 3= RPL554 3 mg / RPL554 1 mg / RPL554 0.30 mg / Placebo.
|
Seq 4/Part B
Part B: 7 day, twice daily dose of RPL554 via pMDI (double-blind) complete block, cross-over.
Seq 4= Placebo / RPL554 0.30 mg / RPL554 1 mg / RPL554 3 mg.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A (R, PC, PG) Single Dose
STARTED
|
6
|
7
|
6
|
7
|
7
|
7
|
0
|
0
|
0
|
0
|
|
Part A (R, PC, PG) Single Dose
COMPLETED
|
6
|
7
|
6
|
7
|
7
|
7
|
0
|
0
|
0
|
0
|
|
Part A (R, PC, PG) Single Dose
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (R, PC, XO) Twice Daily for 7 Day
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
7
|
7
|
6
|
|
Part B (R, PC, XO) Twice Daily for 7 Day
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
6
|
4
|
|
Part B (R, PC, XO) Twice Daily for 7 Day
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
0.10 mg/Part A
Part A: single dose of RPL554 via pMDI (double-blind)
|
0.30 mg/Part A
Part A: single dose of RPL554 via pMDI (double-blind)
|
1 mg/Part A
Part A: single dose of RPL554 via pMDI (double-blind)
|
3 mg/Part A
Part A: single dose of RPL554 via pMDI (double-blind)
|
6 mg/Part A
Part A: single dose of RPL554 via pMDI (single-blind)
|
Placebo/Part A
Part A: single dose via pMDI (double-blind)
|
Seq 1/Part B
Part B: 7 day, twice daily dose of RPL554 via pMDI (double-blind) complete block, cross-over.
Seq 1= RPL554 0.30 mg / RPL554 3 mg / Placebo / RPL554 1 mg
|
Seq 2/Part B
Part B: 7 day, twice daily dose of RPL554 via pMDI (double-blind) complete block, cross-over.
Seq 2= RPL554 1 mg / Placebo / RPL554 3 mg / RPL554 0.30 mg.
|
Seq 3/Part B
Part B: 7 day, twice daily dose of RPL554 via pMDI (double-blind) complete block, cross-over.
Seq 3= RPL554 3 mg / RPL554 1 mg / RPL554 0.30 mg / Placebo.
|
Seq 4/Part B
Part B: 7 day, twice daily dose of RPL554 via pMDI (double-blind) complete block, cross-over.
Seq 4= Placebo / RPL554 0.30 mg / RPL554 1 mg / RPL554 3 mg.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B (R, PC, XO) Twice Daily for 7 Day
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Part B (R, PC, XO) Twice Daily for 7 Day
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Part B (R, PC, XO) Twice Daily for 7 Day
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A Study of RPL554 Drug Administered by Metered Dose Inhaler to Treat Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
0.10 mg
n=6 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=6 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
n=7 Participants
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
n=7 Participants
Single dose of placebo via pMDI (double-blind)
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 4.92 • n=5 Participants
|
71.4 years
STANDARD_DEVIATION 1.27 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 7.87 • n=5 Participants
|
67.1 years
STANDARD_DEVIATION 6.72 • n=4 Participants
|
63.1 years
STANDARD_DEVIATION 8.71 • n=21 Participants
|
64.4 years
STANDARD_DEVIATION 6.60 • n=8 Participants
|
66.3 years
STANDARD_DEVIATION 6.67 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
40 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
|
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)
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)
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
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
40 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
|
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
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
7 participants
n=4 Participants
|
7 participants
n=21 Participants
|
7 participants
n=8 Participants
|
40 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic (PK) Analysis Set in Part A: all randomized patients who had blood sampling performed after the single dose of RPL554 and had evaluable PK parameter data. The PK Analysis Set included the 33 patients who received RPL554 in Part A but not the 7 patients in the placebo group.
Area under the curve from 0 to 12 hours after single dose drug administration.
Outcome measures
| Measure |
0.10 mg
n=6 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=6 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
n=7 Participants
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
Single dose of placebo via pMDI (double-blind)
|
|---|---|---|---|---|---|---|
|
Part A: Pharmacokinetic Parameter AUC0-12
|
175 h*pg/mL
Standard Deviation 96.7
|
611 h*pg/mL
Standard Deviation 183
|
1550 h*pg/mL
Standard Deviation 443
|
5860 h*pg/mL
Standard Deviation 3120
|
9360 h*pg/mL
Standard Deviation 8100
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic (PK) Analysis Set in Part A: all randomized patients who had blood sampling performed after the single dose of RPL554 and had evaluable PK parameter data. The PK Analysis Set included the 33 patients who received RPL554 in Part A but not the 7 patients in the placebo group.
Pharmacokinetic Parameter Cmax after a Single Dose
Outcome measures
| Measure |
0.10 mg
n=6 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=6 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
n=7 Participants
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
Single dose of placebo via pMDI (double-blind)
|
|---|---|---|---|---|---|---|
|
Part A: Pharmacokinetic Parameter Cmax
|
39.4 pg/mL
Standard Deviation 16.4
|
138 pg/mL
Standard Deviation 40.9
|
467 pg/mL
Standard Deviation 57.8
|
1520 pg/mL
Standard Deviation 1050
|
2360 pg/mL
Standard Deviation 1430
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic (PK) Analysis Set in Part A: all randomized patients who had blood sampling performed after the single dose of RPL554 and had evaluable PK parameter data. The PK Analysis Set included the 33 patients who received RPL554 in Part A but not the 7 patients in the placebo group.
Area under the curve at maximum concentration 0-24 hrs after single dose drug administration
Outcome measures
| Measure |
0.10 mg
n=5 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=6 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
n=7 Participants
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
Single dose of placebo via pMDI (double-blind)
|
|---|---|---|---|---|---|---|
|
Part A: Pharmacokinetic Parameter AUC0-t
|
208 h*pg/mL
Standard Deviation 119
|
692 h*pg/mL
Standard Deviation 229
|
1680 h*pg/mL
Standard Deviation 559
|
6800 h*pg/mL
Standard Deviation 3770
|
10800 h*pg/mL
Standard Deviation 10100
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic (PK) Analysis Set in Part A: all randomized patients who had blood sampling performed after the single dose of RPL554 and had evaluable PK parameter data. The PK Analysis Set included the 33 patients who received RPL554 in Part A but not the 7 patients in the placebo group.
RPL554 Plasma Pharmacokinetics concentration after single dose
Outcome measures
| Measure |
0.10 mg
n=4 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=6 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
n=7 Participants
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
Single dose of placebo via pMDI (double-blind)
|
|---|---|---|---|---|---|---|
|
Part A: RPL554 Plasma Pharmacokinetic Parameter (Half-life)
|
6.31 h
Standard Deviation 5.18
|
5.32 h
Standard Deviation 3.36
|
3.47 h
Standard Deviation 1.44
|
5.62 h
Standard Deviation 1.7
|
4.44 h
Standard Deviation 2.03
|
—
|
PRIMARY outcome
Timeframe: Day 7Population: Full Analysis Set = number of patients with at least one on treatment value who contributed to the model estimation.
Change from Baseline FEV1 to Peak FEV1 (over 4 hours) after morning dosing on Day 7
Outcome measures
| Measure |
0.10 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
n=23 Participants
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
Single dose of placebo via pMDI (double-blind)
|
|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Peak FEV1 (Over 4 Hours) on Day 7
|
0.189 L
Standard Deviation 0.1624
|
0.261 L
Standard Deviation 0.1597
|
0.310 L
Standard Deviation 0.1511
|
-0.016 L
Standard Deviation 0.1485
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Full analysis includes patients with values at baseline and peak FEV1 (0-4h).
Change from Baseline FEV1 to Peak FEV1 (over 4 hours) After Single Dose
Outcome measures
| Measure |
0.10 mg
n=6 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=6 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
n=7 Participants
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
n=7 Participants
Single dose of placebo via pMDI (double-blind)
|
|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Peak FEV1 (Over 4 Hours) After 1 Dose
|
0.133 L
Standard Deviation 0.1144
|
0.264 L
Standard Deviation 0.1012
|
0.255 L
Standard Deviation 0.0994
|
0.332 L
Standard Deviation 0.2095
|
0.477 L
Standard Deviation 0.1469
|
0.086 L
Standard Deviation 0.0694
|
SECONDARY outcome
Timeframe: Day 1Population: Full analysis set. () () () () () ()
Change from Baseline FEV1 to Average FEV1 (over 4 hours) After Single Dose
Outcome measures
| Measure |
0.10 mg
n=6 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=6 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
n=7 Participants
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
n=7 Participants
Single dose of placebo via pMDI (double-blind)
|
|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Average FEV1 (Over 4 Hours) After 1 Dose
|
0.058 L
Standard Deviation 0.0889
|
0.161 L
Standard Deviation 0.0650
|
0.153 L
Standard Deviation 0.0653
|
0.240 L
Standard Deviation 0.1677
|
0.334 L
Standard Deviation 0.1147
|
-0.011 L
Standard Deviation 0.0805
|
SECONDARY outcome
Timeframe: Day 1Population: Full analysis set.
Change from Baseline FEV1 to Average FEV1 (over 12 hours) After Single Dose
Outcome measures
| Measure |
0.10 mg
n=6 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=6 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
n=7 Participants
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
n=7 Participants
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
n=7 Participants
Single dose of placebo via pMDI (double-blind)
|
|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Average FEV1 (Over 12 Hours) After 1 Dose
|
0.018 L
Standard Deviation 0.0643
|
0.061 L
Standard Deviation 0.0429
|
0.010 L
Standard Deviation 0.0408
|
0.121 L
Standard Deviation 0.1321
|
0.190 L
Standard Deviation 0.1053
|
-0.031 L
Standard Deviation 0.0740
|
SECONDARY outcome
Timeframe: 1 dayNumber of patients with treatment-emergent hematology abnormal laboratory assessments
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 dayNumber of patients with treatment-emergent blood chemistry abnormal laboratory assessments
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 dayNumber of patients with treatment-emergent urinalysis abnormal laboratory assessments
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of treatment to day 1Number of patients with treatment-emergent abnormal vital signs (pulse rate in bpm)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of treatment to day 1Number of patients with treatment-emergent abnormal vital signs (blood pressure in mm Hg)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of treatment to day 1Number of patients with treatment-emergent abnormal ECG parameters, QTcF in msec
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of treatment to day 1Number of patients with treatment-emergent abnormal ECG parameters, heart rate in bpm
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 7Population: Full analysis set.
Change from baseline in average FEV1 (over 4 hours) on Day 7 after morning dose
Outcome measures
| Measure |
0.10 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
n=23 Participants
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
Single dose of placebo via pMDI (double-blind)
|
|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Average FEV1 (Over 4 Hrs) After 7 Days
|
0.083 L
Standard Deviation 0.1223
|
0.161 L
Standard Deviation 0.1686
|
0.206 L
Standard Deviation 0.1470
|
-0.095 L
Standard Deviation 0.1702
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: Full analysis Set.
Change from baseline FEV1 in average FEV1 (over 12 hours) on Day 7 after morning dose
Outcome measures
| Measure |
0.10 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
n=23 Participants
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
Single dose of placebo via pMDI (double-blind)
|
|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Average FEV1 (Over 12 Hours) After 7 Days
|
0.008 L
Standard Deviation 0.1421
|
0.075 L
Standard Deviation 0.1472
|
0.085 L
Standard Deviation 0.1411
|
-0.112 L
Standard Deviation 0.1662
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: Full analysis set.
Change from Baseline FEV1 to Morning Trough FEV1 on Day 7 after morning dose
Outcome measures
| Measure |
0.10 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
n=23 Participants
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
Single dose of placebo via pMDI (double-blind)
|
|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Trough FEV1 After 7 Days
|
-0.051 L
Standard Deviation 0.1254
|
-0.017 L
Standard Deviation 0.1783
|
0.013 L
Standard Deviation 0.1631
|
-0.097 L
Standard Deviation 0.1389
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Full analysis set.
Change from baseline FEV1 in peak FEV1 (over 4 hours) after first dose
Outcome measures
| Measure |
0.10 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=23 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
n=23 Participants
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
Single dose of placebo via pMDI (double-blind)
|
|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Peak FEV1 (Over 4 Hours) After 1st Dose
|
0.253 L
Standard Deviation 0.0772
|
0.311 L
Standard Deviation 0.1532
|
0.337 L
Standard Deviation 0.1108
|
0.079 L
Standard Deviation 0.0914
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Full analysis set.
Change from baseline FEV1 in average FEV1 (over 4 hours) on Day 1
Outcome measures
| Measure |
0.10 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=23 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
n=23 Participants
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
Single dose of placebo via pMDI (double-blind)
|
|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Average FEV1 (Over 4 Hours) After 1st Dose
|
0.144 L
Standard Deviation 0.0762
|
0.204 L
Standard Deviation 0.1162
|
0.224 L
Standard Deviation 0.0905
|
-0.017 L
Standard Deviation 0.1284
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: number of patients with at least one on treatment value who contributed to the model.
Change from baseline FEV1 in average FEV1 (over 12 hours) on Day 1
Outcome measures
| Measure |
0.10 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=23 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
n=23 Participants
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
Single dose of placebo via pMDI (double-blind)
|
|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Average FEV1 (Over 12 Hours) After 1st Dose
|
0.047 L
Standard Deviation 0.0914
|
0.102 L
Standard Deviation 0.1306
|
0.085 L
Standard Deviation 0.0659
|
-0.058 L
Standard Deviation 0.1444
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Patients with onset of action
Determination of onset of action (\>10% increase in FEV1 from pre- to post-first dose, censored at 120 minutes) on Day 1
Outcome measures
| Measure |
0.10 mg
n=18 Participants
Single dose of RPL554 via pMDI (double-blind)
|
0.30 mg
n=19 Participants
Single dose of RPL554 via pMDI (double-blind)
|
1 mg
n=22 Participants
Single dose of RPL554 via pMDI (double-blind)
|
3 mg
Single dose of RPL554 via pMDI (double-blind)
|
6 mg
Single dose of RPL554 via pMDI (single-blind)
|
Placebo
Single dose of placebo via pMDI (double-blind)
|
|---|---|---|---|---|---|---|
|
Part B: RPL554 Plasma Pharmacokinetic Parameter (Onset of Action)
|
37.0 mins
Interval 3.0 to 120.0
|
27.5 mins
Interval 5.0 to 120.0
|
19.0 mins
Interval 5.0 to 91.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 dayNumber of patients with treatment-emergent hematology abnormal laboratory assessments
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 dayNumber of patients with treatment-emergent blood chemistry abnormal laboratory assessments
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 dayNumber of patients with treatment-emergent urinalysis abnormal laboratory assessments
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of treatment to day 1Number of patients with treatment-emergent abnormal vital signs (pulse rate in bpm)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of treatment to day 1Number of patients with treatment-emergent abnormal vital signs (blood pressure in mm Hg)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of treatment to day 70Number of patients with treatment-emergent abnormal ECG parameters, QTcF in msec
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Start of treatment to day 70Number of patients with treatment-emergent abnormal ECG parameters, heart rate in bpm
Outcome measures
Outcome data not reported
Adverse Events
0.10 mg/Part A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
0.30 mg/Part A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1 mg/Part A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
3 mg/Part A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
6 mg/Part A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo/Part A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B/0.30 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B/1 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B/3 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B/Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.10 mg/Part A
n=6 participants at risk
Part A: single dose of RPL554 via pMDI (double-blind)
|
0.30 mg/Part A
n=7 participants at risk
Part A: single dose of RPL554 via pMDI (double-blind)
|
1 mg/Part A
n=6 participants at risk
Part A: single dose of RPL554 via pMDI (double-blind)
|
3 mg/Part A
n=7 participants at risk
Part A: single dose of RPL554 via pMDI (double-blind)
|
6 mg/Part A
n=7 participants at risk
Part A: single dose of RPL554 via pMDI (single-blind)
|
Placebo/Part A
n=7 participants at risk
Part A: single dose via pMDI (double-blind)
|
Part B/0.30 mg
n=24 participants at risk
Part B: 7 day, twice daily dose of RPL554 via pMDI (double-blind) complete block, cross-over.
|
Part B/1 mg
n=23 participants at risk
Part B: 7 day, twice daily dose of RPL554 via pMDI (double-blind) complete block, cross-over.
|
Part B/3 mg
n=23 participants at risk
Part B: 7 day, twice daily dose of RPL554 via pMDI (double-blind) complete block, cross-over.
|
Part B/Placebo
n=25 participants at risk
Part B: 7 day, twice daily dose of placebo via pMDI (double-blind) complete block, cross-over.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
14.3%
1/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
14.3%
1/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
14.3%
1/7 • Part A: 24 hours. Part B: Approximately 70 days
|
14.3%
1/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
14.3%
1/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
14.3%
1/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
16.7%
1/6 • Part A: 24 hours. Part B: Approximately 70 days
|
14.3%
1/7 • Part A: 24 hours. Part B: Approximately 70 days
|
28.6%
2/7 • Part A: 24 hours. Part B: Approximately 70 days
|
14.3%
1/7 • Part A: 24 hours. Part B: Approximately 70 days
|
4.2%
1/24 • Part A: 24 hours. Part B: Approximately 70 days
|
4.3%
1/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
14.3%
1/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
16.7%
1/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
4.0%
1/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
16.7%
1/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
14.3%
1/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
4.2%
1/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
4.0%
1/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
4.3%
1/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
4.0%
1/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
4.2%
1/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
4.3%
1/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
4.0%
1/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
General disorders
Catheter site bruise
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
4.3%
1/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Infections and infestations
Kidney infection
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
4.3%
1/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
4.3%
1/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
4.3%
1/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/6 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/7 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/24 • Part A: 24 hours. Part B: Approximately 70 days
|
4.3%
1/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/23 • Part A: 24 hours. Part B: Approximately 70 days
|
0.00%
0/25 • Part A: 24 hours. Part B: Approximately 70 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place