Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics and Effect on Inflammation of Oral BI 1026706 in Patients With COPD (NCT NCT02642614)
NCT ID: NCT02642614
Last Updated: 2019-08-05
Results Overview
Safety and tolerability of BI 1026706, as assessed by frequency (in percent) of patients with treatment-emergent adverse events (TEAEs) over the treatment period.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
120 participants
Primary outcome timeframe
From first drug administration until 4 days after last drug administration, up to 32 days
Results posted on
2019-08-05
Participant Flow
Double dummy trial, 2 different type of medication were dispensed to the patient with the help of two different bottles: Bottle 1 - 5 mg OR 25 mg BI 1026706 tablets or placebo tablets matching 5 mg and 25 mg BI 1026706 tablets, Bottle 2 -100 mg tablets or Placebo tablets matching 100 mg BI 1026706 tablets.
All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be entered in to the trial if any of the specific entry criteria was violated.
Participant milestones
| Measure |
Placebo
Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
|
5 Milligram BI 1026706
Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
25 Milligram BI 1026706
Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
100 Milligram BI 1026706
Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
27
|
28
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
|
5 Milligram BI 1026706
Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
25 Milligram BI 1026706
Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
100 Milligram BI 1026706
Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics and Effect on Inflammation of Oral BI 1026706 in Patients With COPD
Baseline characteristics by cohort
| Measure |
Placebo
n=30 Participants
Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
|
5 Milligram BI 1026706
n=30 Participants
Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
25 Milligram BI 1026706
n=30 Participants
Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
100 Milligram BI 1026706
n=30 Participants
Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.9 Years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
65.7 Years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
65.3 Years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
62.5 Years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
64.3 Years
STANDARD_DEVIATION 7.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From first drug administration until 4 days after last drug administration, up to 32 daysPopulation: Treated set (TS): The TS included all patients who were randomized and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patient received.
Safety and tolerability of BI 1026706, as assessed by frequency (in percent) of patients with treatment-emergent adverse events (TEAEs) over the treatment period.
Outcome measures
| Measure |
Placebo
n=30 Participants
Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
|
5 Milligram BI 1026706
n=30 Participants
Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
25 Milligram BI 1026706
n=30 Participants
Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
100 Milligram BI 1026706
n=30 Participants
Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
|---|---|---|---|---|
|
Safety and Tolerability of BI 1026706, as Assessed by Frequency (in Percent) of Patients With Treatment Emergent Adverse Events (TEAEs) Over the Treatment Period.
|
60.0 Percentage of Patients
|
46.7 Percentage of Patients
|
66.7 Percentage of Patients
|
53.3 Percentage of Patients
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Treated set including participants with available data for the endpoint percent change in absolute number of neutrophil in sputum at the end of the planned treatment period
Change in Absolute Number of Neutrophil in Sputum at the end of the planned treatment period
Outcome measures
| Measure |
Placebo
n=23 Participants
Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
|
5 Milligram BI 1026706
n=22 Participants
Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
25 Milligram BI 1026706
n=25 Participants
Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
100 Milligram BI 1026706
n=25 Participants
Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
|---|---|---|---|---|
|
Change in Absolute Number of Neutrophil in Sputum at the End of the Planned Treatment Period
|
2.12 10^6 cells/ milliliter (mL)
Standard Error 0.47
|
3.37 10^6 cells/ milliliter (mL)
Standard Error 0.79
|
3.35 10^6 cells/ milliliter (mL)
Standard Error 0.73
|
3.06 10^6 cells/ milliliter (mL)
Standard Error 0.66
|
SECONDARY outcome
Timeframe: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.Population: Extensive pharmacokinetic set (ePKS): The ePKS included all patients in the PKS who signed the informed consent for participating in the extensive PK sub-study.
Maximum measured concentration of BI 1026706 in plasma (Cmax) after the first dose (morning of Day 1)
Outcome measures
| Measure |
Placebo
n=10 Participants
Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
|
5 Milligram BI 1026706
n=11 Participants
Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
25 Milligram BI 1026706
n=11 Participants
Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
100 Milligram BI 1026706
Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
|---|---|---|---|---|
|
Maximum Measured Concentration of BI 1026706 in Plasma (Cmax) After the First Dose (Morning of Day 1)
|
39.0 nanomoles (nmol) / litre (L)
Geometric Coefficient of Variation 47.7
|
145 nanomoles (nmol) / litre (L)
Geometric Coefficient of Variation 37.8
|
524 nanomoles (nmol) / litre (L)
Geometric Coefficient of Variation 39.0
|
—
|
SECONDARY outcome
Timeframe: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.Population: ePKS
Time from dosing to maximum concentration of BI 1026706 in plasma (Tmax) after the first dose (morning of Day 1)
Outcome measures
| Measure |
Placebo
n=10 Participants
Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
|
5 Milligram BI 1026706
n=11 Participants
Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
25 Milligram BI 1026706
n=11 Participants
Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
100 Milligram BI 1026706
Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
|---|---|---|---|---|
|
Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax) After the First Dose (Morning of Day 1)
|
1.00 hour
Full Range 47.7 • Interval 0.5 to 2.0
|
1.02 hour
Full Range 37.8 • Interval 0.5 to 3.0
|
1.00 hour
Full Range 39.0 • Interval 0.483 to 3.0
|
—
|
SECONDARY outcome
Timeframe: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.Population: ePKS
Area under the concentration-time curve of BI 1026706 in plasma (AUC 0-12h) after the first dose (morning of Day 1)
Outcome measures
| Measure |
Placebo
n=10 Participants
Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
|
5 Milligram BI 1026706
n=11 Participants
Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
25 Milligram BI 1026706
n=11 Participants
Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
100 Milligram BI 1026706
Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1026706 in Plasma (AUC 0-12h) After the First Dose (Morning of Day 1)
|
138 nanomoles (nmol) * hour (h) / litre (L)
Geometric Coefficient of Variation 58.2 • Interval 0.5 to 2.0
|
489 nanomoles (nmol) * hour (h) / litre (L)
Geometric Coefficient of Variation 44.4 • Interval 0.5 to 3.0
|
1840 nanomoles (nmol) * hour (h) / litre (L)
Geometric Coefficient of Variation 42.7 • Interval 0.483 to 3.0
|
—
|
SECONDARY outcome
Timeframe: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.Population: ePKS including participants with available data for this endpoint
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau (Cmax, ss) after the last dose (morning of Day 28)
Outcome measures
| Measure |
Placebo
n=9 Participants
Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
|
5 Milligram BI 1026706
n=9 Participants
Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
25 Milligram BI 1026706
n=10 Participants
Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
100 Milligram BI 1026706
Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
|---|---|---|---|---|
|
Maximum Measured Concentration of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (Cmax, ss) After the Last Dose (Morning of Day 28)
|
51.2 nmol/L
Geometric Coefficient of Variation 26.4 • Interval 0.5 to 2.0
|
185 nmol/L
Geometric Coefficient of Variation 34.7 • Interval 0.5 to 3.0
|
870 nmol/L
Geometric Coefficient of Variation 37.9 • Interval 0.483 to 3.0
|
—
|
SECONDARY outcome
Timeframe: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.Population: ePKS including participants with available data for this endpoint
Time from dosing to maximum concentration of BI 1026706 in plasma (Tmax, ss) after the last dose (morning of Day 28)
Outcome measures
| Measure |
Placebo
n=9 Participants
Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
|
5 Milligram BI 1026706
n=9 Participants
Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
25 Milligram BI 1026706
n=10 Participants
Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
100 Milligram BI 1026706
Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
|---|---|---|---|---|
|
Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax, ss) After the Last Dose (Morning of Day 28)
|
1.00 hour
Full Range 26.4 • Interval 0.5 to 3.0
|
1.50 hour
Full Range 34.7 • Interval 1.0 to 3.0
|
0.767 hour
Full Range 37.9 • Interval 0.5 to 3.0
|
—
|
SECONDARY outcome
Timeframe: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.Population: ePKS including participants with available data for this endpoint
Area under the concentration-time curve of BI 1026706 in plasma at steady state over a uniform dosing interval tau (AUC tau, ss) after the last dose (morning of Day 28)
Outcome measures
| Measure |
Placebo
n=9 Participants
Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
|
5 Milligram BI 1026706
n=9 Participants
Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
25 Milligram BI 1026706
n=10 Participants
Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
100 Milligram BI 1026706
Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUC Tau, ss) After the Last Dose (Morning of Day 28)
|
197 nmol*h/L
Geometric Coefficient of Variation 47.1 • Interval 0.5 to 3.0
|
781 nmol*h/L
Geometric Coefficient of Variation 40.7 • Interval 1.0 to 3.0
|
3850 nmol*h/L
Geometric Coefficient of Variation 34.3 • Interval 0.5 to 3.0
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
5 Milligram BI 1026706
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
25 Milligram BI 1026706
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
100 Milligram BI 1026706
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=30 participants at risk
Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
|
5 Milligram BI 1026706
n=30 participants at risk
Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
25 Milligram BI 1026706
n=30 participants at risk
Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
100 Milligram BI 1026706
n=30 participants at risk
Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
|---|---|---|---|---|
|
Nervous system disorders
Visual field defect
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
3.3%
1/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
3.3%
1/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
3.3%
1/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
Other adverse events
| Measure |
Placebo
n=30 participants at risk
Patients received one placebo tablet (twice daily (BID) matching the 5 and 25 milligram (mg) tablets and one placebo tablet matching the 100 mg tablet orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication. In the twice daily (BID) dosing regimen, the patient had to take 2 tablets in the morning and 2 tablets in the evening.
|
5 Milligram BI 1026706
n=30 participants at risk
Patients received BI 1026706 (5 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
25 Milligram BI 1026706
n=30 participants at risk
Patients received BI 1026706 (25 milligram (mg) twice daily (BID) along with placebo matching the 100 mg tablet) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
100 Milligram BI 1026706
n=30 participants at risk
Patients received BI 1026706 (100 milligram (mg) twice daily (BID) along with placebo matching the 5 and 25 mg tablets) film-coated tablet administered orally with water with or without food (except on the morning of Days 1 and 28 when patients were to fast overnight for at least 8 hours before administration of trial medication) for 28 days, with end-of-trial visit 5 to 10 days after last administration of trial medication.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
1/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
3.3%
1/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
13.3%
4/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
6.7%
2/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
6.7%
2/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
3.3%
1/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
6.7%
2/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
6.7%
2/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
3.3%
1/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
10.0%
3/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
|
Infections and infestations
Oral herpes
|
6.7%
2/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
3.3%
1/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
|
Infections and infestations
Rhinitis
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
6.7%
2/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
|
Injury, poisoning and procedural complications
Procedural complication
|
10.0%
3/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
10.0%
3/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
10.0%
3/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
10.0%
3/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
|
Investigations
Forced expiratory volume decreased
|
26.7%
8/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
26.7%
8/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
10.0%
3/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
13.3%
4/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
2/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
3.3%
1/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
3.3%
1/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
|
Nervous system disorders
Headache
|
13.3%
4/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
16.7%
5/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
10.0%
3/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
2/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
3.3%
1/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
0.00%
0/30 • From first drug administration until 4 days after last drug administration, up to 32 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER