Trial Outcomes & Findings for A Study in Healthy People to Test Whether BI 730357 Affects How 4 Other Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Taken up in the Body (NCT NCT04590937)
NCT ID: NCT04590937
Last Updated: 2023-09-06
Results Overview
Area under the concentration-time curve of Metformin in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Metformin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
Results posted on
2023-09-06
Participant Flow
This open-label, non-randomised, 2-period fixed-sequence trial in healthy subjects was to test whether BI 730357 affects how 4 other medicines (rosuvastatin, digoxin, metformin, and furosemide) are taken up in the body.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Cocktail (R) / BI 730357+Cocktail (T)
Each subject participated in 2 treatment periods (Days -1 to 7 in period 1 and Days -7 to Day 8 in Period 2).
In period 1 (Visit 2): the cocktail reference treatment (R) consisting of 1 tablet of 0.25 milligrams (mg) of Digoxin, 0.1 milliliter (mL) oral solution of 1 mg Furosemide, 0.05 mL oral solution of 10 mg Metformin, and 1 film-coated tablet of 10 mg Rosuvastatin were taken orally, each medication as a single dose, once on Day 1 of period 1 (Visit 2).
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) (daily dose 600 mg) from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, the cocktail (1 tablet of 0.25 mg of Digoxin, 0.1 mL oral solution of 1 mg Furosemide, 0.05 mL oral solution of 10 mg Metformin, and 1 film-coated tablet of 10 mg Rosuvastatin) was administered orally once. The BI 730357+ cocktail was the test treatment (T).
The two cocktail administrations were separated by a wash-out period of at least 14 days.
|
|---|---|
|
Period 1 - Cocktail
STARTED
|
15
|
|
Period 1 - Cocktail
COMPLETED
|
15
|
|
Period 1 - Cocktail
NOT COMPLETED
|
0
|
|
Period 2 - BI 730357+Cocktail
STARTED
|
15
|
|
Period 2 - BI 730357+Cocktail
Treated at Least One Dose of BI
|
15
|
|
Period 2 - BI 730357+Cocktail
Treated at Least One Dose of Cocktail+BI
|
14
|
|
Period 2 - BI 730357+Cocktail
COMPLETED
|
14
|
|
Period 2 - BI 730357+Cocktail
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cocktail (R) / BI 730357+Cocktail (T)
Each subject participated in 2 treatment periods (Days -1 to 7 in period 1 and Days -7 to Day 8 in Period 2).
In period 1 (Visit 2): the cocktail reference treatment (R) consisting of 1 tablet of 0.25 milligrams (mg) of Digoxin, 0.1 milliliter (mL) oral solution of 1 mg Furosemide, 0.05 mL oral solution of 10 mg Metformin, and 1 film-coated tablet of 10 mg Rosuvastatin were taken orally, each medication as a single dose, once on Day 1 of period 1 (Visit 2).
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) (daily dose 600 mg) from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, the cocktail (1 tablet of 0.25 mg of Digoxin, 0.1 mL oral solution of 1 mg Furosemide, 0.05 mL oral solution of 10 mg Metformin, and 1 film-coated tablet of 10 mg Rosuvastatin) was administered orally once. The BI 730357+ cocktail was the test treatment (T).
The two cocktail administrations were separated by a wash-out period of at least 14 days.
|
|---|---|
|
Period 2 - BI 730357+Cocktail
COVID-19 related
|
1
|
Baseline Characteristics
A Study in Healthy People to Test Whether BI 730357 Affects How 4 Other Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Taken up in the Body
Baseline characteristics by cohort
| Measure |
Cocktail (R) / BI 730357+Cocktail (T)
n=15 Participants
Each subject participated in 2 treatment periods (Days -1 to 7 in period 1 and Days -7 to Day 8 in Period 2).
In period 1 (Visit 2): the cocktail reference treatment (R) consisting of 1 tablet of 0.25 milligrams (mg) of Digoxin, 0.1 milliliter (mL) oral solution of 1 mg Furosemide, 0.05 mL oral solution of 10 mg Metformin, and 1 film-coated tablet of 10 mg Rosuvastatin were taken orally, each medication as a single dose, once on Day 1 of period 1 (Visit 2).
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) (daily dose 600 mg) from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, the cocktail (1 tablet of 0.25 mg of Digoxin, 0.1 mL oral solution of 1 mg Furosemide, 0.05 mL oral solution of 10 mg Metformin, and 1 film-coated tablet of 10 mg Rosuvastatin) was administered orally once. The BI 730357+ cocktail was the test treatment (T).
The two cocktail administrations were separated by a wash-out period of at least 14 days.
|
|---|---|
|
Age, Continuous
|
34.2 Years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Metformin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis.
Area under the concentration-time curve of Metformin in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean.
Outcome measures
| Measure |
Metformin (Period 1)
n=15 Participants
In period 1 (Visit 2): 0.05 milliliter (mL) oral solution of 10 milligrams (mg) Metformin were taken orally as a single dose once on Day 1 of period 1 (Visit 2).
|
Metformin + BI 730357 (Period 2)
n=14 Participants
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.05 mL oral solution of 10 mg Metformin were administered orally once. The two Metformin administrations were separated by a wash-out period of at least 14 days.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Metformin)
|
1460.83 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.05
|
1434.81 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.05
|
PRIMARY outcome
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Rosuvastatin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis.
Area under the concentration-time curve of Rosuvastatin in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean.
Outcome measures
| Measure |
Metformin (Period 1)
n=14 Participants
In period 1 (Visit 2): 0.05 milliliter (mL) oral solution of 10 milligrams (mg) Metformin were taken orally as a single dose once on Day 1 of period 1 (Visit 2).
|
Metformin + BI 730357 (Period 2)
n=13 Participants
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.05 mL oral solution of 10 mg Metformin were administered orally once. The two Metformin administrations were separated by a wash-out period of at least 14 days.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Rosuvastatin)
|
90.08 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.11
|
110.87 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.12
|
PRIMARY outcome
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Furosemide in both periods plus at 143h in period 1 and at 119h and 167h in period 2.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis.
Area under the concentration-time curve of Furosemide in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean.
Outcome measures
| Measure |
Metformin (Period 1)
n=15 Participants
In period 1 (Visit 2): 0.05 milliliter (mL) oral solution of 10 milligrams (mg) Metformin were taken orally as a single dose once on Day 1 of period 1 (Visit 2).
|
Metformin + BI 730357 (Period 2)
n=13 Participants
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.05 mL oral solution of 10 mg Metformin were administered orally once. The two Metformin administrations were separated by a wash-out period of at least 14 days.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Furosemide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Furosemide)
|
157.57 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.06
|
185.50 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.06
|
PRIMARY outcome
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Digoxin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis.
Area under the concentration-time curve of Digoxin in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean.
Outcome measures
| Measure |
Metformin (Period 1)
n=15 Participants
In period 1 (Visit 2): 0.05 milliliter (mL) oral solution of 10 milligrams (mg) Metformin were taken orally as a single dose once on Day 1 of period 1 (Visit 2).
|
Metformin + BI 730357 (Period 2)
n=14 Participants
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.05 mL oral solution of 10 mg Metformin were administered orally once. The two Metformin administrations were separated by a wash-out period of at least 14 days.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Digoxin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Digoxin)
|
13.34 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.09
|
22.71 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.10
|
PRIMARY outcome
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Metformin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis.
Maximum measured concentration of Metformin in plasma is reported. The geometric mean is actually adjusted geometric mean.
Outcome measures
| Measure |
Metformin (Period 1)
n=15 Participants
In period 1 (Visit 2): 0.05 milliliter (mL) oral solution of 10 milligrams (mg) Metformin were taken orally as a single dose once on Day 1 of period 1 (Visit 2).
|
Metformin + BI 730357 (Period 2)
n=14 Participants
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.05 mL oral solution of 10 mg Metformin were administered orally once. The two Metformin administrations were separated by a wash-out period of at least 14 days.
|
|---|---|---|
|
Maximum Measured Concentration of Metformin in Plasma (Cmax, Metformin)
|
235.86 nanomole / liter (nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.04
|
215.63 nanomole / liter (nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.04
|
PRIMARY outcome
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Rosuvastatin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis.
Maximum measured concentration of Rosuvastatin in plasma is reported. The geometric mean is actually adjusted geometric mean.
Outcome measures
| Measure |
Metformin (Period 1)
n=15 Participants
In period 1 (Visit 2): 0.05 milliliter (mL) oral solution of 10 milligrams (mg) Metformin were taken orally as a single dose once on Day 1 of period 1 (Visit 2).
|
Metformin + BI 730357 (Period 2)
n=14 Participants
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.05 mL oral solution of 10 mg Metformin were administered orally once. The two Metformin administrations were separated by a wash-out period of at least 14 days.
|
|---|---|---|
|
Maximum Measured Concentration of Rosuvastatin in Plasma (Cmax, Rosuvastatin)
|
6.92 nanomole / liter (nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.13
|
9.63 nanomole / liter (nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.13
|
PRIMARY outcome
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Furosemide in both periods plus at 143h in period 1 and at 119h and 167h in period 2.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis.
Maximum measured concentration of Furosemide in plasma is reported. The geometric mean is actually adjusted geometric mean.
Outcome measures
| Measure |
Metformin (Period 1)
n=15 Participants
In period 1 (Visit 2): 0.05 milliliter (mL) oral solution of 10 milligrams (mg) Metformin were taken orally as a single dose once on Day 1 of period 1 (Visit 2).
|
Metformin + BI 730357 (Period 2)
n=14 Participants
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.05 mL oral solution of 10 mg Metformin were administered orally once. The two Metformin administrations were separated by a wash-out period of at least 14 days.
|
|---|---|---|
|
Maximum Measured Concentration of Furosemide in Plasma (Cmax, Furosemide)
|
51.03 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.08
|
57.21 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.09
|
PRIMARY outcome
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Digoxin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis.
Maximum measured concentration of Digoxin in plasma is reported. The geometric mean is actually adjusted geometric mean.
Outcome measures
| Measure |
Metformin (Period 1)
n=15 Participants
In period 1 (Visit 2): 0.05 milliliter (mL) oral solution of 10 milligrams (mg) Metformin were taken orally as a single dose once on Day 1 of period 1 (Visit 2).
|
Metformin + BI 730357 (Period 2)
n=14 Participants
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.05 mL oral solution of 10 mg Metformin were administered orally once. The two Metformin administrations were separated by a wash-out period of at least 14 days.
|
|---|---|---|
|
Maximum Measured Concentration of Digoxin in Plasma (Cmax, Digoxin)
|
0.87 nanomole / liter (nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.16
|
1.40 nanomole / liter (nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.16
|
SECONDARY outcome
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Metformin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis.
Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point is reported. The geometric mean is actually adjusted geometric mean.
Outcome measures
| Measure |
Metformin (Period 1)
n=15 Participants
In period 1 (Visit 2): 0.05 milliliter (mL) oral solution of 10 milligrams (mg) Metformin were taken orally as a single dose once on Day 1 of period 1 (Visit 2).
|
Metformin + BI 730357 (Period 2)
n=14 Participants
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.05 mL oral solution of 10 mg Metformin were administered orally once. The two Metformin administrations were separated by a wash-out period of at least 14 days.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Metformin)
|
1450.30 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.05
|
1424.70 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.05
|
SECONDARY outcome
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Rosuvastatin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis.
Area under the concentration-time curve of Rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point is reported. The geometric mean is actually adjusted geometric mean.
Outcome measures
| Measure |
Metformin (Period 1)
n=15 Participants
In period 1 (Visit 2): 0.05 milliliter (mL) oral solution of 10 milligrams (mg) Metformin were taken orally as a single dose once on Day 1 of period 1 (Visit 2).
|
Metformin + BI 730357 (Period 2)
n=14 Participants
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.05 mL oral solution of 10 mg Metformin were administered orally once. The two Metformin administrations were separated by a wash-out period of at least 14 days.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Rosuvastatin)
|
78.83 hour * nanomole / liter (h * nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.14
|
93.54 hour * nanomole / liter (h * nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.14
|
SECONDARY outcome
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Furosemide in both periods plus at 143h in period 1 and at 119h and 167h in period 2.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis.
Area under the concentration-time curve of Furosemide in plasma over the time interval from 0 to the last quantifiable data point is reported. The geometric mean is actually adjusted geometric mean.
Outcome measures
| Measure |
Metformin (Period 1)
n=15 Participants
In period 1 (Visit 2): 0.05 milliliter (mL) oral solution of 10 milligrams (mg) Metformin were taken orally as a single dose once on Day 1 of period 1 (Visit 2).
|
Metformin + BI 730357 (Period 2)
n=14 Participants
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.05 mL oral solution of 10 mg Metformin were administered orally once. The two Metformin administrations were separated by a wash-out period of at least 14 days.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Furosemide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Furosemide)
|
151.01 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.05
|
172.26 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.06
|
SECONDARY outcome
Timeframe: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Digoxin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set includes all subjects in the Treated Set who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject is included in the PKS, even if he/she contributes only one PK parameter value for one period to the statistical assessment. Only those with non-missing results are included in the analysis.
Area under the concentration-time curve of Digoxin in plasma over the time interval from 0 to the last quantifiable data point is reported. The geometric mean is actually adjusted geometric mean.
Outcome measures
| Measure |
Metformin (Period 1)
n=15 Participants
In period 1 (Visit 2): 0.05 milliliter (mL) oral solution of 10 milligrams (mg) Metformin were taken orally as a single dose once on Day 1 of period 1 (Visit 2).
|
Metformin + BI 730357 (Period 2)
n=14 Participants
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 6 of Visit 3 (13 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, 0.05 mL oral solution of 10 mg Metformin were administered orally once. The two Metformin administrations were separated by a wash-out period of at least 14 days.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Digoxin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Digoxin)
|
11.00 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.10
|
19.11 hour * nanomole / liter (h*nmol/L)
Standard Error NA
Standard Error is adjusted geometric Standard Error = 1.11
|
Adverse Events
Cocktail (Period 1)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cocktail+BI 730357 (Overlap Period)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 730357 (Period 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 730357+Cocktail (Period 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cocktail (Period 1)
n=15 participants at risk
In period 1 (Visit 2): the cocktail reference treatment (R) consisting of 1 tablet of 0.25 milligrams (mg) of Digoxin, 0.1 milliliter (mL) oral solution of 1 mg Furosemide, 0.05 mL oral solution of 10 mg Metformin, and 1 film-coated tablet of 10 mg Rosuvastatin were taken orally, each medication as a single dose, once on Day 1 of period 1 (Visit 2).
|
Cocktail+BI 730357 (Overlap Period)
n=15 participants at risk
This group refers to the time interval where the residual effect period of the 1st dose of cocktail in period 1 overlaps with the start of the dosing of BI 730357, up to 3 days.
3 film-coated tablets of 100 milligrams (mg) BI 730357 were taken orally twice daily (bid) with daily dose 600 mg starting from Day -7 of Visit 3.
|
BI 730357 (Period 2)
n=15 participants at risk
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day -7 until Day 1 of Visit 3 before the first does of combination of BI and cocktail medications (up to 7 days).
|
BI 730357+Cocktail (Period 2)
n=14 participants at risk
In period 2 (Visit 3): 3 film-coated tablets of 100 mg BI 730357 were taken orally twice daily (bid) with daily dose 600 mg from Day 1 until Day 6 of Visit 3 (7 days in total). On Day 1 of Visit 3, 1 hour after the morning dose of BI 730357, the cocktail (1 tablet of 0.25 mg of Digoxin, 0.1 mL oral solution of 1 mg Furosemide, 0.05 mL oral solution of 10 mg Metformin, and 1 film-coated tablet of 10 mg Rosuvastatin) was administered orally once.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
33.3%
5/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
14.3%
2/14 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
7.1%
1/14 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/14 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
6.7%
1/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/14 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
6.7%
1/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/14 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
7.1%
1/14 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
6.7%
1/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/14 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
7.1%
1/14 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
7.1%
1/14 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
6.7%
1/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/14 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/14 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
6.7%
1/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/14 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.7%
1/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/14 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Food aversion
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
6.7%
1/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/14 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
6.7%
1/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/15 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
0.00%
0/14 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 10 days residual effect period (REP) of cocktail, whichever occurs earlier, up to 10 days. Cocktail+BI: the period where the REP of the 1st dose of cocktail overlaps with the start of the dosing of BI, up to 3 days. BI: From 1st dose of BI or end of 10 days REP (whichever occurs later) until 2nd dose of cocktail, up to 7 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days.
Treated set (TS): The treated set includes all subjects who signed informed consent and were treated with at least one dose of study drug.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place