Trial Outcomes & Findings for A Study in Healthy People to Test Whether BI 730357 Influences the Amount of Caffeine, Warfarin, Omeprazole, and Midazolam in the Blood (NCT NCT04679948)
NCT ID: NCT04679948
Last Updated: 2023-08-14
Results Overview
Area under the concentration-time curve of caffeine in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity, caffeine) is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h after caffeine administration in both periods.
Results posted on
2023-08-14
Participant Flow
This was a phase 1, non-randomised, open-label, 2-treatment, 2-period fixed sequence design trial in healthy people to test whether BI 730357 influences the amount of caffeine, warfarin, omeprazole, and midazolam in the blood.
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 |
Drug Cocktail Alone (R) Then Drug Cocktail + BI 730357 (T)
In period 1: Participants were administered the cocktail reference treatment (R) consisting of 2 tablets of 50 milligrams (mg) (total dose 100mg) of caffeine (Percoffedrinol® N 50 mg Tablets), 2 tablets of 5 mg (total dose 10 mg) of warfarin sodium (Coumadin® 5 mg), 1 tablet of 20 mg of omeprazole (Antra MUPS® 20 mg gastro-resistant tablet), and 1 milliliter (mL) oral solution of 2 mg of midazolam (Midazolam-ratiopharm® 2 mg/mL oral solution), each medication as a single dose, once on Day 1 of period 1 (Visit 2).
In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) (daily dose 600 mg) from Day -14 to Day 6 of Visit 3 (20 days in total). On the 15th day of BI 730357 treatment (Day 1 of Visit 3, 1 h after the morning dose of BI 730357), the cocktail (100 mg caffeine, 10 mg warfarin, 20 mg omeprazole, and 2 mg midazolam) 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 20 days.
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|---|---|
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Period 1
STARTED
|
16
|
|
Period 1
COMPLETED
|
16
|
|
Period 1
NOT COMPLETED
|
0
|
|
Period 2
STARTED
|
16
|
|
Period 2
COMPLETED
|
16
|
|
Period 2
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy People to Test Whether BI 730357 Influences the Amount of Caffeine, Warfarin, Omeprazole, and Midazolam in the Blood
Baseline characteristics by cohort
| Measure |
Drug Cocktail Alone (R) Then Drug Cocktail + BI 730357 (T)
n=16 Participants
In period 1: Participants were administered the cocktail reference treatment (R) consisting of 2 tablets of 50 milligrams (mg) (total dose 100mg) of caffeine (Percoffedrinol® N 50 mg Tablets), 2 tablets of 5 mg (total dose 10 mg) of warfarin sodium (Coumadin® 5 mg), 1 tablet of 20 mg of omeprazole (Antra MUPS® 20 mg gastro-resistant tablet), and 1 milliliter (mL) oral solution of 2 mg of midazolam (Midazolam-ratiopharm® 2 mg/mL oral solution), each medication as a single dose, once on Day 1 of period 1 (Visit 2).
In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) (daily dose 600 mg) from Day -14 to Day 6 of Visit 3 (20 days in total). On the 15th day of BI 730357 treatment (Day 1 of Visit 3, 1 h after the morning dose of BI 730357), the cocktail (100 mg caffeine, 10 mg warfarin, 20 mg omeprazole, and 2 mg midazolam) 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 20 days.
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|---|---|
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Age, Continuous
|
39.2 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 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
|
16 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: Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h after caffeine administration in both periods.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment. Only those with non-missing results are included in the analysis.
Area under the concentration-time curve of caffeine in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity, caffeine) is reported.
Outcome measures
| Measure |
Caffeine (Reference (R))
n=15 Participants
In period 1 (Visit 2): Participants were administered 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) orally as a single dose once on Day 1 of period 1 (Visit 2).
|
BI 730357 + Caffeine (Test (T))
n=15 Participants
In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) with daily dose 600 mg from Day -14 to Day 6 of Visit 3 (20 days in total). On the 15th day of BI 730357 treatment (Day 1 of Visit 3, 1 h after the morning dose of BI 730357), 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) were administered orally once. The two caffeine administrations were separated by a wash-out period of at least 20 days.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Caffeine in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity, Caffeine)
|
84569.29 hours *nanomole/Liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error=1.11
|
94764.64 hours *nanomole/Liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error=1.11
|
PRIMARY outcome
Timeframe: Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h after caffeine administration in both periods.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment. Only those with non-missing results are included in the analysis.
Maximum measured concentration of the caffeine in plasma (Cmax, caffeine) is reported.
Outcome measures
| Measure |
Caffeine (Reference (R))
n=15 Participants
In period 1 (Visit 2): Participants were administered 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) orally as a single dose once on Day 1 of period 1 (Visit 2).
|
BI 730357 + Caffeine (Test (T))
n=15 Participants
In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) with daily dose 600 mg from Day -14 to Day 6 of Visit 3 (20 days in total). On the 15th day of BI 730357 treatment (Day 1 of Visit 3, 1 h after the morning dose of BI 730357), 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) were administered orally once. The two caffeine administrations were separated by a wash-out period of at least 20 days.
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|---|---|---|
|
Maximum Measured Concentration of the Caffeine in Plasma (Cmax, Caffeine)
|
11973.25 nanomole/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error=1.07
|
11583.25 nanomole/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error=1.07
|
PRIMARY outcome
Timeframe: Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 71 h, 95 h, 119 h, 143 h after warfarin administration in both periods.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment.
Warfarin sodium is a racemic mixture of the R-and S-enantiomers. Area under the concentration-time curve of S-warfarin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity,S-warfain) is reported.
Outcome measures
| Measure |
Caffeine (Reference (R))
n=16 Participants
In period 1 (Visit 2): Participants were administered 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) orally as a single dose once on Day 1 of period 1 (Visit 2).
|
BI 730357 + Caffeine (Test (T))
n=16 Participants
In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) with daily dose 600 mg from Day -14 to Day 6 of Visit 3 (20 days in total). On the 15th day of BI 730357 treatment (Day 1 of Visit 3, 1 h after the morning dose of BI 730357), 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) were administered orally once. The two caffeine administrations were separated by a wash-out period of at least 20 days.
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|---|---|---|
|
Area Under the Concentration-time Curve of S-warfarin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity, S-warfarin)
|
55770.25 hours * nanomole/Liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error=1.10
|
61559.60 hours * nanomole/Liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error=1.10
|
PRIMARY outcome
Timeframe: Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 48 h, 71 h, 95 h, 119 h, 143 h after warfarin administration in both periods.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment.
Warfarin sodium is a racemic mixture of the R-and S-enantiomers. Maximum measured concentration of the S-warfarin in plasma (Cmax) is reported.
Outcome measures
| Measure |
Caffeine (Reference (R))
n=16 Participants
In period 1 (Visit 2): Participants were administered 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) orally as a single dose once on Day 1 of period 1 (Visit 2).
|
BI 730357 + Caffeine (Test (T))
n=16 Participants
In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) with daily dose 600 mg from Day -14 to Day 6 of Visit 3 (20 days in total). On the 15th day of BI 730357 treatment (Day 1 of Visit 3, 1 h after the morning dose of BI 730357), 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) were administered orally once. The two caffeine administrations were separated by a wash-out period of at least 20 days.
|
|---|---|---|
|
Maximum Measured Concentration of the S-warfarin in Plasma (Cmax, S-warfarin)
|
1622.94 nanomole/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error=1.05
|
1760.38 nanomole/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error=1.05
|
PRIMARY outcome
Timeframe: Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h after omeprazole administration in both periods.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment. Only those with non-missing results are included in the analysis.
Area under the concentration-time curve of omeprazole in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity, omeprazole) is reported.
Outcome measures
| Measure |
Caffeine (Reference (R))
n=13 Participants
In period 1 (Visit 2): Participants were administered 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) orally as a single dose once on Day 1 of period 1 (Visit 2).
|
BI 730357 + Caffeine (Test (T))
n=12 Participants
In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) with daily dose 600 mg from Day -14 to Day 6 of Visit 3 (20 days in total). On the 15th day of BI 730357 treatment (Day 1 of Visit 3, 1 h after the morning dose of BI 730357), 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) were administered orally once. The two caffeine administrations were separated by a wash-out period of at least 20 days.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Omeprazole in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity, Omeprazole)
|
933.62 hours * nanomole/Liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error=1.22
|
931.22 hours * nanomole/Liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error=1.23
|
PRIMARY outcome
Timeframe: Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h after omeprazole administration in both periods.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment.
Maximum measured concentration of omeprazole in plasma (Cmax, omeprazole) is reported.
Outcome measures
| Measure |
Caffeine (Reference (R))
n=16 Participants
In period 1 (Visit 2): Participants were administered 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) orally as a single dose once on Day 1 of period 1 (Visit 2).
|
BI 730357 + Caffeine (Test (T))
n=16 Participants
In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) with daily dose 600 mg from Day -14 to Day 6 of Visit 3 (20 days in total). On the 15th day of BI 730357 treatment (Day 1 of Visit 3, 1 h after the morning dose of BI 730357), 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) were administered orally once. The two caffeine administrations were separated by a wash-out period of at least 20 days.
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|---|---|---|
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Maximum Measured Concentration of Omeprazole in Plasma (Cmax, Omeprazole)
|
504.07 nanomole/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error=1.28
|
359.50 nanomole/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error=1.28
|
PRIMARY outcome
Timeframe: Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h after midazolam administration in both periods.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment.
Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity, midazolam) is reported.
Outcome measures
| Measure |
Caffeine (Reference (R))
n=16 Participants
In period 1 (Visit 2): Participants were administered 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) orally as a single dose once on Day 1 of period 1 (Visit 2).
|
BI 730357 + Caffeine (Test (T))
n=16 Participants
In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) with daily dose 600 mg from Day -14 to Day 6 of Visit 3 (20 days in total). On the 15th day of BI 730357 treatment (Day 1 of Visit 3, 1 h after the morning dose of BI 730357), 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) were administered orally once. The two caffeine administrations were separated by a wash-out period of at least 20 days.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity, Midazolam)
|
56.81 hours * nanomole/Liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error=1.07
|
72.07 hours * nanomole/Liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error=1.07
|
PRIMARY outcome
Timeframe: Within 2 hours (h) predose for period 1, within 15 minutes predose for period 2 and 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h after midazolam administration in both periods.Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary and was not excluded due to a clinical trial protocol (CTP) deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment.
Maximum measured concentration of midazolam in plasma (Cmax, midazolam) is reported.
Outcome measures
| Measure |
Caffeine (Reference (R))
n=16 Participants
In period 1 (Visit 2): Participants were administered 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) orally as a single dose once on Day 1 of period 1 (Visit 2).
|
BI 730357 + Caffeine (Test (T))
n=16 Participants
In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) with daily dose 600 mg from Day -14 to Day 6 of Visit 3 (20 days in total). On the 15th day of BI 730357 treatment (Day 1 of Visit 3, 1 h after the morning dose of BI 730357), 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg tablets) were administered orally once. The two caffeine administrations were separated by a wash-out period of at least 20 days.
|
|---|---|---|
|
Maximum Measured Concentration of Midazolam in Plasma (Cmax, Midazolam)
|
19.09 nanomole/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error=1.09
|
24.87 nanomole/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error=1.09
|
Adverse Events
Cocktail (Period 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 730357 (Period 2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 730357 + Cocktail (Period 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 730357 Total
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cocktail (Period 1)
n=16 participants at risk
In period 1 participants were administered the cocktail reference treatment (R) consisting of 2 tablets of 50 milligrams (mg) (total dose 100 mg) of caffeine (Percoffedrinol® N 50 mg Tablets), 2 tablets of 5 mg (total dose 10 mg) of warfarin sodium (Coumadin® 5 mg), 1 tablet of 20 mg of omeprazole (Antra MUPS® 20 mg gastro-resistant tablet), and 1 milliliter (mL) oral solution of 2 mg of midazolam (Midazolam-ratiopharm® 2 mg/mL oral solution), each medication as a single dose, once on Day 1 of period 1 (Visit 2).
|
BI 730357 (Period 2)
n=16 participants at risk
In period 2 (Visit 3) participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) (daily dose 600 mg) from Day -14 until Day 1 of Visit 3, before the first dose of combination of BI and cocktail medications, (up to 14 days).
|
BI 730357 + Cocktail (Period 2)
n=16 participants at risk
In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) (daily dose 600 mg) from Day 1 to Day 6 of Visit 3. On Day 1 of Visit 3, 1 h after the morning dose of BI 730357), the drug cocktail (100 mg caffeine, 10 mg warfarin, 20 mg omeprazole, and 2 mg midazolam) was administered orally once.
|
BI 730357 Total
n=16 participants at risk
In period 2 (Visit 3): Participants were administered 3 film-coated tablets of 100 mg BI 730357 orally twice daily (bid) (daily dose 600 mg) from Day -14 to Day 6 of Visit 3 (20 days in total).
The total number of adverse events due to BI 730357 in the second period is reported.
|
|---|---|---|---|---|
|
Eye disorders
Blepharospasm
|
0.00%
0/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
6.2%
1/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
6.2%
1/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
6.2%
1/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
6.2%
1/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
|
General disorders
Vessel puncture site haematoma
|
6.2%
1/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
6.2%
1/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
0.00%
0/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial drug.
|
6.2%
1/16 • Cocktail: From 1st dose of cocktail until 1st dose of BI 730357 (BI) or end of 7 days residual effect period (REP) of cocktail, up to 7 days. BI: From 1st dose of BI until 2nd dose of cocktail, up to 14 days. BI+Cocktail: From 2nd dose of cocktail until last dose of BI+7 days of REP, up to 13 days. BI total: From 1st dose of BI until last dose of BI+7 days of REP, up to 27 days.
Treated set (TS): The TS included all subjects who were entered and treated with at least 1 dose of trial 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