Trial Outcomes & Findings for A Study in Healthy Men to Test Whether Rifampicin Influences the Amount of BI 425809 in the Blood (NCT NCT03082183)

Last Updated: 2026-03-30

Results Overview

This endpoint calculates area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 168 hour time point. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale including subject as random effect and treatment as fixed effect.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 168:00 hours post dose.

Results posted on

2026-03-30

Participant Flow

This is an open-label, two-period, fixed sequence trial in healthy subjects. A total of 16 subjects were entered and completed the trial. The subjects were treated with 1 tablet of 25 milligram (mg) BI 425809 in period 1 and with multiple doses of Rifampicin (Eremfat®) 600 mg and single dose of 25 mg BI 425809 in period 2.

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

Participant milestones
Measure	BI 425809 Alone (Reference, Treatment B) Then BI 425809 + Rifampicin (Test, Treatment A) BI 425809 alone (reference, Treatment B): Subjects were administered with a single dose of 25 mg BI 425809 orally in the morning after an overnight fast for a single day. BI 425809 + Rifampicin (test, Treatment A): Subjects were administered with multiple doses of 1 film coated tablet of Rifampicin (Eremfat®) 600 mg orally in the evening for 10 days and a single dose of 25 mg BI 425809 was administered on the seventh day of Rifampicin (Eremfat®) treatment. The administrations of the single dose of BI 425809 in the first period and in the following combined treatment period were separated by a washout period of at least 49 days.
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 Men to Test Whether Rifampicin Influences the Amount of BI 425809 in the Blood

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 425809 Alone (Reference, Treatment B) Then BI 425809 + Rifampicin (Test, Treatment A) n=16 Participants BI 425809 alone (reference, Treatment B): Subjects were administered with a single dose of 25 mg BI 425809 orally in the morning after an overnight fast for a single day. BI 425809 + Rifampicin (test, Treatment A): Subjects were administered with multiple doses of 1 film coated tablet of Rifampicin (Eremfat®) 600 mg orally in the evening for 10 days and a single dose of 25 mg BI 425809 was administered on the seventh day of Rifampicin (Eremfat®) treatment. The administrations of the single dose of BI 425809 in the first period and in the following combined treatment period were separated by a washout period of at least 49 days.
Age, Continuous	38.1 Years STANDARD_DEVIATION 10.8 • n=4 Participants
Sex: Female, Male Female	0 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants
Race (NIH/OMB) White	16 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00 and 168:00 hours post dose.

Population: Pharmacokinetic analysis set (PKS): All subjects from the treated set who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value in any period that was judged as PK evaluable and was not affected by Protocol Violations (PV) relevant to the statistical evaluation of PK endpoints.

Outcome measures

Outcome measures
Measure	BI 425809 n=16 Participants Subjects were administered with a single dose of 25 mg BI 425809 orally in the morning after an overnight fast for a single day.	BI 425809 + Rifampicin (Eremfat®) n=16 Participants Subjects were administered with multiple doses of 1 film coated tablet of Rifampicin (Eremfat®) 600 mg orally in the evening for 10 days and a single dose of 25 mg BI 425809 was administered on the seventh day of Rifampicin (Eremfat®) treatment.
Area Under the Plasma Concentration-time Curve From 0 to 168 Hours Time Point of BI 425809 (AUC0-168).	8221.87 nanomolehour/Litre (nmolh/L) Standard Error na Adjusted Geometric standard error = 1.063	843.57 nanomolehour/Litre (nmolh/L) Standard Error na Adjusted Geometric standard error = 1.064

PRIMARY outcome

Population: Pharmacokinetic analysis set (PKS): All subjects from the treated set who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value in any period that was judged as PK evaluable and was not affected by PVs relevant to the statistical evaluation of PK endpoints.

This outcome is maximum measured concentration of the BI 425809 in plasma.

Outcome measures

Outcome measures
Measure	BI 425809 n=16 Participants Subjects were administered with a single dose of 25 mg BI 425809 orally in the morning after an overnight fast for a single day.	BI 425809 + Rifampicin (Eremfat®) n=16 Participants Subjects were administered with multiple doses of 1 film coated tablet of Rifampicin (Eremfat®) 600 mg orally in the evening for 10 days and a single dose of 25 mg BI 425809 was administered on the seventh day of Rifampicin (Eremfat®) treatment.
Maximum Concentration of BI 425809 in Plasma (Cmax).	218.07 nanomol / Litre (nmol/L) Standard Error na Adjusted Geometric standard error = 1.059	81.63 nanomol / Litre (nmol/L) Standard Error na Adjusted Geometric standard error = 1.061

SECONDARY outcome

Population: Pharmacokinetic analysis set (PKS): All subjects from the treated set who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value in any period that was judged as PK evaluable and was not affected by PVs relevant to the statistical evaluation of PK endpoints.

This endpoint calculates area under the concentration-time curve of BI 425809 in plasma with and without adminstration of Rifampicin over the time interval from 0 extrapolated to infinity.

Outcome measures

Outcome measures
Measure	BI 425809 n=16 Participants Subjects were administered with a single dose of 25 mg BI 425809 orally in the morning after an overnight fast for a single day.	BI 425809 + Rifampicin (Eremfat®) n=16 Participants Subjects were administered with multiple doses of 1 film coated tablet of Rifampicin (Eremfat®) 600 mg orally in the evening for 10 days and a single dose of 25 mg BI 425809 was administered on the seventh day of Rifampicin (Eremfat®) treatment.
Area Under the Concentration-time Curve of BI 425809 in Plasma With and Without Co-administration of Rifampicin Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).	8595.51 nanomolehour/Litre (nmolh/L) Standard Error na Adjusted Geometric standard error = 1.069	846.13 nanomolehour/Litre (nmolh/L) Standard Error na Adjusted Geometric standard error = 1.071

SECONDARY outcome

Timeframe: Pharmacokinetic samples were collected at 2:00 hour Pre-dose and at 3:00, 6:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 168:00, 216:00, 264:00, 336:00, 408:00, 504:00, 576:00, 672:00, 744:00, 840:00 and 1008:00 hours post dose.

Population: Pharmacokinetic analysis set (PKS): All subjects from the treated set who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value in any period that was judged as PK evaluable and was not affected by PVs relevant to the statistical evaluation of PK endpoints.

Half life is the period of time required for the concentration or amount of drug in the body to be reduced to exactly one-half of a given concentration or amount.

Outcome measures

Outcome measures
Measure	BI 425809 n=16 Participants Subjects were administered with a single dose of 25 mg BI 425809 orally in the morning after an overnight fast for a single day.	BI 425809 + Rifampicin (Eremfat®) Subjects were administered with multiple doses of 1 film coated tablet of Rifampicin (Eremfat®) 600 mg orally in the evening for 10 days and a single dose of 25 mg BI 425809 was administered on the seventh day of Rifampicin (Eremfat®) treatment.
Terminal Half-life of the Metabolite BI 761036 in Plasma (t1/2)	113 Hours (h) Geometric Coefficient of Variation 22.0	—

Adverse Events

BI 425809

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Loading Rifampicin (Eremfat®)

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

BI 425809 + Rifampicin (Eremfat®)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BI 425809 n=16 participants at risk Subjects were administered with a single dose of 25 mg BI 425809 orally in the morning after an overnight fast for a single day.	Loading Rifampicin (Eremfat®) n=16 participants at risk Subjects were administered with multiple doses of 1 film coated tablet of 600 mg Rifampicin (Eremfat®) orally for 6 days, before second administration of BI 425809 was included.	BI 425809 + Rifampicin (Eremfat®) n=16 participants at risk Subjects were administered with multiple doses of 1 film coated tablet of Rifampicin (Eremfat®) 600 mg orally in the evening for 10 days and a single dose of 25 mg BI 425809 was administered on the seventh day of Rifampicin (Eremfat®) treatment.
Gastrointestinal disorders Nausea	0.00% 0/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	0.00% 0/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	6.2% 1/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	0.00% 0/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	6.2% 1/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	6.2% 1/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	0.00% 0/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.
Nervous system disorders Headache	6.2% 1/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	6.2% 1/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	12.5% 2/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.
Nervous system disorders Sciatica	0.00% 0/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	0.00% 0/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	6.2% 1/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.
Nervous system disorders Syncope	0.00% 0/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	6.2% 1/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	0.00% 0/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.
Renal and urinary disorders Chromaturia	0.00% 0/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	100.0% 16/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	0.00% 0/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.2% 1/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	0.00% 0/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	6.2% 1/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	6.2% 1/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 dose of study drug.	0.00% 0/16 • From first drug administration until up to 11 days after last drug administration. All-cause mortality: Up to 23 days. For Adverse Event (AE) assessment reporting group in period 2 was divided into 'loading Rifampicin' which includes the first 6 days of Rifampicin treatment alone and into 'BI 425809+Rifampicin (Eremfat®)' which includes the first administration of BI 425809 and Rifampicin on the same day following a 4 day treatments of Rifampicin+11 days of Residual Effect period. Treated set (TS): all subjects from the ES who were documented to have received at least 1 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