Healthy
Conditions
Brief summary
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics of BI 3006337 in healthy male subjects following subcutaneous administration of single-rising doses.
Interventions
DRUGBI 3006337
BI 3006337
DRUGPlacebo
Placebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Temperature, blood pressure (BP), pulse rate (PR)), 12-lead ECG, and clinical laboratory tests * Age of ≥18 to ≤55 years at screening (SCR) * BMI of ≥20.0 to \<32.0 kg/m2 at SCR * A minimum absolute body weight (BW) of 70 kilograms (kg) at SCR * Male subjects who meet any of the following criteria from the administration of trial medication until 30 days after administration of trial medication: * Use of adequate contraception, e.g. any of the following methods (of female partners) plus condom or sexually abstinence (if lifestyle-related): implants, injectables, vaginal contraceptives, intrauterine device, oral contraception (failure rate \<1%). In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. * Surgically sterilised/vasectomised (including hysterectomy with or without bilateral salpingectomy or bilateral oophorectomy of female partner. In case of salpingectomy or oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment). * Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea. * Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
Exclusion criteria
* Female gender * Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator * 3 times repeated measurement of systolic BP outside the range of 90 to 150 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 40 to 100 bpm. In case of documented white coat hypertension the decision for eligibility is left to the investigator. * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters Alanine Transaminase (ALT) (1.25xupper limit of normal (ULN)), Aspartate Transaminase (AST) (1.25xULN) and Total Bilirubin (T-BIL) (1.5xULN) or renal parameters (creatinine 1.25xULN) exceeding the Upper Limit of Normal (ULN) as specified: after 2 times repeated measurements * Any evidence of a concomitant disease assessed as clinically relevant by the investigator * Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * History of relevant orthostatic hypotension, fainting spells, or blackouts * Chronic or relevant acute infections, including positive tests for Hepatitis (Hep) B antigen/ Hep C antibodies, Human immunodeficiency virus (HIV)-1/2 antibodies and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) * Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337 | From 1 day pre-dose till end of trial, up to 40 days | Number of subjects with drug-related adverse events (AEs) after a single dose of BI 3006337 is reported. For drug-related adverse events, medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36. | Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity is reported (AUC0-∞). |
| Maximum Measured Concentration of BI 3006337 in Serum (Cmax) | Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36. | Maximum measured concentration of BI 3006337 in serum (Cmax) is reported. |
| Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax) | Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36. | Time from dosing to the maximum measured concentration of BI 3006337 in serum (tmax) is reported. |
Countries
Belgium, Netherlands
Participant flow
Recruitment details
This was a single-blind, partially randomized within dose groups, placebo-controlled, single rising dose, parallel (sequential) group study in healthy male participants.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo This arm comprises all placebo-treated participants in the trial who were equally distributed across dose groups. Solution for subcutaneous (s.c) injection of placebo was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 19 |
| BI 3006337 0.2 mg Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 5 |
| BI 3006337 0.5 mg Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 6 |
| BI 3006337 1 mg Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 5 |
| BI 3006337 2 mg Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 6 |
| BI 3006337 4 mg Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 5 |
| BI 3006337 8 mg Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 4 |
| BI 3006337 15 mg Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 5 |
| BI 3006337 30 mg Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 4 |
| BI 3006337 50 mg Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 6 |
| BI 3006337 100 mg Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 6 |
| BI 3006337 150 mg Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 9 |
| Total | 80 |
Baseline characteristics
| Characteristic | Placebo | BI 3006337 0.2 mg | BI 3006337 0.5 mg | BI 3006337 1 mg | BI 3006337 2 mg | BI 3006337 4 mg | BI 3006337 8 mg | BI 3006337 15 mg | BI 3006337 30 mg | BI 3006337 50 mg | BI 3006337 100 mg | BI 3006337 150 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 38.8 years STANDARD_DEVIATION 9.7 | 43.0 years STANDARD_DEVIATION 5.4 | 42.7 years STANDARD_DEVIATION 6.2 | 44.8 years STANDARD_DEVIATION 6.9 | 46.3 years STANDARD_DEVIATION 6.5 | 41.6 years STANDARD_DEVIATION 8.8 | 44.8 years STANDARD_DEVIATION 10 | 46.2 years STANDARD_DEVIATION 5.3 | 33.0 years STANDARD_DEVIATION 14.2 | 41.2 years STANDARD_DEVIATION 9 | 39.5 years STANDARD_DEVIATION 13.9 | 37.2 years STANDARD_DEVIATION 12.1 | 41.0 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 5 Participants | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 4 Participants | 5 Participants | 4 Participants | 6 Participants | 6 Participants | 9 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 5 Participants | 5 Participants | 5 Participants | 6 Participants | 5 Participants | 3 Participants | 5 Participants | 4 Participants | 6 Participants | 6 Participants | 9 Participants | 74 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 19 Participants | 5 Participants | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 4 Participants | 5 Participants | 4 Participants | 6 Participants | 6 Participants | 9 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 5 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 5 | 0 / 4 | 0 / 5 | 0 / 4 | 0 / 6 | 0 / 6 | 0 / 9 |
| other Total, other adverse events | 9 / 19 | 3 / 5 | 3 / 6 | 1 / 5 | 1 / 6 | 3 / 5 | 0 / 4 | 0 / 5 | 0 / 4 | 3 / 6 | 4 / 6 | 4 / 9 |
| serious Total, serious adverse events | 0 / 19 | 0 / 5 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 5 | 0 / 4 | 0 / 5 | 0 / 4 | 0 / 6 | 0 / 6 | 0 / 9 |
Outcome results
Primary
Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337
Number of subjects with drug-related adverse events (AEs) after a single dose of BI 3006337 is reported. For drug-related adverse events, medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.
Time frame: From 1 day pre-dose till end of trial, up to 40 days
Population: Treated set (TS): The treated set included all subjects who were entered and treated with any dose of the trial drug or placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337 | 0 Participants |
| BI 3006337 0.2 mg | Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337 | 0 Participants |
| BI 3006337 0.5 mg | Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337 | 1 Participants |
| BI 3006337 1 mg | Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337 | 0 Participants |
| BI 3006337 2 mg | Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337 | 0 Participants |
| BI 3006337 4 mg | Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337 | 2 Participants |
| BI 3006337 8 mg | Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337 | 0 Participants |
| BI 3006337 15 mg | Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337 | 0 Participants |
| BI 3006337 30 mg | Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337 | 0 Participants |
| BI 3006337 50 mg | Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337 | 2 Participants |
| BI 3006337 100 mg | Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337 | 1 Participants |
| BI 3006337 150 mg | Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337 | 1 Participants |
Secondary
Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity is reported (AUC0-∞).
Time frame: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.
Population: Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS even if he contributed only one PK parameter value.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | NA hour*nanogram per milliliter (h‧ng/mL) | — |
| BI 3006337 0.2 mg | Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | NA hour*nanogram per milliliter (h‧ng/mL) | — |
| BI 3006337 0.5 mg | Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 534 hour*nanogram per milliliter (h‧ng/mL) | Geometric Coefficient of Variation 20.7 |
| BI 3006337 1 mg | Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 1200 hour*nanogram per milliliter (h‧ng/mL) | Geometric Coefficient of Variation 52.8 |
| BI 3006337 2 mg | Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 2870 hour*nanogram per milliliter (h‧ng/mL) | Geometric Coefficient of Variation 32.5 |
| BI 3006337 4 mg | Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 3190 hour*nanogram per milliliter (h‧ng/mL) | Geometric Coefficient of Variation 44.9 |
| BI 3006337 8 mg | Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 7920 hour*nanogram per milliliter (h‧ng/mL) | Geometric Coefficient of Variation 26.5 |
| BI 3006337 15 mg | Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 15100 hour*nanogram per milliliter (h‧ng/mL) | Geometric Coefficient of Variation 38.4 |
| BI 3006337 30 mg | Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 40100 hour*nanogram per milliliter (h‧ng/mL) | Geometric Coefficient of Variation 44.2 |
| BI 3006337 50 mg | Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 71300 hour*nanogram per milliliter (h‧ng/mL) | Geometric Coefficient of Variation 37.9 |
| BI 3006337 100 mg | Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 80600 hour*nanogram per milliliter (h‧ng/mL) | Geometric Coefficient of Variation 34.6 |
Secondary
Maximum Measured Concentration of BI 3006337 in Serum (Cmax)
Maximum measured concentration of BI 3006337 in serum (Cmax) is reported.
Time frame: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.
Population: Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS even if he contributed only one PK parameter value to the statistical assessment.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Measured Concentration of BI 3006337 in Serum (Cmax) | 1.78 nanogram per milliliter (ng/ml) | Geometric Coefficient of Variation 43.5 |
| BI 3006337 0.2 mg | Maximum Measured Concentration of BI 3006337 in Serum (Cmax) | 4.38 nanogram per milliliter (ng/ml) | Geometric Coefficient of Variation 75.1 |
| BI 3006337 0.5 mg | Maximum Measured Concentration of BI 3006337 in Serum (Cmax) | 4.70 nanogram per milliliter (ng/ml) | Geometric Coefficient of Variation 34.2 |
| BI 3006337 1 mg | Maximum Measured Concentration of BI 3006337 in Serum (Cmax) | 14.5 nanogram per milliliter (ng/ml) | Geometric Coefficient of Variation 63.7 |
| BI 3006337 2 mg | Maximum Measured Concentration of BI 3006337 in Serum (Cmax) | 37.3 nanogram per milliliter (ng/ml) | Geometric Coefficient of Variation 79.3 |
| BI 3006337 4 mg | Maximum Measured Concentration of BI 3006337 in Serum (Cmax) | 50.8 nanogram per milliliter (ng/ml) | Geometric Coefficient of Variation 18.7 |
| BI 3006337 8 mg | Maximum Measured Concentration of BI 3006337 in Serum (Cmax) | 127 nanogram per milliliter (ng/ml) | Geometric Coefficient of Variation 42.2 |
| BI 3006337 15 mg | Maximum Measured Concentration of BI 3006337 in Serum (Cmax) | 220 nanogram per milliliter (ng/ml) | Geometric Coefficient of Variation 37.5 |
| BI 3006337 30 mg | Maximum Measured Concentration of BI 3006337 in Serum (Cmax) | 642 nanogram per milliliter (ng/ml) | Geometric Coefficient of Variation 49.6 |
| BI 3006337 50 mg | Maximum Measured Concentration of BI 3006337 in Serum (Cmax) | 788 nanogram per milliliter (ng/ml) | Geometric Coefficient of Variation 63 |
| BI 3006337 100 mg | Maximum Measured Concentration of BI 3006337 in Serum (Cmax) | 1290 nanogram per milliliter (ng/ml) | Geometric Coefficient of Variation 54.6 |
Secondary
Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax)
Time from dosing to the maximum measured concentration of BI 3006337 in serum (tmax) is reported.
Time frame: Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36.
Population: Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS even if he contributed only one PK parameter value to the statistical assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax) | 7.0 hour (h) |
| BI 3006337 0.2 mg | Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax) | 15.0 hour (h) |
| BI 3006337 0.5 mg | Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax) | 11.0 hour (h) |
| BI 3006337 1 mg | Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax) | 15.0 hour (h) |
| BI 3006337 2 mg | Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax) | 11.0 hour (h) |
| BI 3006337 4 mg | Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax) | 13.0 hour (h) |
| BI 3006337 8 mg | Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax) | 11.0 hour (h) |
| BI 3006337 15 mg | Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax) | 13.0 hour (h) |
| BI 3006337 30 mg | Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax) | 11.0 hour (h) |
| BI 3006337 50 mg | Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax) | 61.5 hour (h) |
| BI 3006337 100 mg | Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax) | 11.0 hour (h) |