Pharmacokinetics, Safety and Tolerability of Doses of BI 1015550 in Healthy Chinese Male and Female Subjects (Open-label, Parallel Group Design)
The main objectives of this trial are to investigate pharmacokinetics, safety and tolerability of BI 1015550 in Chinese healthy male and female subjects following administration of single doses.
Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers
Inclusion criteria
Chinese subjects will only be included in the trial if they meet the following criteria:
1. Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.5 to 28.0 kg/m² (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
5. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. Of note, oral hormonal contraceptives are not considered a highly effective method due to potential drug-drug interactions. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the patient information.
Exclusion criteria
Subjects will not be allowed to participate, if any of the following general criteria apply:
1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders (including but not limited to major depressive disorder or any history of suicidal ideation or behaviour)
8. History of relevant orthostatic hypotension, fainting spells, or blackouts. Further exclusion criteria apply.
Participant flow
| Milestone | BI 1015550 9 mg | BI 1015550 18 mg |
|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
Outcome results
- Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (Primary), Geometric mean, Nanomol*Hour/Liter: BI 1015550 9 mg 1780 +/- 19.1; BI 1015550 18 mg 3680 +/- 32.6
- Maximum Measured Concentration of BI 1015550 in Plasma (Cmax) (Primary), Geometric mean, Nanomol/Liter: BI 1015550 9 mg 325 +/- 30.3; BI 1015550 18 mg 591 +/- 39.0
- Number of Subjects With Any Treatment-emergent Adverse Event (AE) (Secondary), Count of participants, Participants: BI 1015550 9 mg 2; BI 1015550 18 mg 6
Adverse events
Time frame: Adverse events: Up to 7 days. All-cause mortality: Up to 14 days.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| BI 1015550 9 mg | 0/12 (0.0%) | 0/12 (0.0%) | 2/12 (16.7%) |
| BI 1015550 18 mg | 0/12 (0.0%) | 0/12 (0.0%) | 6/12 (50.0%) |
Other adverse events by term
| Term | Organ system | BI 1015550 9 mg | BI 1015550 18 mg |
|---|
| Alanine aminotransferase increased | Investigations | 0/12 | 2/12 |
| Aspartate aminotransferase increased | Investigations | 0/12 | 1/12 |
| Basophil count increased | Investigations | 0/12 | 1/12 |
| C-reactive protein increased | Investigations | 1/12 | 0/12 |
| Eosinophil count increased | Investigations | 0/12 | 1/12 |
| Gamma-glutamyltransferase increased | Investigations | 0/12 | 1/12 |
| Neutrophil count increased | Investigations | 0/12 | 1/12 |
| Urinary occult blood positive | Investigations | 1/12 | 0/12 |
| White blood cell count increased | Investigations | 0/12 | 1/12 |
| White blood cells urine positive | Investigations | 0/12 | 2/12 |
| Hyponatraemia | Metabolism and nutrition disorders | 0/12 | 1/12 |