Healthy
Conditions
Brief summary
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.
Interventions
DRUGBI 1015550
A single film-coated tablet BI 1015550 taken orally after an overnight fast of at least 10 hours.
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours following drug administration. | Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). |
| Maximum Measured Concentration of BI 1015550 in Plasma (Cmax) | Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours following drug administration. | Maximum measured concentration of BI 1015550 in plasma (Cmax). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Treatment-emergent Adverse Event (AE) | Up to 7 days. | Number of subjects with any treatment-emergent adverse event (AE). |
Countries
China
Participant flow
Recruitment details
This was a non-randomised, uncontrolled, open label, single-dose, parallel-group design trial.
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 |
|---|---|
| BI 1015550 9 mg A single film-coated tablet of 9 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours. | 12 |
| BI 1015550 18 mg A single film-coated tablet of 18 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Total | BI 1015550 9 mg | BI 1015550 18 mg |
|---|---|---|---|
| Age, Continuous | 33.3 years STANDARD_DEVIATION 5 | 36.7 years STANDARD_DEVIATION 4.9 | 29.8 years STANDARD_DEVIATION 1.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 12 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian Indian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Chinese | 24 Participants | 12 Participants | 12 Participants |
| Race/Ethnicity, Customized Japanese | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Korean | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Southeast Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Taiwanese | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Male | 13 Participants | 6 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 2 / 12 | 6 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Time frame: Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours following drug administration.
Population: Pharmacokinetic parameter analysis set (PKS): all subjects who were treated with at least one dose of trial and who provided at least one pharmacokinetic (PK) endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 1015550 9 mg | Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 1780 Nanomol*Hour/Liter | Geometric Coefficient of Variation 19.1 |
| BI 1015550 18 mg | Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 3680 Nanomol*Hour/Liter | Geometric Coefficient of Variation 32.6 |
Primary
Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)
Maximum measured concentration of BI 1015550 in plasma (Cmax).
Time frame: Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours following drug administration.
Population: Pharmacokinetic parameter analysis set (PKS): all subjects who were treated with at least one dose of trial and who provided at least one pharmacokinetic (PK) endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 1015550 9 mg | Maximum Measured Concentration of BI 1015550 in Plasma (Cmax) | 325 Nanomol/Liter | Geometric Coefficient of Variation 30.3 |
| BI 1015550 18 mg | Maximum Measured Concentration of BI 1015550 in Plasma (Cmax) | 591 Nanomol/Liter | Geometric Coefficient of Variation 39 |
Secondary
Number of Subjects With Any Treatment-emergent Adverse Event (AE)
Number of subjects with any treatment-emergent adverse event (AE).
Time frame: Up to 7 days.
Population: Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BI 1015550 9 mg | Number of Subjects With Any Treatment-emergent Adverse Event (AE) | 2 Participants |
| BI 1015550 18 mg | Number of Subjects With Any Treatment-emergent Adverse Event (AE) | 6 Participants |