Phase 1
N=24
A Study in Healthy Chinese People to Test How Different Doses of BI 1015550 Are Taken up in the Body
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05633862 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) — 1780; 3680 Nanomol*Hour/Liter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 1015550 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
1780; 3680 | — |
| PRIMARY Maximum Measured Concentration of BI 1015550 in Plasma (Cmax) |
325; 591 | — |
| SECONDARY Number of Subjects With Any Treatment-emergent Adverse Event (AE) |
2; 6 | — |
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.
Eligibility Criteria
Inclusion criteria
Chinese subjects will only be included in the trial if they meet the following criteria:
- 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
- Age of 18 to 55 years (inclusive)
- Body mass index (BMI) of 18.5 to 28.0 kg/m² (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- 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:
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- 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)
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- 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)
- History of relevant orthostatic hypotension, fainting spells, or blackouts. Further exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT05633862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.