A Study in Healthy Chinese People to Test How Different Doses of BI 1015550 Are Taken up in the Body

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-13

Study Completion Date

2023-03-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

BI 1015550

Intervention Type DRUG

A single film-coated tablet BI 1015550 taken orally after an overnight fast of at least 10 hours.

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.

Group Type EXPERIMENTAL

BI 1015550

Intervention Type DRUG

A single film-coated tablet BI 1015550 taken orally after an overnight fast of at least 10 hours.

Interventions

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BI 1015550

A single film-coated tablet BI 1015550 taken orally after an overnight fast of at least 10 hours.

Intervention Type DRUG

Other Intervention Names

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Nerandomilast JASCAYD®

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes