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Completed

NCT Number: NCT05633862

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

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College Hospital

Beijing, 100032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BI 1015550

Drug

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

Other names: Nerandomilast, JASCAYD®

Primary outcomes

  1. 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.

    Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

  2. 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.

    Maximum measured concentration of BI 1015550 in plasma (Cmax).

Secondary outcomes

  1. Number of Subjects With Any Treatment-emergent Adverse Event (AE)

    Time frame: Up to 7 days.

    Number of subjects with any treatment-emergent adverse event (AE).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Pharmacokinetics, Safety and Tolerability of Doses of BI 1015550 in Healthy Chinese Male and Female Subjects (Open-label, Parallel Group Design)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2022
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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