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OpenTrials
Completed

NCT Number: NCT06494774

A Study to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body of Healthy Japanese Men

The main objectives of this trial are to investigate safety, tolerability. pharmacokinetics (PK), and pharmacodynamics of BI 1815368 in healthy Japanese male subjects following administration of single rising doses or multiple doses.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SOUSEIKAI Sumida Hospital

Tokyo, Sumida-ku, 130-0004, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male 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 45 years (inclusive)
  • Body mass index (BMI) of 18.5 to 25 kg/m2 (inclusive)
  • Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
  • Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese

Exclusion criteria

  • 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 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate outside the range of 40 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
  • History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Treatment and study plan

BI 1815368

Drug

BI 1815368

Placebo matching BI 1815368

Drug

Placebo matching BI 1815368

Primary outcomes

  1. Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

    Time frame: Up to 26 days

Secondary outcomes

  1. SRD part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Time frame: Up to 6 days

    Single-rising dose (SRD)

  2. SRD part: Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: Up to 6 days

    Single-rising dose (SRD)

  3. MD part: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)

    Time frame: Up to 19 days

    Multiple dose (MD)

  4. MD part: Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)

    Time frame: Up to 19 days

    Multiple dose (MD)

  5. MD part: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)

    Time frame: Up to 19 days

    Multiple dose (MD)

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses and Multiple Oral Doses Over 10 Days of BI 1815368 in Japanese Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2024
Registry last updated
Jan 22, 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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