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Completed

NCT Number: NCT04958252

A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated

The main objectives of this trial are to investigate safety and tolerability of BI 1569912 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.

Secondary objective is the exploration of pharmacokinetics (PK) of BI 1569912.

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Key information

Conditions

Healthy

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 medical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
  • 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
  • Age of 18 to 45 years (inclusive)
  • Body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)
  • Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
  • Subjects who agree to minimize the risk of making their partner pregnant by fulfilling any of the following criteria starting from the first administration of trial medication until 90 days after last administration of trial medication
  • Use of adequate contraception, any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration.
  • Vasectomized (vasectomy at least 1 year prior to enrolment)
  • Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner

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 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate outside the range of 40 to 99 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 1569912

Drug

BI 1569912

Placebo

Drug

Placebo

Primary outcomes

  1. SRD Part - Number of Subjects With Drug-related Adverse Events

    Time frame: From drug administration plus 48 hours (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours.

    Number of subjects in the single-rising dose (SRD) part with drug-related adverse events (AEs) is reported.

  2. MD Part - Number of Subjects With Drug-related Adverse Events

    Time frame: From first drug administration until last administration of study drug plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days.

    Number of subjects in the multiple dose (MD) part with drug-related adverse events is reported.

  3. Evening PK Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

    Time frame: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.

    Evening pharmacokinetics (PK) part - area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.

    Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale.

  4. Evening PK Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)

    Time frame: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.

    Evening pharmacokinetics (PK) part - maximum measured concentration of BI 1569912 in plasma (Cmax) is reported.

    Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale.

Secondary outcomes

  1. Evening PK Part - Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

    Time frame: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.

    Evening pharmacokinetics (PK) part - area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.

    Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale.

  2. SRD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

    Time frame: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration.

    Single-rising dose (SRD) part - area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.

  3. SRD Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)

    Time frame: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration.

    Single-rising dose (SRD) part - maximum measured concentration of BI 1569912 in plasma (Cmax) is reported.

  4. MD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma From 0 to 24 h (AUC0-24) After the First Dose

    Time frame: Within 3 h prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration.

    Multiple dose (MD) part - area under the concentration-time curve of BI 1569912 in plasma from 0 to 24 hours (h) (AUC0-24) after the first dose is reported. AUC0-24 was calculated by extrapolation

  5. MD Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax) After the First Dose

    Time frame: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration.

    Multiple dose (MD) part - maximum measured concentration of BI 1569912 in plasma (Cmax) after the first dose is reported.

  6. MD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Dosing Interval τ at Steady State (AUCτ,ss) After the Last Dose

    Time frame: One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration.

    Multiple dose (MD) part - area under the concentration-time curve of BI 1569912 in plasma over the dosing interval τ at steady state (AUCτ,ss) after the last dose is reported. The dosing interval τ is 24 hours (h).

  7. MD Part - Maximum Measured Concentration of BI 1569912 in Plasma at Steady State (Cmax,ss) After the Last Dose

    Time frame: One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration.

    Multiple dose (MD) part - maximum measured concentration of BI 1569912 in plasma at steady state (Cmax,ss) after the last dose is reported.

  8. Evening PK Part - Number of Subjects With Drug-related Adverse Events

    Time frame: From drug administration plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours.

    Number of subjects in the evening pharmacokinetics (PK) part with drug-related adverse events is reported.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1569912 in Healthy Male Japanese Subjects (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel-group Design)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2021
Registry last updated
May 22, 2026

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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