Clinical trial 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
Official 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 Randomised Within Dose Groups, Placebo-controlled, Parallel-group Design)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-07-12
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Part A and Part B of the trial is designed as single-blind, partially randomised, and placebo-controlled within parallel dose groups.

Part C is designed as a randomised, two-sequence, open-label, two period, two-way cross over trial.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Part A and Part B: Percentage of subjects with drug-related adverse events
timeFrame: up to 27 days
measure: Part C: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: up to 3 days
measure: Part C: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: up to 3 days
Secondary outcomes:
measure: Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: up to 4 days
measure: Part A: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: up to 4 days
measure: Part B, after the first dose: Area under the concentration-time curve of the analyte in plasma from 0 to 24 hours (AUC0-24)
timeFrame: up to 17 days
measure: Part B, after the first dose: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: up to 17 days
measure: Part B, after the last dose: Area under the concentration-time curve of the analyte in plasma over the dosing interval τ at steady state (AUCτ,ss)
timeFrame: up to 17 days
measure: Part B, after the last dose: Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)
timeFrame: up to 17 days
measure: Part C: Percentage of subjects with drug-related adverse events
timeFrame: up to 3 days
measure: Part C: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: up to 3 days
Other outcomes:
Locations:
city: Tokyo, Sumida-ku
country: Japan
facility: SOUSEIKAI Sumida Hospital
Study officials:
References: