Clinical trial NCT06139341: A Study in Healthy Japanese Men to Test How Well Different Doses of BI 765845 Are Tolerated
Official title: Safety, Tolerability, and Pharmacokinetics of Single Rising Intravenous Doses of BI 765845 in Healthy Male Japanese Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 765845 in healthy male Japanese subjects following intravenous administration of single rising doses.


Eligibility criteria: 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 at screening visit
* 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) at screening visit
* BMI of 18.5 to 24.9 kg/m2 (inclusive) at screening visit
* Signed and dated written informed consent in accordance with ICH-Good Clinical Practice (GCP) and local legislation prior to admission to the trial
* Subjects who agree to minimise the risk of making their partner pregnant by fulfilling any of the following criteria starting from the start of infusion of trial medication until 90 days after end of infusion 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
  * Female partner is postmenopausal, defined as no menses for 1 year without an alternative medical cause

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator at screening visit
* Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 50 to 90 bpm at screening visit
* 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 (including any history of cardiovascular diseases such as atherosclerosis, previous myocardial infarction or angina pectoris)
* 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 history of stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts

Primary outcomes:
measure: Percentage of subjects with treatment-emergent adverse event assessed as drug-related by the investigator
timeFrame: Up to 73 days
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: Up to 71 days
measure: Maximum measured concentration of the analyte in serum (Cmax)
timeFrame: Up to 71 days
Other outcomes:
Locations:
city: Tokyo, Shinjuku-ku
country: Japan
facility: Clinical Research Hospital Tokyo
Study officials:
References: