Clinical trial NCT06310005: A Study in Healthy Japanese Men to Test How Well Different Doses of BI 3006337 Are Tolerated
Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Subcutaneous Doses and Multiple Subcutaneous Doses Over 6 Weeks of BI 3006337 in Healthy Male Japanese Subjects (Single-blind, Randomised Within Dose Groups, Placebo-controlled, Parallel Group Design)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-03-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Trial consists of a single-rising dose (SRD) and multiple dose (MD) part. In SRD part, the groups will be dosed consecutively in ascending order. The decision proceeding to MD part will be based upon safety and tolerability of all the preceding dose groups in SRD part. Within each dose group, patients will be randomized to either BI 3006337 or placebo.
Primary purpose: TREATMENT

Brief summary: The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BI 3006337 in healthy male subjects following s.c. administration of single rising doses and multiple doses over 6 weeks.


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
* 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 in accordance with International Conference of Harmonization - Good Clinical Practice (ICH-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 injection of trial medication until 30 days after end of injection 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
* 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 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
* Clinically relevant 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: SRD + MD part: Percentage of patients with any treatment-emergent adverse event assessed as drug-related by the investigator
timeFrame: Up to 74 days.
Secondary outcomes:
measure: SRD part: Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf)
timeFrame: Up to 40 days.
measure: SRD part: Maximum measured concentration of BI 3006337 in serum (Cmax)
timeFrame: Up to 40 days.
measure: MD part: Area under the concentration-time curve of BI 3006337 in serum over the dosing interval tau at steady state (AUCtau, ss) after the last dose in Week 6
timeFrame: Up to Week 6.
measure: MD part: Maximum measured concentration of BI 3006337 in serum at steady state (Cmax, ss) after the last dose in Week 6
timeFrame: Up to Week 6.
Other outcomes:
Locations:
city: Tokyo, Shinjuku-ku
country: Japan
facility: Clinical Research Hospital Tokyo
Study officials:
References: