RecruitingPhase 1NCT06916702

A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men and Women

Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 3031185 in Healthy Male and Female Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Sponsor

Boehringer Ingelheim

Enrollment

100 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy

Summary

Part A: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male subjects following administration of multiple rising doses. Part B: The main objectives of Part B of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3031185 in healthy male subjects and female subjects of non-childbearing potential following oral administration of multiple doses of BI 3031185.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria7

Part A: 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 Part B: Healthy male and female (women of non-childbearing potential) subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
Part A: Age of 18 to 50 years (inclusive) Part B: Age of 18 to 55 years (inclusive)
Part A: Body Mass Index (BMI) of 20.0 to 29.9 kg/m (inclusive) and body weight of at least 60 kg
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
Part B: For female trial participants: Female trial participants who meet any of the following criteria (women of non-childbearing potential):
Permanently sterilised (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
Postmenopausal, defined as no menses for at least 1 year without an alternative medical cause. In questionable cases a blood sample with FSH above 40 U/L and estradiol below 30 ng/L at screening is confirmatory

Exclusion Criteria4

Any finding in the medical examination (including BP, Pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement at screening of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 50 to 89 mmHg, or pulse rate outside the range of 50 to 90 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

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