A Study in Healthy Men to Test How Different Doses of BI 3031185 Are Tolerated and How Food Influences the Amount of BI 3031185 in the Blood

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 3031185; Drug: Placebo matching BI 3031185

• Registration Number: NCT06255340
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This trial starts the clinical development of BI 3031185. The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of a range of single doses of BI 3031185 as basis for further development.

The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3031185 tablet formulation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-13
• Study Start: 2024-03-11
• Primary Completion: 2024-08-28
• Study Completion: 2024-08-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

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 without any clinically significant abnormalities
• Age of 18 to 45 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
• 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

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 139 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 89 mmHg, or pulse rate outside the range of 50 to 90 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. This does not include acceptable concomitant conditions that were not assessed as clinically relevant by the investigator (e.g. possible cases of myopia, hyperopia, astigmatism, non-active pollinosis, or mild acne of the skin)
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SRD Part: BI 3031185 dose group 1	BI 3031185	Single rising dose (SRD)
SRD Part: Placebo matching BI 3031185	Placebo matching BI 3031185	-
SRD Part: BI 3031185 dose group 4	BI 3031185	-
SRD Part: BI 3031185 dose group 5	BI 3031185	-
SRD Part: BI 3031185 dose group 2	BI 3031185	-
SRD Part: BI 3031185 dose group 3	BI 3031185	-
SRD Part: BI 3031185 dose group 6	BI 3031185	-
SRD Part: BI 3031185 dose group 7	BI 3031185	-
SRD Part: BI 3031185 dose group 8	BI 3031185	-
FE part: BI 3031185 under fasted (Reference, R) then BI 3031185 under fed (Test,T) conditions	BI 3031185	Food effect (FE)
FE part: BI 3031185 under fed (Test,T) then BI 3031185 under fasted (Reference, R) conditions	BI 3031185	-

Primary Outcome Measures

Name	Time	Method
SRD part: The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator	Up to 22 days
FE part: Area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours (AUC0-24)	Up to 24 hours
FE part: Maximum measured concentration of the analyte in plasma (Cmax)	Up to 8 days

Secondary Outcome Measures

Name	Time	Method
SRD part: Area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours (AUC0-24)	Up to 24 hours
SRD part: Maximum measured concentration of the analyte in plasma (Cmax)	Up to 13 days
FE part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to 8 days

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany