A Study in Healthy Men to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body With or Without Food

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1815368 formulation 1; Drug: Placebo; Drug: BI 1815368 formulation 2

• Registration Number: NCT05337592
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Single-rising dose (SRD) part The main objectives of the SRD part of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1815368 in healthy male subjects following oral administration of single rising doses.

Bioavailability (BA) part The main objective of the BA part is to investigate the relative bioavailability of a tablet formulation versus oral solution and to assess the influence of food on the relative bioavailability of the tablet formulation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-20
• Study Start: 2022-06-14
• Status Verified: 2022-10
• Primary Completion: 2022-10-18
• Study Completion: 2022-10-18
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

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
• 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 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BA part: T2-T1-R	BI 1815368 formulation 2	-
SRD part: BI 1815368	BI 1815368 formulation 1	-
SRD part: Placebo	Placebo	-
BA part: T1-R-T2	BI 1815368 formulation 1	R: BI 1815368 formulation 1, fasted condition T1: BI 1815368 formulation 2, fasted condition T2: BI 1815368 formulation 2, fed condition
BA part: T1-R-T2	BI 1815368 formulation 2	R: BI 1815368 formulation 1, fasted condition T1: BI 1815368 formulation 2, fasted condition T2: BI 1815368 formulation 2, fed condition
BA part: R-T2-T1	BI 1815368 formulation 1	-
BA part: R-T2-T1	BI 1815368 formulation 2	-
BA part: T2-T1-R	BI 1815368 formulation 1	-

Primary Outcome Measures

Name	Time	Method
SRD part: Occurrence of any treatment-emergent adverse event	Up to Day 14
BA part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	Up to Day 5
BA part: Maximum measured concentration of BI 1815368 in plasma (Cmax)	Up to Day 5

Secondary Outcome Measures

Name	Time	Method
SRD part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	up to Day 6
SRD part: Maximum measured concentration of BI 1815368 in plasma (Cmax)	up to Day 6
BA part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to Day 5

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany