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

A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 1815368 Administered as Oral Solution to Healthy Male Subjects (SRD Part), and a Randomised, Open-label, Single-dose, Three-way Cross-over Part Investigating Relative Bioavailability of BI 1815368 as Tablet Versus Oral Solution and Tablet With and Without Food in Healthy Male Subjects (BA Part)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BI 1815368 formulation 1; Drug: BI 1815368 formulation 2

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Biberach, Germany, 88397
    • Humanpharmakologisches Zentrum Biberach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SRD part: BI 1815368	Drug: BI 1815368 formulation 1; BI 1815368 formulation 1
Placebo Comparator: SRD part: Placebo	Drug: Placebo; Placebo
Experimental: BA part: T1-R-T2; R: BI 1815368 formulation 1, fasted condition T1: BI 1815368 formulation 2, fasted condition T2: BI 1815368 formulation 2, fed condition	Drug: BI 1815368 formulation 1; BI 1815368 formulation 1; Drug: BI 1815368 formulation 2; BI 1815368 formulation 2
Experimental: BA part: R-T2-T1	Drug: BI 1815368 formulation 1; BI 1815368 formulation 1; Drug: BI 1815368 formulation 2; BI 1815368 formulation 2
Experimental: BA part: T2-T1-R	Drug: BI 1815368 formulation 1; BI 1815368 formulation 1; Drug: BI 1815368 formulation 2; BI 1815368 formulation 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Actual): October 18, 2022
• Study Completion (Actual): October 18, 2022

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1485-0001; 2021-006856-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No