A Study to Test How Well Different Doses of BI 1815368 Are Tolerated by Healthy Men

Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1815368 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

This trial aims to investigate safety, tolerability, and pharmacokinetics following multiple rising doses of BI 1815368 in healthy male subjects.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Matching placebo; Drug: BI 1815368

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Recruiting
    • SGS Life Science Services - Clinical Research
    • Contact: Boehringer Ingelheim; Phone Number: 080049616; Email: belgique@bitrialsupport.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

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 55 years (inclusive).
• Body mass index (BMI) of 19 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(s) 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: Parallel Assignment
• Masking: Single

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Matching placebo; Matching placebo; Other Names: Placebo
Experimental: Dose Group 1	Drug: BI 1815368; BI 1815368
Experimental: Dose Group 2	Drug: BI 1815368; BI 1815368
Experimental: Dose Group 3	Drug: BI 1815368; BI 1815368
Experimental: Dose Group 4	Drug: BI 1815368; BI 1815368
Experimental: Dose Group 5	Drug: BI 1815368; BI 1815368
Experimental: Dose Group 6	Drug: BI 1815368; BI 1815368

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients treated who experience treatment-emergent adverse event assessed as drug-related by the investigator	Up to 29 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve of BI 1815368 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)	Up to 16 days
Minimum concentration of BI 1815368 in plasma at steady state over a uniform dosing interval τ (Cmin,ss)	Up to 16 days
Maximum measured concentration of BI 1815368 in plasma at steady state over a uniform dosing interval τ (Cmax,ss)	Up to 16 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Estimated): June 14, 2024
• Study Completion (Estimated): June 14, 2024

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1485-0002; 2023-503815-13-00 (Registry Identifier: CTIS)

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