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

A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3031185 Administered as Tablet to Healthy Male Subjects, and a Randomised, Open-label, Single-dose, Two-way Cross-over Relative Bioavailability Comparison of BI 3031185 as Tablet With and Without Food in Healthy Male Subjects

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 3031185; Drug: Placebo matching BI 3031185

• Study Type: Interventional
• Enrollment (Estimated): 76
• 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

• Germany
  • Biberach, Germany, 88397
    • Recruiting
    • Humanpharmakologisches Zentrum Biberach
    • Contact: Boehringer Ingelheim; Phone Number: 08007234742; Email: deutschland@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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SRD Part: BI 3031185 dose group 1; Single rising dose (SRD)	Drug: BI 3031185; BI 3031185
Experimental: SRD Part: BI 3031185 dose group 2	Drug: BI 3031185; BI 3031185
Experimental: SRD Part: BI 3031185 dose group 3	Drug: BI 3031185; BI 3031185
Experimental: SRD Part: BI 3031185 dose group 4	Drug: BI 3031185; BI 3031185
Experimental: SRD Part: BI 3031185 dose group 5	Drug: BI 3031185; BI 3031185
Experimental: SRD Part: BI 3031185 dose group 6	Drug: BI 3031185; BI 3031185
Experimental: SRD Part: BI 3031185 dose group 7	Drug: BI 3031185; BI 3031185
Experimental: SRD Part: BI 3031185 dose group 8	Drug: BI 3031185; BI 3031185
Placebo Comparator: SRD Part: Placebo matching BI 3031185	Drug: Placebo matching BI 3031185; Placebo
Experimental: FE part: BI 3031185 under fasted (Reference, R) then BI 3031185 under fed (Test,T) conditions; Food effect (FE)	Drug: BI 3031185; BI 3031185
Experimental: FE part: BI 3031185 under fed (Test,T) then BI 3031185 under fasted (Reference, R) conditions	Drug: BI 3031185; BI 3031185

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2024
• Primary Completion (Estimated): July 9, 2024
• Study Completion (Estimated): July 9, 2024

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1516-0001

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