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

NCT06255340 | Completed Phase 1

• 1 other identifier: 1516-0001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (11)

SRD Part: BI 3031185 dose group 1

EXPERIMENTAL

Single rising dose (SRD)

Drug: BI 3031185

SRD Part: BI 3031185 dose group 2

EXPERIMENTAL

Drug: BI 3031185

SRD Part: BI 3031185 dose group 3

EXPERIMENTAL

Drug: BI 3031185

SRD Part: BI 3031185 dose group 4

EXPERIMENTAL

Drug: BI 3031185

SRD Part: BI 3031185 dose group 5

EXPERIMENTAL

Drug: BI 3031185

SRD Part: BI 3031185 dose group 6

EXPERIMENTAL

Drug: BI 3031185

SRD Part: BI 3031185 dose group 7

EXPERIMENTAL

Drug: BI 3031185

SRD Part: BI 3031185 dose group 8

EXPERIMENTAL

Drug: BI 3031185

SRD Part: Placebo matching BI 3031185

PLACEBO COMPARATOR

Drug: Placebo matching BI 3031185

FE part: BI 3031185 under fasted (Reference, R) then BI 3031185 under fed (Test,T) conditions

EXPERIMENTAL

Food effect (FE)

Drug: BI 3031185

FE part: BI 3031185 under fed (Test,T) then BI 3031185 under fasted (Reference, R) conditions

EXPERIMENTAL

Drug: BI 3031185

Interventions

BI 3031185 DRUG

BI 3031185

FE part: BI 3031185 under fasted (Reference, R) then BI 3031185 under fed (Test,T) conditions; FE part: BI 3031185 under fed (Test,T) then BI 3031185 under fasted (Reference, R) conditions; SRD Part: BI 3031185 dose group 1; SRD Part: BI 3031185 dose group 2; SRD Part: BI 3031185 dose group 3; SRD Part: BI 3031185 dose group 4; SRD Part: BI 3031185 dose group 5; SRD Part: BI 3031185 dose group 6; SRD Part: BI 3031185 dose group 7; SRD Part: BI 3031185 dose group 8

Placebo matching BI 3031185 DRUG

Placebo

SRD Part: Placebo matching BI 3031185

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: FE part of the trial is designed as open-label. SRD part is designed as blinded to subjects.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The food effect (FE) part of the trial is designed as a randomised, two-sequence, open-label, two period, two-way cross-over trial. The single rising dose (SRD) part is designed as blinded to subjects, randomised, and placebo-controlled within parallel dose groups.

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: March 11, 2024
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)