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

NCT05857878 | Completed Phase 1

• 3 other identifiers: 1485-00022023-503815-13-002022-002278-96
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of patients treated who experience treatment-emergent adverse event assessed as drug-related by the investigator

  Up to 29 days

Secondary Outcomes (3)

• 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

Study Arms (7)

Placebo

PLACEBO COMPARATOR

Drug: Matching placebo

Dose Group 1

EXPERIMENTAL

Drug: BI 1815368

Dose Group 2

EXPERIMENTAL

Drug: BI 1815368

Dose Group 3

EXPERIMENTAL

Drug: BI 1815368

Dose Group 4

EXPERIMENTAL

Drug: BI 1815368

Dose Group 5

EXPERIMENTAL

Drug: BI 1815368

Dose Group 6

EXPERIMENTAL

Drug: BI 1815368

Interventions

BI 1815368 DRUG

BI 1815368

Dose Group 1; Dose Group 2; Dose Group 3; Dose Group 4; Dose Group 5; Dose Group 6

Matching placebo DRUG

Matching placebo

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 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.
• 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.

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 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 15, 2023
• Study Start: June 23, 2023
• Primary Completion: June 6, 2024
• Study Completion: June 6, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)