A Study to Test How Different Doses of BI 1815368 Are Tolerated and How BI 1815368 is Taken up in the Body of Healthy Japanese Men

NCT06494774 | Completed Phase 1

• 1 other identifier: 1485-0005
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this trial are to investigate safety, tolerability. pharmacokinetics (PK), and pharmacodynamics of BI 1815368 in healthy Japanese male subjects following administration of single rising doses or multiple doses.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

  Up to 26 days

Secondary Outcomes (5)

• SRD part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  Up to 6 days

• SRD part: Maximum measured concentration of the analyte in plasma (Cmax)

  Up to 6 days

• MD part: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)

  Up to 19 days

• MD part: Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)

  Up to 19 days

• MD part: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)

  Up to 19 days

Study Arms (4)

SRD part: low dose

EXPERIMENTAL

Single-rising dose (SRD)

Drug: BI 1815368

SRD part: medium dose followed by MD part

EXPERIMENTAL

Single-rising dose (SRD) Multiple dose (MD)

Drug: BI 1815368

SRD part: high dose

EXPERIMENTAL

Drug: BI 1815368

Placebo

PLACEBO COMPARATOR

Drug: Placebo matching BI 1815368

Interventions

BI 1815368 DRUG

BI 1815368

SRD part: high dose; SRD part: low dose; SRD part: medium dose followed by MD part

Placebo matching BI 1815368 DRUG

Placebo matching BI 1815368

Placebo

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
• Age of 18 to 45 years (inclusive)
• Body mass index (BMI) of 18.5 to 25 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
• Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who are Japanese

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 40 to 90 mmHg, or pulse rate outside the range of 40 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)

SOUSEIKAI Sumida Hospital

Tokyo, Sumida-ku, 130-0004, Japan

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: July 3, 2024
• First Posted: July 10, 2024
• Study Start: August 19, 2024
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)