A Study in Healthy Japanese Men to Test How Well Different Doses of BI 1291583 Are Tolerated

NCT05183347 | Completed Phase 1

• 1 other identifier: 1397-0003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male Japanese subjects following oral administration of single rising doses and 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 65 days

Secondary Outcomes (6)

• SRD: Area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  up to 29 days

• SRD: Maximum measured concentration of BI 1291583 in plasma (Cmax)

  up to 29 days

• MD: After the first dose: Area under the concentration-time curve of BI 1291583 in plasma over a uniform dosing interval τ (AUCτ,1)

  up to 24 hours

• MD: After the first dose: Maximum measured concentration of BI 1291583 in plasma (Cmax,1)

  up to 24 hours

• MD: After the last dose: Area under the concentration-time curve of BI 1291583 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)

  at day 28

Study Arms (5)

SRD: Dose Group 1

EXPERIMENTAL

SRD: single-rising dose

Drug: BI 1291583

SRD: Dose Group 2

EXPERIMENTAL

SRD: single-rising dose

Drug: BI 1291583

SRD: Dose Group 3

EXPERIMENTAL

SRD: single-rising dose

Drug: BI 1291583

MD: Dose Group 4

EXPERIMENTAL

MD: multiple doses

Drug: BI 1291583

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1291583 DRUG

BI 1291583

Also known as: Verducatib

MD: Dose Group 4; SRD: Dose Group 1; SRD: Dose Group 2; SRD: Dose Group 3

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• 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 at screening visit
• 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
• Age of 20 to 45 years (inclusive) at screening visit
• BMI of 18.5 to 25.0 kilograms divided by height in meters squared (kg/m2) (inclusive) at screening visit
• Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
• Subjects who agree to minimize the risk of making their partner pregnant by fulfilling any of the following criteria starting from the first administration of trial medication until 90 days after last administration of trial medication
• Use of adequate contraception, any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration
• Vasectomized (vasectomy at least 1 year prior to enrolment)
• Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner

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 at screening visit
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre 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) at screening visit
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening visit
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
• Chronic or relevant acute infections including viral hepatitis human immunodeficiency virus (HIV) and/or syphilis
• History of cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
• Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT / QTc interval prolongation \[QT: Time between start of the Q-wave and the end of the T-wave in an electrocardiogram, QTc: QT interval corrected for heart rate using the method of Fridericia (QTcF) or Bazett (QTcB)\]

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 10, 2022
• Study Start: February 4, 2022
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)