A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated

NCT04958252 | Unknown Phase 1

• 1 other identifier: 1447-0004
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this trial are to investigate safety and tolerability of BI 1569912 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses. Secondary objective is the exploration of pharmacokinetics (PK) of BI 1569912.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Part A and Part B: Percentage of subjects with drug-related adverse events

  up to 27 days

• Part C: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

  up to 3 days

• Part C: Maximum measured concentration of the analyte in plasma (Cmax)

  up to 3 days

Secondary Outcomes (8)

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

  up to 4 days

• Part A: Maximum measured concentration of the analyte in plasma (Cmax)

  up to 4 days

• Part B, after the first dose: Area under the concentration-time curve of the analyte in plasma from 0 to 24 hours (AUC0-24)

  up to 17 days

• Part B, after the first dose: Maximum measured concentration of the analyte in plasma (Cmax)

  up to 17 days

• Part B, after the last dose: Area under the concentration-time curve of the analyte in plasma over the dosing interval τ at steady state (AUCτ,ss)

  up to 17 days

Study Arms (8)

Part A: BI 1569912 low dose

EXPERIMENTAL

Drug: BI 1569912

Part A: BI 1569912 lower medium dose

EXPERIMENTAL

Drug: BI 1569912

Part A: BI 1569912 higher medium dose

EXPERIMENTAL

Drug: BI 1569912

Part A: BI 1569912 high dose

EXPERIMENTAL

Drug: BI 1569912

Part B: BI 1569912 low dose

EXPERIMENTAL

Drug: BI 1569912

Part B: BI 1569912 high dose

EXPERIMENTAL

Drug: BI 1569912

Part C: BI 1569912

EXPERIMENTAL

Drug: BI 1569912

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1569912 DRUG

BI 1569912

Part A: BI 1569912 high dose; Part A: BI 1569912 higher medium dose; Part A: BI 1569912 low dose; Part A: BI 1569912 lower medium dose; Part B: BI 1569912 high dose; Part B: BI 1569912 low dose; Part C: BI 1569912

Placebo DRUG

Placebo

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 medical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
• 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 18 to 45 years (inclusive)
• Body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)
• 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
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate outside the range of 40 to 99 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: NONE
• Masking Details: Part A and Part B of the trial are designed single-blind (to participants). Part C is designed as open-label trial.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A and Part B of the trial is designed as single-blind, partially randomised, and placebo-controlled within parallel dose groups. Part C is designed as a randomised, two-sequence, open-label, two period, two-way cross over trial.

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 12, 2021
• Study Start: August 5, 2021
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)