A Study in Healthy Men to Test How Well Different Doses of BI 1819479 Are Tolerated

NCT05469646 | Completed Phase 1

• 1 other identifier: 1462-0003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1819479 in healthy male Japanese subjects receiving single rising doses (SRD) in order to provide the basis for a clinical development of BI 1819479 in Japan.

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 64 Days

Secondary Outcomes (2)

• Area under the concentration-time curve of BI 1819479 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  Up to 31 Days

• Maximum measured concentration of BI 1819479 in plasma (Cmax)

  Up to 31 Days

Study Arms (4)

Dose Group 1: BI 1819479 (Low dose)

EXPERIMENTAL

Drug: BI 1819479

Dose Group 2: BI 1819479 (Middle dose)

EXPERIMENTAL

Drug: BI 1819479

Dose Group 3: BI 1819479 (High Dose)

EXPERIMENTAL

Drug: BI 1819479

Placebo

PLACEBO COMPARATOR

Drug: Matching placebo

Interventions

BI 1819479 DRUG

BI 1819479

Dose Group 1: BI 1819479 (Low dose); Dose Group 2: BI 1819479 (Middle dose); Dose Group 3: BI 1819479 (High Dose)

Matching placebo DRUG

Matching 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 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 18 to 45 years (inclusive) at screening visit
• Body mass index (BMI) of 18.5 to 24.9 kg/m2 (inclusive) at screening visit
• 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
• Subjects who agree to minimise the risk of making their partner pregnant by fulfilling any of the following criteria starting from the admission to trial site until 90 days after 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.
• Female partner is postmenopausal, defined as no menses for 1 year without an alternative medical cause.

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 BP outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic BP outside the range of 40 to 90 mmHg, or PR outside the range of 40 to 99 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
• 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 20, 2022
• First Posted: July 22, 2022
• Study Start: August 3, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 27, 2022
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)