This Study Tests BI 1467335 in Healthy Japanese and Caucasian Men. The Study Tests How Different Doses of BI 1467335 Are Taken up in the Body and How Well They Are Tolerated

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1467335 in Healthy Japanese Male Volunteers With Multiple Oral Doses at the Highest Dose in Caucasian for Comparison (Randomised, Double-blind, Placebo-controlled Trial)

The primary objective of the current study is to investigate the safety and tolerability of BI 1467335 in healthy Japanese male subjects following oral administration of multiple rising doses The Caucasian group will receive higher dose only.

A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 1467335 in healthy Japanese and Caucasian male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 1467335; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Fukuoka, Japan, 812-0025
    • Souseikai Hakata Clinic
  • Tokyo, Sumida-ku, Japan, 130-0004
    • SOUSEIKAI Sumida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion criteria

• Healthy male subjects according to the investigator's assessment, 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

• Japanese ethnicity or Caucasian, according to the following criteria:

  • Japanese; born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan
  • Caucasian
• Age of 20 to 45 years (incl.)
• Body Mass Index (BMI) of 18.5 to 25 kg/m2 (incl.) for Japanese and 18.5 to 29.9 kg/m2 (incl.) for Caucasian
• Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation.

• Male subjects who agree to minimize the risk of female partners becoming pregnant by fulfilling any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:

  • Use of adequate contraception, e.g. any of the following methods plus condom: combined oral contraceptives, intrauterine device
  • Vasectomised (vasectomy at least 1 year prior to enrolment)
  • Surgically sterilised (including hysterectomy) female partner

Exclusion criteria

• Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and 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
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Chronic or relevant acute infections including HIV, viral hepatitis and (or) tuberculosis or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold (or TSPOT) test. Subjects with a positive QuantiFERON TB-Gold (or T-SPOT) test will not participate in the study.
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
• Intake of biologic agents other than current study medication or drugs considered likely to interfere with the safe conduct of the study
• Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
• Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
• Participation in another trial (including bioequivalence trial) with an investigational drug within 90 days or 5 half-lives (whichever is greater) prior to planned administration of trial medication
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
• Inability to refrain from smoking on specified trial days
• Alcohol abuse (consumption of more than 30 g per day)
• Drug abuse or positive drug screening
• Blood donation of more than 200 mL within 30 days prior to administration of trial medication or intended donation during the trial
• Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
• Inability to comply with dietary regimen of trial site
• A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant ECG finding at screening
• A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
• Have received any live bacterial or live viral vaccination in the 12 weeks prior to the date of screening. Subjects must agree not to receive a live bacterial or live viral vaccination during the study and up to 12 months after the last administration of study drug
• Have received Bacille Calmette-Guerin (BCG) vaccination in the 12 months prior to the date of screening. Subjects must agree not to receive BCG vaccination during the study and up to 12 months after the last administration of study drug
• Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
• Signs of cataract at screening by slit lamp test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Duration - 28 days
Experimental: BI 1467335	Drug: BI 1467335; Duration - 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Drug-related Adverse Events	Percentage of subjects with investigator-defined drug-related Adverse Events (AEs) is reported.	From first day of trial medication intake until end of trial, up to 48 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-24	Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose (AUC0-24).	At -0:05 hours (h):minutes (min) before dosing and at 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 23:55 h:min after first dose.
Cmax	Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).	At -0:05 hours (h):minutes (min) before dosing and at 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 23:55 h:min after first dose.
AUC0-24,28	Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of 28th dose (AUC0-24,28).	At 647:55 hours (h):minutes (min) prior to dosing and at 648:15, 648:30, 648:45, 649:00, 649:30, 650:00, 651:00, 652:00, 654:00, 656:00, 658:00, 660:00 and 672:00 h:min after first drug administration.
Cmax,28	Maximum measured concentration of BI 1467335 in plasma following administration of 28th dose (Cmax,28).	At 647:55 hours (h):minutes (min) prior to dosing and at 648:15, 648:30, 648:45, 649:00, 649:30, 650:00, 651:00, 652:00, 654:00, 656:00, 658:00, 660:00 and 672:00 h:min after first drug administration.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2017
• Primary Completion (Actual): December 16, 2017
• Study Completion (Actual): December 16, 2017

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 1386-0007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No