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

NCT03159455 | Completed Phase 1 Results

• 1 other identifier: 1386-0007
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  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

  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

  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.

Study Arms (2)

BI 1467335

EXPERIMENTAL

Drug: BI 1467335

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1467335 DRUG

Duration - 28 days

BI 1467335

Placebo DRUG

Duration - 28 days

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

Souseikai Hakata Clinic

Fukuoka, Fukuoka, 812-0025, Japan

Location

SOUSEIKAI Sumida Hospital

Tokyo, Sumida-ku, 130-0004, Japan

Location

Related Links

• Related Info

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 18, 2017
• Study Start: June 7, 2017
• Primary Completion: December 16, 2017
• Study Completion: December 16, 2017
• Last Updated: June 4, 2021
• Results First Posted: June 4, 2021

Record last verified: 2021-05

Locations

JP (2)