Skip to main content
MedPathMedPath Home
Clinical Trials/JPRN-jRCT2080225328
JPRN-jRCT2080225328
Suspended
Phase 1

Safety, tolerability and pharmacokinetics of single rising oral doses of BI 894416 versus placebo in healthy male Japanese subjects (single-blind, randomized, placebo-controlled within dose group)

ippon Boehringer Ingelheim Co., Ltd.0 sites24 target enrollmentAugust 21, 2020
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ippon Boehringer Ingelheim Co., Ltd.
Enrollment
24
Status
Suspended
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 21, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
ippon Boehringer Ingelheim Co., Ltd.

Eligibility Criteria

Inclusion Criteria

  • •1\.Healthy male subjects according to the assessment of the investigator, as based on a complete medical history, including a medical examination, vital signs (BP, PR), 12\-lead ECG, and clinical laboratory tests
  • •2\.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
  • •3\.Age of 20 to 45 years (inclusive) at screening
  • •4\.BMI of 18\.5 to 25\.0 kg/m2 (inclusive) at screening
  • •5\.Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation
  • •6\.Male subjects with WOCBP partner who are willing to use male contraception (condom or sexual abstinence) from time point of administration of trial medication until 90 days thereafter.

Exclusion Criteria

  • •1\.Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
  • •2\.Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
  • •3\.Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • •4\.Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  • •5\.Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • •6\.Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication, except appendectomy or simple hernia repair
  • •7\.Diseases of the central nervous system, including but not limited to, any kind of seizures or stroke, and other relevant neurological or psychiatric disorders
  • •8\.History of relevant orthostatic hypotension, fainting spells, or blackouts
  • •9\.Chronic or relevant acute infections
  • •10\.History of relevant allergy or hypersensitivity, including allergy to the trial medication or its excipients

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Phase 1
A study in healthy Japanese men to test how well different dosesof BI 1569912 are toleratedMajor Dipressive Disorder
JPRN-jRCT2071210037Furuichi Takumi44
Not yet recruiting
Phase 1
A study in healthy Japanese men to test how well different doses of BI 764198 are toleratedA
JPRN-jRCT2071200055Ogawa Shintaro44
Completed
Phase 1
A study in healthy Japanese men to test how different doses of BI 1323495 are tolerated and how itraconazole influences the amount of BI 1323495 in the blood
JPRN-jRCT2071200056Katakabe Tetsuya74
Active, not recruiting
Not Applicable
The purpose of this study is to describe the pharmacokinetics of moxifloxacin in children to see what the best dose should be for children in the future. Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug.o medical condition specified as the purpose of this study is to describe the pharmacokinetics of moxifloxacin in children for future antibiotic treatment.Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
EUCTR2012-000737-40-Outside-EU/EEABayer HealthCare Pharmaceuticals36
Active, not recruiting
Phase 1
A study to test different doses of BI 836880 in patients with an eye disease called wet age-related macular degeneration (wAMD)wet age-related macular degeneration (wAMD)MedDRA version: 20.1Level: PTClassification code 10064930Term: Age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: LLTClassification code 10075568Term: Wet age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: LLTClassification code 10075718Term: Exudative age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
EUCTR2017-001221-40-DEBoehringer Ingelheim Pharma GmbH & Co. KG42