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Clinical Trials/JPRN-jRCT2071210037
JPRN-jRCT2071210037
Recruiting
Phase 1

Safety, tolerability and pharmacokinetics of single rising oral doses andmultiple oral doses of BI 1569912 in healthy male Japanese subjects(single-blind, partially randomized within dose groups, placebocontrolled,parallel-group design)

Furuichi Takumi0 sites44 target enrollmentJune 23, 2021
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ConditionsMajor Dipressive Disorder

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Major Dipressive Disorder
Sponsor
Furuichi Takumi
Enrollment
44
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 23, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
Furuichi Takumi

Eligibility Criteria

Inclusion Criteria

  • •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
  • •Japanese ethnicity
  • •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 GCP and local legislation

Exclusion Criteria

  • •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 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

Outcomes

Primary Outcomes

Not specified

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