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Clinical Trials/JPRN-jRCT2080223418
JPRN-jRCT2080223418CompletedPhase 1

A Phase 1 Study of CS-3150 Evaluation of Safety, Pharmacokinetics, and Pharmacodynamics after Single Oral Administration in Japanese Healthy Adult Male Subjects

DAIICHI SANKYO Co.,Ltd.0 sites48 target enrollmentStarted: December 22, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
48
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

o safety concern was noted in single oral administration of esaxerenone at a dose of 5 mg to 200 mg in Japanese healthy adult subjects.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 20age old to <= 45age old (—)
Sex
Male

Inclusion Criteria

  • •1)Japanese male
  • •2)Persons >= 20 years and =< 45 years of age at the time of informed consent
  • •3)Persons with a body mass index (BMI; calculated by body weight [kg]/height [m]2) of >= 18.5 kg/m2 and < 25.0 kg/m2 at the screening examination

Exclusion Criteria

  • •1)Persons with hypersensitivity or idiosyncratic reactions to a drug, (such as penicillin allergy)
  • •2)Persons with drug or alcohol dependence

Investigators

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