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Clinical Trials/jRCT2031210202
jRCT2031210202CompletedNot Applicable

A Phase 1 study of S-217622 in healthy adult participants

Shionogi & Co., Ltd.0 sites201 target enrollmentStarted: July 22, 2021Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
201
Primary Endpoint
-
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized Controlled Trial
Intervention Model
Parallel Assignment
Primary Purpose
Treatment Purpose
Masking
Double Blind

Eligibility Criteria

Ages
20age old over to 55age old under (—)
Sex
All

Inclusion Criteria

  • •Japanese healthy adult male participants (SAD Part, DDI with dexamethasone and prednisolone Part)
  • •Japanese healthy adult male, white healthy adult male or Japanese healthy adult female participants (MAD Part)
  • •Japanese healthy adult male and female participants (FE Part, DDI with midazolam Part)
  • •White healthy adult male and female participants (W-MAD Part)
  • •Participants must be 20 to 55 years of age inclusive, at the time of signing the informed consent form (SAD Part, MAD Part, DDI Part, FE Part, W-MAD Part)
  • •Participants must be 65 years of age or older inclusive, at the time of signing the informed consent form (Elderly Part)

Exclusion Criteria

  • •History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
  • •Positive SARS-CoV-2 RT-PCR test at admission

Outcomes

Primary Outcomes

-

Adverse events, physical examination, laboratory tests, vital signs, 12-lead ECG, holter ECG Pharmacokinetics (SAD Part, MAD Part, W-MAD Part, Elderly Part) Dexamethasone, prednisolone, and midazolam: Cmax, Tmax, AUC0-last, AUC0-inf, t1/2,z, lambdaz, MRT, CL/F, Vz/F (DDI Part) S-217622: Cmax, Tmax, AUC0-last, AUC0-inf, t1/2,z, lambdaz, MRT, CL/F, Vz/F (FE Part)

Secondary Outcomes

No secondary outcomes reported

Investigators

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A Phase 1 study of S-217622 | Clinical Trial