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Clinical Trials/jRCT2080222333
jRCT2080222333
Unknown
Phase 1

Open-label study to assess safety, pharmacokinetics and exposed dose of NMK20 in healthy Japanese male subjects

Nihon Medi-Physics Co., Ltd.0 sites6 target enrollmentTBD
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Nihon Medi-Physics Co., Ltd.
Enrollment
6
Primary Endpoint
Assessment of subjective/objective symptoms
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
jrct.mhlw.go.jp
Start Date
TBD
End Date
TBD
Last Updated
Recently
Study Type
Interventional
Study Design
Uncontrolled, Single-dose, Open-label
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Body weight: 50.0 kg or more
  • •Body mass index: 18.5 and more - 25.0 below

Exclusion Criteria

  • •Subjects with abnormality found by liver function test or renal function test.
  • •Subjects with a hypersensitive history to drugs or foods.
  • •Subjects who have abused or are abusing drugs.
  • •Subjects who were or are addicted to alcohol.
  • •Subjects who have received an investigational new drug other than NMK20 from six months before screening up to hospital admission.

Outcomes

Primary Outcomes

Assessment of subjective/objective symptoms

Assessment of subjective/objective symptoms

Electrocardiogram exams

Electrocardiogram exams

Vital signs

Vital signs

Clinical tests

Clinical tests

Secondary Outcomes

  • Assessment of radioactivity in blood, radioactivity distribution rate in organs/tissue and urinary excretion rate of radioactivity
  • Assessment of unchanged drug and radioactive metabolites in blood plasma and urine
  • Calculation of exposed dose by medical internal radiation dose(MIRD) method

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