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Clinical Trials/JPRN-jRCT2071210008
JPRN-jRCT2071210008
Completed
Phase 1

A phase 1 open-label study evaluating the pharmacokinetics and mass balance of [14C] TAS-205 in healthy volunteers

asermoaddeli Ali0 sites6 target enrollmentApril 9, 2021
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ConditionsDuchenne Muscular Dystrophy

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Duchenne Muscular Dystrophy
Sponsor
asermoaddeli Ali
Enrollment
6
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 9, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
asermoaddeli Ali

Eligibility Criteria

Inclusion Criteria

  • •(1\) Healthy adult male subjects who provided written informed consent to participate in the study
  • •(2\) Aged 20 years or older and younger than 40 years at the time of informed consent
  • •(3\) Capable of oral intake.
  • •(4\) Body weight of 50 kg or more and body mass index of 18\.5 or more and less than 25\.0

Exclusion Criteria

  • •(1\) Had current or previous hypersensitivity or allergy to drugs
  • •(2\) Had current or previous drug abuse (including use of illicit drugs) or alcoholism
  • •(3\) Had any concurrent disease (including symptoms and signs; however, diseases that do not affect evaluations in the study such as asymptomatic pollinosis and wart are excluded)
  • •(4\) Consumed foods or beverages containing the St. John's Wort within 28 days before study drug administration
  • •(5\) Had blood pressure, pulse rate, and body temperature meeting any of the following at screening:
  • •Systolic blood pressure: \<90 mmHg or \>\=140 mmHg
  • •Diastolic blood pressure: \<40 mmHg or \>\=90 mmHg
  • •Pulse rate: \<40 beats per minute (bpm) or \>\=100 bpm
  • •Body temperature: 35\.0 or \>\= 37\.1

Outcomes

Primary Outcomes

Not specified

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