JPRN-jRCT2080225163CompletedPhase 1
KRP-AM1977X Phase I Clinical Study -Examination of safety, pharmacokinetics and effects on gut microbiome after single and repeated oral administration in healthy adults
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 54
Study Overview
Brief Summary
In a phase I clinical study of KRP-AM1977X in healthy Japanese adult males, the safety of KRP-AM1977X was not significantly affected in a single oral dose study up to 800 mg and in a repeated oral dose study up to 400 mg once daily for 7 days, confirming its tolerability.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to <= 40age old (—)
- Sex
- Male
Inclusion Criteria
- •Person with BMI that is more than 18.5 but less than 25.0, etc.
Exclusion Criteria
- •Drug allergy (including drug allergy to mydriatic agent), food allergy or atopy, and those who have a history of it
Investigators
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