drugset / Trial / NCT04908800

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KRP-A218 in Healthy Subjects

NCT04908800 ↗

Phase 1 Completed 99 enrolled Kyorin Pharmaceutical Co.,Ltd
RandomizedSequentialDouble-blindTreatment

Summary

This first-in-human study has three parts. In Parts A and B, the safety, tolerability, and pharmacokinetics (PK) will be evaluated following administration of single and multiple doses of KRP-A218, including food-effect. In Part C, the drug-drug interaction (DDI) with itraconazole will be evaluated.

Timeline

Start
2021-05-27
Primary completion
2022-04-21
Completion
2022-04-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule 10 mg/ml Oral
Subject KRP-A218 Unknown — Oral

Indications

No indication recorded.