drugset / Trial / NCT03133468

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State

NCT03133468 ↗

Phase 1 Completed 200 enrolled EA Pharma Co., Ltd.
RandomizedParallel-groupTriple-blindBasic science

Summary

This study will be conducted to determine the safety and tolerability of single and multiple oral ascending doses of AJM347 in healthy male participants, and to assess the pharmacodynamic response following single and multiple oral ascending doses of AJM347 in the same population. This study will also aim to determine the single and multiple oral ascending dose pharmacokinetics of AJM347 and its metabolite in healthy male participants, and to determine the effect of food on the single and multiple oral dose pharmacokinetics of AJM347 and its metabolite in the same population.

Timeline

Start
2017-07-25
Primary completion
2018-07-06
Completion
2018-07-06

Drugs

EvaluationDrugModalityDoseRoute
Subject AJM347 Unknown — Oral

Indications

No indication recorded.