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

A First-in-Human, Randomised, Double Blind, Placebo Controlled, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: EA Pharma Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AJM347	Oral administration
DRUG	Placebo	Oral administration

Timeline

• Start date: 2017-07-25
• Primary completion: 2018-07-06
• Completion: 2018-07-06
• First posted: 2017-04-28
• Last updated: 2018-08-29

Locations

1 site across 1 country: United Kingdom