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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133468
• Other study ID #: AJM347/CP1
• Secondary ID: 2017-000259-1710
• Status: Completed
• Phase: Phase 1
• Start date: July 25, 2017
• Est. completion date: July 6, 2018

Study information

• Verified date: July 2018
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 6, 2018
• Est. primary completion date: July 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

Main Inclusion Criteria for all participants:

• Participants will be male

• Participants will be in good health

Main Inclusion Criteria for Japanese participants:

• Be =20 to =45 years of age

• Have body mass index (BMI) =18.5 to =25.0 kilograms per meters squared (kg/m^2)

• Be Japanese

Main Inclusion Criteria for Caucasian participants:

• Be =18 to =45 years of age

• Have a BMI =18.5 to =30.0 kg/m^2

• Be Caucasian

Exclusion Criteria:

Main Exclusion Criteria for all participants:

Participants will be excluded from the study if they satisfy any of the following criteria at the Screening visit, unless otherwise stated.

• Participants who have donated or lost =200 milliliters (mL) blood within 1 month or =400 mL within 3 months prior to Check-in

• Participants who have an abnormality in heart rate, blood pressure, temperature, or respiration rate at Screening

• Participants who have:

• a positive urine drugs of abuse screen;

• a positive alcohol breath test

• Participants who have an abnormality in the 12-lead electrocardiogram (ECG) at Screening

• Participants who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to first dose administration

• Participants who have a significant history of drug allergy, as determined by the Investigator

• Participants who have any clinically significant abnormal physical examination finding

• Participants who:

• are carriers of the hepatitis B surface antigen (HBsAg);

• are carriers of the hepatitis C antibody;

• have a positive result for the test for human immunodeficiency virus (HIV) antibodies

• Participants who, in the opinion of the Investigator, should not participate in this study

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• AJM347
Oral administration
• Placebo
Oral administration

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit (CRU) Ltd	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
EA Pharma Co., Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with any adverse event (AE)	An AE is any untoward medical occurrence in a patient or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product.	Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Secondary	Number of participants with abnormal, clinically significant physical examination findings	Clinical significance will be determined by the investigator.	Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Secondary	Number of participants with abnormal, clinically significant vital sign values	Clinical significance will be determined by the investigator.	Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Secondary	Number of participants with abnormal, clinically significant 12-lead electrocardiogram (ECG) values	Clinical significance will be determined by the investigator.	Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Secondary	Number of participants with abnormal, clinically significant clinical laboratory values	Clinical significance will be determined by the investigator.	Part 1, up to Days 7 to 9; Part 2, up to Days 7 to 9; Part 3, up to Day 15 (Parts 1, 2, and 3 are not continuous)
Secondary	Mean plasma concentrations of AJM347 and its metabolite	Blood samples will be collected at the specified time points for the determination of plasma concentrations of AJM347 and its metabolite.	Part 1, Days 1 to 3; Part 2, Days 1 to 3; Part 3, Days 1 to 3, Day 7, Days 9 to 11 (Parts 1, 2, and 3 are not continuous)
Secondary	Mean urinary concentrations of AJM347 and its metabolite	Urine samples will be collected at the specified time points for the determination of urine concentrations of AJM347 and its metabolite.	Part 1, Days 1 to 3; Part 3, Days 1 to 10
Secondary	Inhibition rate of ligand-binding activity	The rate of inhibition of ligand-protein binding will be measured.	Part 1, Days 1 and 2; Part 3, Days 1 and 2, Days 7, 9, and 10