Clinical 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: AJM347
pharmacokinetics
food effect study
pharmacodynamics
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-28
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with any adverse event (AE)
timeFrame: 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 outcomes:
measure: Number of participants with abnormal, clinically significant physical examination findings
timeFrame: 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)
measure: Number of participants with abnormal, clinically significant vital sign values
timeFrame: 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)
measure: Number of participants with abnormal, clinically significant 12-lead electrocardiogram (ECG) values
timeFrame: 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)
measure: Number of participants with abnormal, clinically significant clinical laboratory values
timeFrame: 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)
measure: Mean plasma concentrations of AJM347 and its metabolite
timeFrame: 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)
measure: Mean urinary concentrations of AJM347 and its metabolite
timeFrame: Part 1, Days 1 to 3; Part 3, Days 1 to 10
measure: Inhibition rate of ligand-binding activity
timeFrame: Part 1, Days 1 and 2; Part 3, Days 1 and 2, Days 7, 9, and 10
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit (CRU) Ltd
Study officials:
References: