Healthy Participants
Conditions
Keywords
AJM347, pharmacokinetics, food effect study, pharmacodynamics
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.
Interventions
DRUGAJM347
Oral administration
DRUGPlacebo
Oral administration
Sponsors
EA Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with any adverse event (AE) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with abnormal, clinically significant physical examination findings | 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) | Clinical significance will be determined by the investigator. |
| Number of participants with abnormal, clinically significant vital sign values | 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) | Clinical significance will be determined by the investigator. |
| Number of participants with abnormal, clinically significant 12-lead electrocardiogram (ECG) values | 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) | Clinical significance will be determined by the investigator. |
| Inhibition rate of ligand-binding activity | Part 1, Days 1 and 2; Part 3, Days 1 and 2, Days 7, 9, and 10 | The rate of inhibition of ligand-protein binding will be measured. |
| Mean 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) | Blood samples will be collected at the specified time points for the determination of plasma concentrations of AJM347 and its metabolite. |
| Mean urinary concentrations of AJM347 and its metabolite | Part 1, Days 1 to 3; Part 3, Days 1 to 10 | Urine samples will be collected at the specified time points for the determination of urine concentrations of AJM347 and its metabolite. |
| Number of participants with abnormal, clinically significant clinical laboratory values | 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) | Clinical significance will be determined by the investigator. |
Countries
United Kingdom
Outcome results
None listed