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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
200
Oral administration
Oral administration
Covance Clinical Research Unit (CRU) Ltd
Leeds, United Kingdom
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.
Time frame: 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)
Number of participants with abnormal, clinically significant physical examination findings
Clinical significance will be determined by the investigator.
Time frame: 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)
Number of participants with abnormal, clinically significant vital sign values
Clinical significance will be determined by the investigator.
Time frame: 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)
Number of participants with abnormal, clinically significant 12-lead electrocardiogram (ECG) values
Clinical significance will be determined by the investigator.
Time frame: 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)
Number of participants with abnormal, clinically significant clinical laboratory values
Clinical significance will be determined by the investigator.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: Part 1, Days 1 to 3; Part 3, Days 1 to 10
Inhibition rate of ligand-binding activity
The rate of inhibition of ligand-protein binding will be measured.
Time frame: Part 1, Days 1 and 2; Part 3, Days 1 and 2, Days 7, 9, and 10
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