Covance Clinical Research Unit (CRU) Ltd
Leeds, United Kingdom
NCT Number: NCT03133468
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.
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Leeds, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Main Inclusion Criteria for all participants:
Main Inclusion Criteria for Japanese participants:
Main Inclusion Criteria for Caucasian participants:
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.
Oral administration
Oral administration
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)
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)
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)
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)
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)
Clinical significance will be determined by the investigator.
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)
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 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.
Time frame: 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.
EA Pharma Co., Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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