EA Pharma Trial Site
Higashi, Fukuoka, Japan
NCT Number: NCT03922633
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after a single intravenous dose of E3112 in Japanese healthy adult male participants.
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Notify Me20 year–44 year
Male
Interventional
Phase 1
Higashi, Fukuoka, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous infusion.
Intravenous infusion.
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
Cmax is the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
Tmax is the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
AUC 0-t is area under the concentration-time curve from time 0 to time of last quantifiable concentration for E3112.
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
AUC∞ is area under the concentration-time curve from time 0 to infinity of E3112.
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
t1/2 is the time required for the concentration of the drug to reach half of its original value.
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
CL is defined as the rate of drug elimination divided by the plasma concentration of the drug.
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
Vd is the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma.
Time frame: Day 1 to Day 43
Time frame: Day 1 to Day 43
Time frame: Day 1 to Day 43
Time frame: Day 1 to Day 43
Time frame: Day 1 to Day 43
Time frame: Day 1 to Day 43
Time frame: Day 1 to Day 43
Time frame: Day 1 to Day 43
Time frame: Day 1 to Day 43
EA Pharma Co., Ltd.
Industry
A Phase 1 Clinical Study of a Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Subjects
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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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