Site JP00001
Tokyo, Japan
NCT Number: NCT02693613
The objective of this study is to evaluate the effect of Kremezin® on the pharmacokinetics of single dose of ASP1517 in healthy non-elderly adult male subjects when administered concomitantly or in a time separated manner.
Looking for future studies?
Notify Me20 year–44 year
Male
Interventional
Phase 1
Tokyo, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral
Oral
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
Cmax: Maximum concentration
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
CL/F: Apparent total systemic clearance
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
t1/2: Terminal elimination half-life
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
tmax: Time of Cmax
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
tlag: Time point prior to the time point corresponding to the first measurable (non-zero) concentration
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
Vz/F: Apparent volume of distribution during the terminal elimination phase
Time frame: Up to 72 hours after final study drug dosing
Time frame: Up to 72 hours after each study drug dosing
Supine blood pressure, supine pulse rate and axillary body temperature
Time frame: Up to 72 hours after each study drug dosing
Hematology, blood biochemistry and urinalysis
Time frame: Up to 72 hours after each study drug dosing
ECG: Electrocardiogram
Astellas Pharma Inc
Industry
Pharmacokinetic Study of ASP1517 - Evaluation of the Effect of Kremezin® on the Pharmacokinetics of ASP1517 in Non-elderly Healthy Adult Male Subjects, When Administered Concomitantly or in a Time Separated Manner.
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.
Published trials that share one or more normalized conditions with this study.
NCT05447078
Healthy Volunteers, Infections
Jackson, Mississippi, United States
View Trial DetailsNCT07513532
Healthy Volunteers
Seattle, Washington, United States
View Trial DetailsNCT07090655
Healthy Volunteers
Brisbane, Australia
View Trial DetailsNCT01915212
Communicable Diseases, DNA Virus Infections
Bethesda, Maryland, United States
View Trial Details