A Phase 1 interventional study of FYU-981, (Oral single dosing) in Renal Insufficiency and Healthy, sponsored by Fuji Yakuhin Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-06.
Sponsored by Fuji Yakuhin Co., Ltd. · Phase 1, Interventional, and Basic science
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with renal insufficiency and with normal renal function.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 18 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Fuji Yakuhin Co., Ltd. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
(eGFR: \>=30mL/min/1.73m\^2 and \< 60mL/min/1.73m\^2)
Drug: FYU-981, (Oral single dosing)
(eGFR: \>=60mL/min/1.73m\^2 and \< 90mL/min/1.73m\^2)
Drug: FYU-981, (Oral single dosing)
(eGFR: \>=90mL/min/1.73m\^2)
Drug: FYU-981, (Oral single dosing)
FYU-981, (Oral single dosing)
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time frame: 48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time frame: 48 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time frame: 48 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time frame: 48 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time frame: 48 hours
Pharmacokinetics (kel: Elimination rate constant)
Time frame: 48 hours
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Time frame: 48 hours
Pharmacokinetics (MRT: Mean residence time)
Time frame: 48 hours
Pharmacokinetics (Ae: Amount of drug excreted in urine)
Time frame: 48 hours
Pharmacokinetics (fe: Fraction of dose excreted in urine)
Time frame: 48 hours
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Fuji Yakuhin Co., Ltd.