Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis
|ClinicalTrials.gov Identifier: NCT01872026|
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : July 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy Pharmacokinetics of ASP7991 Pharmacodynamics of ASP7991||Drug: ASP7991||Phase 1|
To examine the pharmacokinetics, pharmacodynamics and safety in patients with chronic kidney disease undergoing hemodialysis.
- To assess the pharmacokinetics (PK), pharmacodynamics (PD), safety and the effect of hemodialysis on PK of single oral administration of ASP7991 in Part 1.
- To assess the safety, PK and PD of repeated oral administration of ASP7991 in part 2.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||ASP7991 Clinical Pharmacological Study -Examination of Pharmacokinetics and Pharmacodynamics in Chronic Kidney Disease Patients Undergoing Hemodialysis|
|Study Start Date :||November 2012|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
Experimental: Part 1- single administration
The lowest, middle and the highest dose ASP7991 as a single oral administration on non-dialysis day in step 1 to 3 and the highest dose on day of dialysis in step 4.
Experimental: Part 2- repeated administration
The lowest, middle and the highest dose ASP7991 as repeated oral administration in step 1 to 3.
- The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs, ECGs for QT evaluation and ophthalmic examination [ Time Frame: For 9-16 days after dosing ]
- Plasma concentrations unchanged drug; AUClast, AUCinf, AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F [ Time Frame: For 9-16 days after dosing ]
- iPTH, wPTH, corrected serum Ca* (Serum Ca and Serum Alb), P [ Time Frame: For 9-16 days after dosing ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872026
|Study Director:||Medical Director||Astellas Pharma Inc|