Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis
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|ClinicalTrials.gov Identifier: NCT01872026|
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : November 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy Pharmacodynamics of ASP7991 Pharmacokinetics 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|
|Actual Study Start Date :||December 26, 2012|
|Actual Primary Completion Date :||June 26, 2013|
|Actual Study Completion Date :||June 26, 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872026
|Study Director:||Medical Director||Astellas Pharma Inc|