A Phase 1 interventional study of ASP7962 and Placebo in Safety, Tolerability and Pharmacokinetics of ASP7962, sponsored by Astellas Pharma Europe B.V.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-11.
Sponsored by Astellas Pharma Europe B.V. · Phase 1, Interventional, and Basic science
The purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolized (chemically broken down), distributed through the body and excreted. A further aim is to look at how this process is possibly altered by food by giving the study drug in the presence and absence of meals.
Astellas Pharma Europe B.V. is the lead sponsor of 93 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each dose level group will include 8 subjects, of which 6 will be randomized to receive active ASP7962
Drug: ASP7962
Each dose level group will include 8 subjects, of which 2 will be randomized to receive placebo
Drug: Placebo
Oral
Oral
Safety assessed by: clinical laboratory tests, vital signs, Electrocardiogram (ECG), Adverse Events (AEs), real time and continuous cardiac monitoring, orthostatic challenge test, and C-SSRS
Day 1 to End of Study Visit: Routine clinical laboratory tests (hematology, biochemistry \[additionally including testosterone, luteinizing hormone {LH}, follicle-stimulating hormone {FSH}, inhibin b, sex hormone-binding globulin {SHBG}\] and urinalysis), Vital Signs, ECG, A Es Day 1: Real-time cardiac monitoring Day 1 to Day 2: Continuous cardiac monitoring and orthostatic challenge test Day -1 and End of Study Visit: C-SSRS for suicidality risk
Time frame: Day -1 through End of Study Visit (7 to 14 days after (early) discharge from the clinical unit (only after the second treatment period for subjects required to return for the food-effect part of the clinical study))
Pharmacokinetics of ASP7962 in plasma and urine
Measurement of ASP7962 in plasma and urine under fasted and fed conditions. Plasma: AUCinf, AUCinf,u, AUClast, AUClast,u, Cmax, Cmax,u, CL/F, CLu/F, fu, tlag, tmax, t½, Vz/F, Vz,u/F Urine: Aelast, Aeinf, Aelast%, Aeinf%, CLR, CLR,u
Time frame: Day 1 to Day 7
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Europe B.V.