A Phase 1 interventional study of EC905 and solifenacin in EC905, Pharmacokinetics and Healthy Subjects, sponsored by Astellas Pharma Europe B.V.. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-29.
Sponsored by Astellas Pharma Europe B.V. · Phase 1, Interventional, and Basic science
A study to assess the amount of drug in the blood of young to middle aged, healthy, male subjects after they received the final formulation of EC905 compared to solifenacin (Vesicare®) and tamsulosin OCAS (Omnic OCAS®).
Subjects are given a single dose of the combination tablet EC905, Vesicare® and Omnic OCAS® in 3 separate periods.
The subjects are randomized to one of 6 treatment sequence groups.
Subjects are admitted to the clinical unit on Day -1 for pre-dose assessments. They remain in the clinic for two periods of 11 days and one period of 14 days.
After randomization the subjects receive a single dose treatment on Day 1 followed by blood sampling for pharmacokinetic (PK) assessment. For both EC905 and Vesicare®, blood sampling continues for 10 days after dosing; for Omnic OCAS®, it continues for 3 days after dosing.
Each period is separated by a wash-out period of at least 4 day, and subjects are checked for eligibility again one day prior to the start of a new dosing day.
Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications are monitored throughout the investigational period.
A blood sample is drawn for CYP2D6 genotyping, in order to evaluate the effect of the CYP2D6 genotype on the PK of tamsulosin.
Subjects return for an End of Study Visit (ESV) 7 days after the last on-site period, or after withdrawal.
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:
Drug: EC905
Drug: solifenacin
Drug: tamsulosin
Oral
oral
Also known as: Vesicare®
oral
Also known as: Omnic OCAS®
The Pharmacokinetics (PK) of solifenacin after a single dose of the final formulation of the combination tablet EC905 with a single dose of Vesicare® and Omnic OCAS®
AUClast (Area under the curve until last sample taken), Cmax (Maximum concentration)
Time frame: Predose to Day 10 after dosing (22 times)
The Pharmacokinetics (PK) of tamsulosin HCl after a single dose of the final formulation of the combination tablet EC905 with a single dose of Vesicare® and Omnic OCAS®
AUClast (Area under the curve until last sample taken), Cmax (Maximum concentration)
Time frame: Predose to Day 10 after dosing (22 times)
The PK of solifenacin and tamsulosin HCl after a single dose of the final formulation of the combination tablet EC905 with a single dose of Vesicare® and Omnic OCAS®
AUCinf (AUC extrapolated until infinity), t1/2 (Apparent terminal elimination half-life), tmax (Time to attain Cmax), CL/F (Apparent total body plasma clearance), Vz/F (Apparent volume of distribution)
Time frame: Predose to Day 10 after dosing (22 times)
Safety and tolerability of single doses of the final formulation combined EC905, marketed Vesicare® and marketed Omnic OCAS®
Adverse events, clinical laboratory tests, vital signs, Electrocardiogram (ECG), physical examination
Time frame: Screening to End of Study Visit (at least 7 days after the last on site period (treatment and PK sampling), or after withdrawal.)
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Europe B.V.