EC905, Healthy Subjects, Pharmacokinetics
Conditions
Keywords
Phase I, Final formulation EC905, Solifenacin succinate, Tamsulosin HCl, Marketed drugs
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Astellas Pharma Europe B.V.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index between 18.5 and 30.0 kg/m2, inclusive
Exclusion criteria
* Known or suspected hypersensitivity to solifenacin, tamsulosin, EC905, Vesicare, Omnic OCAS or any of the components of the formulations used. * Any of the contraindications or precautions for use as mentioned in the applicable sections of the SPC's of tamsulosin or solifenacin. * Use of grapefruit (more than 3 x 200 ml) or marmalade (more than three times) in the week prior to admission to the Clinical Unit, as reported by the subject. * Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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® | Predose to Day 10 after dosing (22 times) | AUClast (Area under the curve until last sample taken), Cmax (Maximum concentration) |
| 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® | Predose to Day 10 after dosing (22 times) | AUClast (Area under the curve until last sample taken), Cmax (Maximum concentration) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of single doses of the final formulation combined EC905, marketed Vesicare® and marketed Omnic OCAS® | Screening to End of Study Visit (at least 7 days after the last on site period (treatment and PK sampling), or after withdrawal.) | Adverse events, clinical laboratory tests, vital signs, Electrocardiogram (ECG), physical examination |
| 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® | Predose to Day 10 after dosing (22 times) | 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) |
Countries
United Kingdom
Outcome results
None listed