A Study to Evaluate Whether Verapamil Has an Effect on the Uptake and Elimination of Solifenacin and Tamsulosin When Administered in a Combination Tablet
A Phase 1, Open-label, One-sequence Study to Assess the Effect of Verapamil on the Steady State Pharmacokinetics of Solifenacin and Tamsulosin Administered as a Combination Tablet EC905 in Healthy Male Subjects.
2 other identifiers
interventional
36
1 country
1
Brief Summary
This study investigates the effect of the co-administration of verapamil on the steady-state pharmacokinetics (PK) of solifenacin succinate and tamsulosin given as a combination tablet, EC905.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 12, 2013
CompletedFirst Posted
Study publicly available on registry
September 17, 2013
CompletedMay 30, 2014
May 1, 2014
4 months
September 12, 2013
May 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Pharmacokinetics of tamsulosin OCAS in plasma: AUCtau
AUCtau (area under the plasma concentration-time curve during the time interval between consecutive dosing)
Predose, Days 1, and 7-10
Pharmacokinetics of solifenacin in plasma: AUCtau
AUCtau (area under the plasma concentration-time curve during the time interval between consecutive dosing)
Predose, Days 1, and 7-10
Pharmacokinetics of tamsulosin OCAS in plasma: Cmax
Cmax (maximum concentration)
Predose, Days 1, and 7-10
Pharmacokinetics of solifenacin in plasma: Cmax
Cmax (maximum concentration)
Predose, Days 1, and 7-10
Secondary Outcomes (2)
Pharmacokinetics of combined doses of tamsulosin OCAS and solifenacin in steady state, and verapamil
Predose, Days 27-30
Safety and tolerability of the interaction between combined doses of tamsulosin OCAS and solifenacin, and verapamil
Screening to ESV (10 days after the last dosing)
Study Arms (1)
1: verapamil + EC905
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Body Mass Index between 18.5 and 30.0 kg/m2, inclusive
You may not qualify if:
- Known or suspected hypersensitivity to EC905 or any of the components of the formulation used
- Known or suspected hypersensitivity to verapamil or any of the components of the formulation used
- Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SGS Aster
Paris, 75015, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Study Manager
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2013
First Posted
September 17, 2013
Study Start
August 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
May 30, 2014
Record last verified: 2014-05