Drug-Drug Interaction (DDI)Phase 1NCT01943487
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 study testing EC905 and verapamil in people with Drug-Drug Interaction (DDI) and Healthy Subjects, run by Astellas Pharma Europe B.V. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug-Drug Interaction (DDI), Healthy Subjects
- What is being tested?
- EC905 and verapamil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2009to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index between 18.5 and 30.0 kg/m2, inclusive
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the detailed description
The effect of the co-administration of verapamil on the steady state PK of solifenacin succinate and tamsulosin HCl OCAS (Oral Controlled Absorption System) is evaluated in this study.
Verapamil has been chosen to represent the effect of moderate CYP3A4 inhibitors on the combined administration of solifenacin and tamsulosin given as combination tablet EC905.
Subjects are admitted to the clinic on Day -1. From Days 1-10, they receive one daily dose of EC905 to obtain steady state, followed by 20 days (Days 11-30) combined dosing of EC905 and verapamil.
On Day 10 a 24-hour PK profile is obtained for solifenacin/tamsulosin. After the last dosing on Day 30, a post-dose 24-hour PK profile for solifenacin/tamsulosin and verapamil is obtained.
Additionally, vital signs, safety ECG (Electrocardiogram) measurements, safety laboratory assessments, adverse events and concomitant medications are monitored throughout the investigational period.
Subjects return for an ESV (End of Study Visit) 10 days after the last dosing.
- Conditions
- Drug-Drug Interaction (DDI), Healthy Subjects
- Being tested
- EC905, verapamil
- Keywords
- Phase I, Verapamil, Tamsulosin OCAS, Solifenacin, Pharmacokinetics, EC905
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC905Drug
Also called tamsulosin OCAS and solifenacin
Oral
verapamilDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1: verapamil + EC905 | Experimental | Not described Receives: Drug: EC905; Drug: verapamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of tamsulosin OCAS in plasma: AUCtau
AUCtau (area under the plasma concentration-time curve during the time interval between consecutive dosing)
Measured: 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)
Measured: Predose, Days 1, and 7-10
Pharmacokinetics of tamsulosin OCAS in plasma: Cmax
Cmax (maximum concentration)
Measured: Predose, Days 1, and 7-10
Pharmacokinetics of solifenacin in plasma: Cmax
Cmax (maximum concentration)
Measured: Predose, Days 1, and 7-10
Secondary outcomes (2)
Pharmacokinetics of combined doses of tamsulosin OCAS and solifenacin in steady state, and verapamil
Plasma: Ctrough (trough concentration), tmax (time to attain Cmax), CL/F (apparent total body clearance), PTR (peak trough ratio) Urine: AUCtau, Cmax, Ctrough, CL/F, tmax
Measured: Predose, Days 27-30
Safety and tolerability of the interaction between combined doses of tamsulosin OCAS and solifenacin, and verapamil
AE (adverse events), clinical laboratory tests, vital signs, ECG, physical examination
Measured: Screening to ESV (10 days after the last dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Drug Interaction (DDI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943487
- Sponsor's protocol ID
- 905-CL-078
- Other IDs
- 2009-010841-29, 2009
- Status last verified
- May 2014
- First submitted
- 12 Sep 2013
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01943487
- Acronym / sponsor ID
- 905-CL-078
- Conditions
- Drug-Drug Interaction (DDI), Healthy Subjects
- Keywords
- Phase I, Verapamil, Tamsulosin OCAS, Solifenacin, Pharmacokinetics, EC905
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The effect of the co-administration of verapamil on the steady state PK of solifenacin succinate and tamsulosin HCl OCAS (Oral Controlled Absorption System) is evaluated in this study.
Verapamil has been chosen to represent the effect of moderate CYP3A4 inhibitors on the combined administration of solifenacin and tamsulosin given as combination tablet EC905.
Subjects are admitted to the clinic on Day -1. From Days 1-10, they receive one daily dose of EC905 to obtain steady state, followed by 20 days (Days 11-30) combined dosing of EC905 and verapamil.
On Day 10 a 24-hour PK profile is obtained for solifenacin/tamsulosin. After the last dosing on Day 30, a post-dose 24-hour PK profile for solifenacin/tamsulosin and verapamil is obtained.
Additionally, vital signs, safety ECG (Electrocardiogram) measurements, safety laboratory assessments, adverse events and concomitant medications are monitored throughout the investigational period.
Subjects return for an ESV (End of Study Visit) 10 days after the last dosing.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1: verapamil + EC905 | Experimental | Drug: EC905, Drug: verapamil |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Index between 18.5 and 30.0 kg/m2, inclusive
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EC905Also: tamsulosin OCAS and solifenacinOral | Drug | 1: verapamil + EC905 |
| verapamilOral | Drug | 1: verapamil + EC905 |
Primary outcome
Pharmacokinetics of tamsulosin OCAS in plasma: AUCtau
Time frame: Predose, Days 1, and 7-10
AUCtau (area under the plasma concentration-time curve during the time interval between consecutive dosing)
Pharmacokinetics of solifenacin in plasma: AUCtau
Time frame: Predose, Days 1, and 7-10
AUCtau (area under the plasma concentration-time curve during the time interval between consecutive dosing)
Pharmacokinetics of tamsulosin OCAS in plasma: Cmax
Time frame: Predose, Days 1, and 7-10
Cmax (maximum concentration)
Pharmacokinetics of solifenacin in plasma: Cmax
Time frame: Predose, Days 1, and 7-10
Cmax (maximum concentration)
2 secondary outcomes
Pharmacokinetics of combined doses of tamsulosin OCAS and solifenacin in steady state, and verapamil
Time frame: Predose, Days 27-30
Safety and tolerability of the interaction between combined doses of tamsulosin OCAS and solifenacin, and verapamil
Time frame: Screening to ESV (10 days after the last dosing)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Manager study chair
Astellas Pharma Europe B.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EC905 and verapamil in people with Drug-Drug Interaction (DDI) and Healthy Subjects, run by Astellas Pharma Europe B.V. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of tamsulosin OCAS in plasma: AUCtau (time frame: Predose, Days 1, and 7-10). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2014.