A Study to Evaluate How Tamsulosin (at 1 Dose) and Solifenacin (at 2 Different Doses) Are Taken up From the Intestine, Distributed Through the Body and Eliminated From the Body When Administered in Combination as a Single Tablet (Called EC905)

NCT01953848 | Completed Phase 1

• 2 other identifiers: 905-CL-0532009-015078-36
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Tamsulosin (sold under the name Omnic OCAS) is used for treatment of voiding complaints related to an enlarged prostate. Solifenacin (sold under the name Vesicare) is used for the treatment of patients suffering from problems related to overactive bladder, such as needing to go to the toilet frequently and often having a sudden urgent need to go to the toilet. Certain patients with an enlarged prostate have complaints that may benefit from a combination of tamsulosin and solifenacin. EC905 is a single tablet containing both tamsulosin and solifenacin. The current study aims at investigating how tamsulosin and solifenacin are taken up from the intestine, distributed through the body and eventually eliminated from the body when taken as a single EC905 tablet.

Conditions

EC905; Pharmacokinetics; Multiple Dose; Healthy Subjects

Keywords

Phase I; Combination tablet EC905; Steady-state; Vesomni; VesiFlow; Urizia

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetic profile of tamsulosin HCl by Area Under the Curve during the time interval between consecutive dosing

  Area under the plasma concentration - time curve during the time interval between consecutive dosing (AUCtau)

  Days 10-12 and Days 13, 22-25 (26 times)

• Pharmacokinetic profile of tamsulosin HCl by Maximum concentration

  Maximum concentration ( Cmax)

  Days 10-12 and Days 13, 22-25 (26 times)

• Pharmacokinetic profile of solifenacin succinate by Area Under the Curve during the time interval between consecutive dosing

  Area under the plasma concentration - time curve during the time interval between consecutive dosing (AUCtau)

  Days 10-12 and Days 13, 22-25 (26 times)

• Pharmacokinetic profile of solifenacin succinate by Cmax (Maximum concentration)

  Maximum concentration ( Cmax)

  Days 10-12 and Days 13, 22-25 (26 times)

Secondary Outcomes (3)

• Pharmacokinetics profile of tamsulosin HCl concentration: Observed trough concentration, Peak Trough Ratio, time to attain Cmax,and apparent total body clearance

  Days 10-12 and Days 13, 22-25 (26 times)

• Pharmacokinetics profile of solifenacin succinate concentration: Observed trough concentration, Peak Trough Ratio, time to attain Cmax,and apparent total body clearance

  Days 10-12 and Days 13, 22-25 (26 times)

• Safety and tolerability of EC905

  Day -21 to End of Study Visit

Study Arms (2)

1: Low dose EC905

EXPERIMENTAL

Drug: EC905

2: High dose EC905

EXPERIMENTAL

Drug: EC905

Interventions

EC905 DRUG

Oral

Also known as: tamsulosin HCl and solifenacin succinate

1: Low dose EC905; 2: High dose EC905

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 tamsulosin HCl, solifenacin succinate, EC905 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 Summary of Product Characteristics (SPC) 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 clinic.
• Any of the liver function tests (i.e. ALT, AST) above the upper limit of normal.
• Any clinically significant history of asthma, eczema, any other clinically significant allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever).
• Any of the contraindications or precautions for use as mentioned in the applicable sections of the SPC's of tamsulosin or solifenacin.
• Abnormal pulse rate and/or blood pressure measurements at the pre-study visit as follows: pulse rate \<40 or \>90 bpm; mean systolic blood pressure \>160 mmHg; mean diastolic blood pressure \>100 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for at least 5 min; pulse rate will be measured automatically).
• A QT interval after repeated measurements of \>430 ms, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
• Use of any prescribed or OTC (over-the-counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for paracetamol (up to 3 g/day).
• Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampicin) in the 3 months prior to admission to the Clinical Unit.
• Any use of drugs of abuse within 3 months prior to admission to the Clinical Unit.
• History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the Clinical Unit.
• History of drinking more than 21 units of alcohol per week (1 unit = 10 g pure alcohol = 250 ml of beer (5%) or 35 ml of spirits (35%) or 100 ml of wine (12%)) within 3 months prior to admission to the Clinical Unit.
• Donation of blood or blood products within 3 months prior to admission to the Clinical Unit.
• Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (1)

Parexel Early Phase Clinical Unit

Harrow, H1 3UJ, United Kingdom

Location

MeSH Terms

Interventions

Tamsulosin; Solifenacin Succinate

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Medical Monitor

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 1, 2013
• Study Start: April 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

GB (1)