EC905 Pharmacokinetic Profile Study

NCT02634489 | Completed Phase 1

• 2 other identifiers: 905-CL-0712007-005155-41
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

A study to compare the pharmacokinetics of tamsulosin HCl and solifenacin succinate after co-administration of single entity tablets and of the combination tablet EC905 under steady state conditions at three dose strengths.

Conditions

Phase 1; Healthy; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Keywords

Bladder outlet obstruction; Overactive bladder; Urinary incontinence; Omnic OCAS®; Vesicare®; Tamsulosin hydrochloride; Solifenacin succinate

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK) of tamsulosin HCl and solifenacin succinate in plasma: AUCtau

  AUCtau: area under the concentration - time curve (AUC) during the time interval between consecutive dosing

  Day 12

• PK of tamsulosin HCl and solifenacin succinate in plasma: Cmax

  Cmax: maximum concentration

  Day 12

Secondary Outcomes (4)

• Safety profile assessed by adverse events, physical examination and vital signs, routine safety laboratory tests, and 12-lead ECG

  Day 0 up to and including the post study visit (the PSV is scheduled between 7 to 14 days after (early) discharge on study day 13)

• PK profile Ctrough

  Day 10, 11, 12, 13

• PK profile PTR

  Day 12

• PK profile Tmax

  Day 12

Study Arms (2)

Tamsulosin HCl and Solifenacin Succinate

ACTIVE COMPARATOR

Participants will receive daily doses of tamsulosin HCL and Solifenacin Succinate (3 dose strengths) as single tablets.

Drug: Tamsulosin HCl; Drug: Solifenacin Succinate

EC905 (tamsulosin HCI and solifenacin succinate)

ACTIVE COMPARATOR

Participants will receive a fixed combination tablet (3 dose strengths).

Drug: EC905

Interventions

Tamsulosin HCl DRUG

Oral

Also known as: Omnic OCAS®

Tamsulosin HCl and Solifenacin Succinate

Solifenacin Succinate DRUG

Oral

Also known as: Vesicare®

Tamsulosin HCl and Solifenacin Succinate

EC905 DRUG

Oral

Also known as: Vesomni®

EC905 (tamsulosin HCI and solifenacin succinate)

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.

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 liver function tests above the upper limit of normal at repeated measurements.
• Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any other drug (excluding non-active hay fever).
• Subject is at risk of urinary retention based on medical history.
• A planned cataract surgery within 30 days after completion of the study.
• Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests.
• 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 5 min; pulse will be measured automatically).
• A marked baseline prolongation of QT/QTc interval after repeated measurements of 450 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 occasional use of paracetamol (up to 3 g/day).
• Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) 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 = 270 cc of beer or 40 cc of spirits or 1 glass of wine) 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)

Site NL1

Zuidlaren, Drenthe, 9471 GP, Netherlands

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Urinary Bladder Neck Obstruction; Urinary Bladder, Overactive; Urinary Incontinence

Interventions

Tamsulosin; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urination Disorders

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

• Director Medical Sciences

  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: December 16, 2015
• First Posted: December 18, 2015
• Study Start: March 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

NL (1)