A Study in Healthy Volunteers Comparing Two Different Liquid Formulations of Solifenacin With Each Other and With the Tablet Formulation

NCT01406158 | Completed Phase 1

• 1 other identifier: 905-CL-080
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A study in healthy volunteers comparing two different liquid formulations of solifenacin with each other and with the tablet formulation.

Conditions

Pharmacokinetics of Solifenacin Succinate; Healthy Volunteers

Keywords

Solifenacin succinate; VESIcare; Healthy Volunteers; YM905

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic assessment of AUC and maximum concentration (Cmax) through the analysis of blood samples

  Up to Day 11

Study Arms (3)

Treatment A

EXPERIMENTAL

Drug: Solifenacin Succinate Formulation A

Treatment B

EXPERIMENTAL

Drug: Solifenacin Succinate Formulation B

Treatment T

EXPERIMENTAL

Drug: Solifenacin Succinate

Interventions

Solifenacin Succinate Formulation A DRUG

oral suspension

Also known as: YM905

Treatment A

Solifenacin Succinate Formulation B DRUG

oral suspension

Also known as: YM905

Treatment B

Solifenacin Succinate DRUG

oral tablet

Also known as: VESIcare, YM905

Treatment T

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject weighs at least 45 kg, and has a body mass index of 18 to 32 kg/m2
• Subject has a normal 12-lead electrocardiogram (ECG)
• Subject, if female, must be at least 2 years postmenopausal, surgically sterile, or practicing effective birth control, and is not pregnant or lactating
• Subject has good venous access

You may not qualify if:

• The subject has a history of any clinically significant disease or malignancy with the exception of non-melanoma skin cancer
• The subject has a history of or currently has evidence of urinary retention, gastric retention, or uncontrolled narrow-angle-glaucoma
• The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes)
• The subject has a known hypersensitivity to VESIcare® or any of the excipients in the formulations, or the subject has a history of severe allergic or anaphylactic reactions
• The subject has a history of consuming more than 15 units of alcoholic beverages per week, or has a history of alcoholism or substance abuse within the past two years prior to screening (Note: one unit = 12 ounces of beer, 4 ounces of wine, or 1 ounce of spirits)
• The subject has used tobacco containing products or nicotine containing products within past six months
• The subject has a supine mean systolic blood pressure \< 90 or \> 160 mmHg and a mean diastolic blood pressure \< 50 or \> 90 mmHg, or pulse rate \< 40 or \>100 beats per minute
• The subject is known to be positive for human immunodeficiency virus antibody
• The subject has a positive test for hepatitis C antibody or hepatitis B antigen
• The subject's laboratory test results are outside the normal limits and considered to be clinically significant
• The subject anticipates an inability to abstain from alcohol or caffeine use throughout the duration of the study or from grapefruit, Seville oranges, star fruit, or any products containing these items from throughout the duration of the study
• The subject has received an experimental agent within past 30 days or ten half-lives, whichever is longer
• The subject has had any significant blood loss
• The subject has any clinically significant history of gastrointestinal symptoms such as nausea, abdominal discomfort or upset, or heartburn in the four weeks prior to clinic admission, or a history of any gastrointestinal surgery except for appendectomy or cholecystectomy

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Spaulding Clinical Research

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

Solifenacin Succinate

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: August 1, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 24, 2011

Record last verified: 2011-08

Locations

US (1)