A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers
August 17, 2016 updated by: Pfizer
Open-Label, Single-Dose, Randomized, Crossover Study To Estimate The Effects Of Food On The Pharmacokinetics Of Two Fesoterodine Sustained-Release Beads-In-Capsule Formulations And To Estimate The Relative Bioavailability Of One Or Both Formulations Compared To Commercial Tablet Formulation In Healthy Adult Volunteers
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics (process by which drug fesoterodine is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of the drug.
This study will take place over approximately 8 weeks and will consist of a screening visit to determine eligibility for the study, and 2- or 3-period treatment phase for each cohort.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Singapore, Singapore, 188770
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male and/or female subjects between 21 and 55 years of age(inclusive).
Exclusion Criteria:
- Evidence or history of clinically significant disease.
- Evidence or history of urologic disease (benign prostate hyperplasia, recurrent urinary tract infections, urinary retention, etc.).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Treatment A, Cohort 1
|
One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose
One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose
One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose
One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose
one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose
|
|
EXPERIMENTAL: Treatment B, Cohort 2
|
One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose
One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose
One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose
One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose
one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose
|
|
EXPERIMENTAL: Treatment C, Cohort 1
|
One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose
One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose
One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose
One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose
one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose
|
|
EXPERIMENTAL: Treatment D, Cohort 2
|
One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose
One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose
One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose
One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose
one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose
|
|
ACTIVE_COMPARATOR: Treatment E, Cohort 1 and/or Cohort 2
|
One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose
One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose
One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose
One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose
one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)]
Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
|
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
|
|
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
|
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
|
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
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|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
|
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
|
|
Plasma Decay Half-Life (t1/2)
Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
|
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (ACTUAL)
July 1, 2012
Study Completion (ACTUAL)
July 1, 2012
Study Registration Dates
First Submitted
March 27, 2012
First Submitted That Met QC Criteria
March 27, 2012
First Posted (ESTIMATE)
March 29, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
August 19, 2016
Last Update Submitted That Met QC Criteria
August 17, 2016
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Fesoterodine
Other Study ID Numbers
- A0221069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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