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Trial record 1 of 1 for:    NCT01566760
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A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01566760
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 27, 2012
First Posted Date  ICMJE March 29, 2012
Last Update Posted Date August 19, 2016
Study Start Date  ICMJE May 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
  • 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. ]
  • 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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2012)
  • 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. ]
  • 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. ]
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Urinary Bladder, Overactive
Intervention  ICMJE
  • Drug: fesoterodine fumarate
    One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose
  • Drug: fesoterodine fumarate
    One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose
  • Drug: fesoterodine fumarate
    One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose
  • Drug: fesoterodine fumarate
    One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose
  • Drug: fesoterodine fumarate
    one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose
Study Arms  ICMJE
  • Experimental: Treatment A, Cohort 1
    Intervention: Drug: fesoterodine fumarate
  • Experimental: Treatment B, Cohort 2
    Intervention: Drug: fesoterodine fumarate
  • Experimental: Treatment C, Cohort 1
    Intervention: Drug: fesoterodine fumarate
  • Experimental: Treatment D, Cohort 2
    Intervention: Drug: fesoterodine fumarate
  • Active Comparator: Treatment E, Cohort 1 and/or Cohort 2
    Intervention: Drug: fesoterodine fumarate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2012)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01566760
Other Study ID Numbers  ICMJE A0221069
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP