Study to Estimate the Relative Bioavailability Compared to Commercial Extended-release Tablet Formulation and the Effects of Food Or Sprinkling on Applesauce for Fesoterodine Sustained-release Beads-in-capsule Formulations in Healthy Adult Volunteers

Open-label, Single-dose, Randomized, Crossover Study To Estimate The Relative Bioavailability Compared To Commercial Extended-release Tablet Formulation And The Effects Of Food Or Sprinkling On Applesauce For Fesoterodine Sustained-release Beads-in-capsule Formulations In Healthy Adult Volunteers

The purpose of this study is to evaluate the relative bioavailability of 2 new bead-in-capsule formulations compared to the commercial extended-release formulation (both fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Fesoterodine ER (fasted); Drug: Fesoterodine SR3 (fasted); Drug: Fesoterodine SR3 (fed); Drug: Fesoterodine ER (fed); Drug: Fesoterodine SR3 (sprinkle); Drug: Fesoterodine SR4 (fasted); Drug: Fesoterodine SR4 (fed); Drug: Fesoterodine SR4 (sprinkle)

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, B-1070
    • Pfizer Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and/or female subjects between the ages of 18 and 55 years; Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

Exclusion Criteria:

• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
• History of uncontrolled narrow angle glaucoma, myasthenia gravis, gastric retention, severe ulcerative colitis and toxic megacolon
• Evidence or history of clinically significant urologic disease [urinary retention, obstructive disturbance of bladder emptying, micturition disturbance, nocturia or pollacisuria (eg, benign prostate hyperplasia, urethral stricture, recurrent urinary tract infections); Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes/day

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1	Drug: Fesoterodine ER (fasted); Commercial Fesoterodine ER 4 mg (single dose); Drug: Fesoterodine SR3 (fasted); Fesoterodine SR3 4 mg (single dose); Drug: Fesoterodine SR3 (fed); Fesoterodine SR3 4 mg (single dose) with high-fat meal; Drug: Fesoterodine ER (fed); Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal; Drug: Fesoterodine SR3 (sprinkle); Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce
Experimental: Cohort 2	Drug: Fesoterodine ER (fasted); Commercial Fesoterodine ER 4 mg (single dose); Drug: Fesoterodine ER (fed); Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal; Drug: Fesoterodine SR4 (fasted); Fesoterodine SR4 4 mg (single dose); Drug: Fesoterodine SR4 (fed); Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal; Drug: Fesoterodine SR4 (sprinkle); Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.	48 hours
Maximum Observed Plasma Concentration (Cmax)		48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	48 hours
Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	48 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)		48 hours

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 6, 2014
• First Submitted That Met QC Criteria: June 6, 2014
• First Posted (Estimate): June 10, 2014

Study Record Updates

• Last Update Posted (Estimate): January 15, 2015
• Last Update Submitted That Met QC Criteria: January 14, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: pharmacokinetics; bioavailability; Fesoterodine; applesauce; SR3; SR4; sprinkle
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Fesoterodine
• Other Study ID Numbers: A0221099; 2014-001248-39 (EudraCT Number)