NCT02160158

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2014

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

June 6, 2014

Last Update Submit

January 14, 2015

Conditions

Healthy

Keywords

FesoterodineSR3SR4bioavailabilitypharmacokineticssprinkleapplesauce

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    48 hours

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    48 hours

  • Plasma Decay Half-Life (t1/2)

    48 hours

Study Arms (2)

Cohort 1

EXPERIMENTAL
Drug: Fesoterodine ER (fasted)Drug: Fesoterodine SR3 (fasted)Drug: Fesoterodine SR3 (fed)Drug: Fesoterodine ER (fed)Drug: Fesoterodine SR3 (sprinkle)

Cohort 2

EXPERIMENTAL
Drug: Fesoterodine ER (fasted)Drug: Fesoterodine SR4 (fasted)Drug: Fesoterodine SR4 (fed)Drug: Fesoterodine ER (fed)Drug: Fesoterodine SR4 (sprinkle)

Interventions

Fesoterodine ER (fasted)DRUG

Commercial Fesoterodine ER 4 mg (single dose)

Cohort 1
Fesoterodine SR3 (fasted)DRUG

Fesoterodine SR3 4 mg (single dose)

Cohort 1
Fesoterodine SR3 (fed)DRUG

Fesoterodine SR3 4 mg (single dose) with high-fat meal

Cohort 1
Fesoterodine ER (fed)DRUG

Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal

Cohort 1
Fesoterodine SR3 (sprinkle)DRUG

Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce

Cohort 1
Fesoterodine SR4 (fasted)DRUG

Fesoterodine SR4 4 mg (single dose)

Cohort 2
Fesoterodine SR4 (fed)DRUG

Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal

Cohort 2
Fesoterodine SR4 (sprinkle)DRUG

Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce

Cohort 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

MeSH Terms

Interventions

fesoterodine

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    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

June 6, 2014

First Posted

June 10, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 15, 2015

Record last verified: 2015-01

Locations

BE(1)