Completed
A Phase 1, Open Label, Single Dose, Bioavailability Study In Healthy Volunteers Comparing PF-05089771 TS Oral Dispersion To PF-05089771 TS Capsule
What is being tested
PF-05089771
+ PF-05089771
Drug
Who is being recruted
Neurologic Manifestations+1
+ Signs and Symptoms
+ Pathological Conditions, Signs and Symptoms
From 18 to 55 Years
+7 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: September 2012
Summary
Principal SponsorPfizer
Last updated: December 12, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 capsule.
Principal SponsorPfizer
Last updated: December 12, 2012
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain
Criteria
1 inclusion criteria required to participate
Healthy male and/or non-childbearing potential female subjects between the ages of 18 and 55 years
6 exclusion criteria prevent from participating
A positive urine drug screen
Any condition possibly affecting drug absorption (eg, gastrectomy)
Evidence or history of clinically significant hematological, renal,endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalOral dispersion TS formulation- fasted
Group II
ExperimentalCapsules TS formulation- fasted
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center