A Study Comparing PF-06273340 Immediate Release Tablet, PF-06273340 Modified Release Tablets To PF-06273340 Oral Solution In The Fasted State. This Study Will Also Compare PF-06273340 Modified Release Tablets In Fasted And Fed State

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01706796
First received: October 11, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

The primary purpose of this study is to estimate the relative bioavailability and food effect of PF-06273340 tablets.


Condition Intervention Phase
Healthy
Drug: PF-06273340
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label, Randomized, Single Dose, 5 Period Crossover Relative Bioavailability Study In Healthy Volunteers Evaluating Spray Dried Dispersion (SDD) Immediate Release (IR) PF-06273340 Tablet, Two SDD Modified Release (MR) Matrix Tablets In Comparison With PF-06273340 Oral Solution, Including Preliminary Assessment Of Food Effect

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: up to 48 h post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: up to 48 h post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: up to 48 h post dose ] [ Designated as safety issue: No ]
  • Elimination half life [ Time Frame: up to 48 h post dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: up to 48 h post dose ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: November 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-06273340 Oral Solution Fasted Drug: PF-06273340
Oral solution, single dose, fasted
Experimental: PF-06273340 Immediate Release Tablet Fasted Drug: PF-06273340
Immediate Release Tablet, single dose, fasted
Experimental: PF-06273340 Modified Release (MR1) Tablet Fasted Drug: PF-06273340
Modified Release Tablet (short duration, MR1), single dose, fasted
Experimental: PF-06273340 Modified Release (MR2) Tablet Fasted Drug: PF-06273340
Modified Release Tablet (long duration, MR2), single dose, fasted
Experimental: PF-06273340 Modified Release (MR1) Tablet Fed Drug: PF-06273340
Modified Release Tablet (short duration, MR1), single dose, fed
Experimental: PF-06273340 Modified Release (MR2) Tablet Fed Drug: PF-06273340
Modified Release Tablet (long duration, MR2), single dose, fed

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects of non-child bearing potential, between the ages of 21 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • 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).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
  • 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.
  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
  • Screening supine blood pressure >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest.
  • Evidence or history of orthostatic hypotension.
  • 12-lead ECG demonstrating QTc >450 or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
  • Pregnant or nursing females; females of childbearing potential, including those with tubal ligation.
  • Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of <=1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706796

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01706796     History of Changes
Other Study ID Numbers: B5261003
Study First Received: October 11, 2012
Last Updated: January 23, 2013
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Pfizer:
Pain

Additional relevant MeSH terms:
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014