Relative Bioavailability and Food Effect Study

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00827515
First received: January 21, 2009
Last updated: May 18, 2009
Last verified: May 2009

January 21, 2009
May 18, 2009
February 2009
April 2009   (final data collection date for primary outcome measure)
Blood levels of PH797804 up to 336 hours after dosing in each treatment period [ Time Frame: 336 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00827515 on ClinicalTrials.gov Archive Site
Safety and tolerability of PH797804 in each treatment period up to 336 hours post-dose [ Time Frame: 336 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Relative Bioavailability and Food Effect Study
A Phase 1, Randomized, Open-Label, Single Dose, 4-Way Crossover Study In Healthy Volunteers To Assess The Relative Bioavailability Of The Oral Powder In Capsule (PIC) And An Immediate Release (IR) Film-Coated Tablet Of PH-797804 In The Fed And Fasted State

Initial studies have used a powder in capsule formulation of PH797804. In future studies an immediate release tablet will be used. The purpose of this study is to compare blood levels of PH797804 following an oral dose of the powder in capsule formulation and the tablet formulation. In addition the effect of food blood levels of PH797804 will be investigated

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Pain
  • Drug: PH797804
    Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fasted state
  • Drug: PH797804
    Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fed state
  • Drug: PH797804
    Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fasted state
  • Drug: PH797804
    Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fed state
  • Experimental: One
    Intervention: Drug: PH797804
  • Experimental: Two
    Intervention: Drug: PH797804
  • Experimental: Three
    Intervention: Drug: PH797804
  • Experimental: Four
    Intervention: Drug: PH797804
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
16
May 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or female subjects aged 21 to 55 years
  • Healthy is defined as no clinical 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
  • Willing to use acceptable methods of contraception as outlined in the study protocol
  • Body mass index between 18 to 30 kg/m2
  • Subjects who are willing and able to comply with the scheduled visits, treatment plan and other study procedures

Exclusion Criteria:

  • Subjects with evidence or history of clinically significant disease
  • Pregnant or nursing females
  • Females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to the first dose until day 15 of period 4
  • Subjects with conditions possibly affecting drug absorption (eg gastrectomy)
  • A positive approved immunoassay/ELISA blood test for TB
  • Subjects with a history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men
  • Subjects who have use prescription or nonprescription drugs, vitamins and/or dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
  • Subjects who have been administered medications capable of inducing hepatic enzyme metabolism (eg barbiturates, rifampin, carbamazepine, phenytoin or primidone) within 14 days (or 5 half-lives of the inducing agent, whichever is longer) of day 1 or within 28 days of administration of St John's wort
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00827515
A6631025
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2009

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