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Relative Bioavailability and Food Effect Study

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00827515
Pfizer
Withdrawn
Relative Bioavailability and Food Effect Study

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Descriptive Information
Brief Title  ICMJE Relative Bioavailability and Food Effect Study
Official Title  ICMJE 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
Brief SummaryInitial 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
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: One
    Intervention: Drug: PH797804
  • Experimental: Two
    Intervention: Drug: PH797804
  • Experimental: Three
    Intervention: Drug: PH797804
  • Experimental: Four
    Intervention: Drug: PH797804
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 4, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2009)
16
Estimated Study Completion Date  ICMJE May 2009
Estimated Primary Completion DateApril 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location CountriesSingapore
 
Administrative Information
NCT Number  ICMJE NCT00827515
Other Study ID Numbers  ICMJE A6631025
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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