ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- 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
- 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
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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 Summary | 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 | |||
| Detailed Description | Not 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 |
| |||
| Study Arms ICMJE |
| |||
| 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 | 0 | |||
| Original Estimated Enrollment ICMJE | 16 | |||
| Estimated Study Completion Date ICMJE | May 2009 | |||
| Estimated Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 Countries | Singapore | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00827515 | |||
| Other Study ID Numbers ICMJE | A6631025 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||