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This study has been withdrawn prior to enrollment.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
  Purpose

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


Condition Intervention Phase
Pain
Drug: PH797804
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Blood levels of PH797804 up to 336 hours after dosing in each treatment period [ Time Frame: 336 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of PH797804 in each treatment period up to 336 hours post-dose [ Time Frame: 336 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: February 2009
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One Drug: PH797804
Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fasted state
Experimental: Two Drug: PH797804
Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fed state
Experimental: Three Drug: PH797804
Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fasted state
Experimental: Four Drug: PH797804
Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fed state

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827515

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00827515     History of Changes
Other Study ID Numbers: A6631025
Study First Received: January 21, 2009
Last Updated: May 18, 2009
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Pfizer:
Relative Bioavailability Effect of food

ClinicalTrials.gov processed this record on April 16, 2014