Relative Bioavailability and Food Effect Study

Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00827515
• Other study ID #: A6631025
• Status: Withdrawn
• Phase: Phase 1
• First received: January 21, 2009
• Last updated: March 4, 2015
• Start date: February 2009
• Est. completion date: May 2009

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• PH797804
Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fasted state
• PH797804
Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fed state
• PH797804
Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fasted state
• PH797804
Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fed state

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood levels of PH797804 up to 336 hours after dosing in each treatment period		336 hours	No
Secondary	Safety and tolerability of PH797804 in each treatment period up to 336 hours post-dose		336 hours	Yes

External Links

•   To obtain contact information for a study center near you, click here.