Relative Bioavailability and Food Effect Study

NCT00827515 | Withdrawn Phase 1

• 1 other identifier: A6631025
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pain

Keywords

Relative Bioavailability Effect of food

Outcome Measures

Primary Outcomes (1)

• Blood levels of PH797804 up to 336 hours after dosing in each treatment period

  336 hours

Secondary Outcomes (1)

• Safety and tolerability of PH797804 in each treatment period up to 336 hours post-dose

  336 hours

Study Arms (4)

One

EXPERIMENTAL

Drug: PH797804

Two

EXPERIMENTAL

Drug: PH797804

Three

EXPERIMENTAL

Drug: PH797804

Four

EXPERIMENTAL

Drug: PH797804

Interventions

PH797804 DRUG

Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fasted state

One

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Pain

Interventions

PH 797804

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 5, 2015

Record last verified: 2015-03