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A Study To Investigate The Effect Of Erythromycin On The Pharmacokinetics Of PH-797804

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: PH-797804 (Drug); PH-797804 + erythromycin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


The purpose of this study is to investigate the effect of co-administration with erythromycin on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet formulation.

Clinical Details

Official title: A Phase 1, Randomised, Open Label, Two Sequence, Two Treatment, Two Way Crossover Study to Estimate the Steady-state Effect of Erythromycin on the Single Dose Pharmacokinetics of Ph-797804 in Healthy Subjects

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

Primary outcome:

Maximum Observed Plasma Concentration (Cmax)

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Plasma Decay Half-Life (t1/2)

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]


Minimum age: 21 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- Healthy male subjects and/or healthy female subjects of non-child bearing potential

between the ages of 21 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.

- Body Mass Index (BMI) of 17. 5 to 30. 5 kg/m2; and a total body weight > 50 kg (110

lbs). Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine,

pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

- A positive urine drug screen.

- History of regular alcohol consumption exceeding 21 drinks/week for males.

Locations and Contacts

Pfizer Investigational Site, Singapore 188770, Singapore
Additional Information

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

Starting date: June 2012
Last updated: August 16, 2012

Page last updated: August 23, 2015

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