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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PH-797804 + erythromycin; Drug: PH-797804

• Registration Number: NCT01589614
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-04-30
• Study First Posted: 2012-05-02
• Study Start: 2012-06
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-16
• Last Update Posted: 2012-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PH-797804 6 mg + erythromycin 800 mg	PH-797804 + erythromycin	Subjects will receive multiple 800 mg doses of erythromycin and a single 6 mg dose of PH-797804 in the fed state
PH-797804 6 mg	PH-797804	Subjects will receive a single 6 mg dose in the fed state

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
Plasma Decay Half-Life (t1/2)	0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]	0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore