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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589614
• Other study ID #: A6631036
• Status: Completed
• Phase: Phase 1
• First received: April 30, 2012
• Last updated: August 16, 2012
• Start date: June 2012
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Singapore Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PH-797804
Tablet, 6mg, single
• PH-797804 + erythromycin
PH-797804: tablet, 6mg, single erythromycin: tablet, 400 mg, multiple

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]		0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose	No

External Links

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