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

NCT01589614 | Completed Phase 1

• 1 other identifier: A6631036
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

PH-797804 6 mg

EXPERIMENTAL

Subjects will receive a single 6 mg dose in the fed state

Drug: PH-797804

PH-797804 6 mg + erythromycin 800 mg

EXPERIMENTAL

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

Drug: PH-797804 + erythromycin

Interventions

PH-797804 DRUG

Tablet, 6mg, single

PH-797804 6 mg

PH-797804 + erythromycin DRUG

PH-797804: tablet, 6mg, single erythromycin: tablet, 400 mg, multiple

PH-797804 6 mg + erythromycin 800 mg

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Singapore, Singapore, 188770, Singapore

Location

Related Links

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

MeSH Terms

Interventions

PH 797804; Erythromycin

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 2, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 17, 2012

Record last verified: 2012-08

Locations

SG (1)