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Completed

NCT Number: NCT01589614

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

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.

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Key information

Conditions

Healthy

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PH-797804

Drug

Tablet, 6mg, single

PH-797804 + erythromycin

Drug

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

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose

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

    Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose

  4. Plasma Decay Half-Life (t1/2)

    Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose

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

    Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 2, 2012
Registry last updated
Aug 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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