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Completed

NCT Number: NCT01862887

A Study to Investigate the Effect of PH-797804 on QTc Interval

The purpose of this study is to investigate the effect of PH-797804 following dosing of a 24 mg oral tablet on the QTc interval

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

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 18 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 14 drinks/week for males.

Treatment and study plan

PH-797804

Drug

Tablet, 24 mg, single dose

moxifloxacin

Drug

Tablet, 400 mg, single dose

Placebo

Drug

Tablet, PH-797804 matched placebo, single dose

Primary outcomes

  1. QTcF Interval

    Time frame: -1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose

    QT interval corrected for heart rate using Fredericias correction

Secondary outcomes

  1. QTcI Interval

    Time frame: -1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose

    QT interval using individual heart rate correction

  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

    Time frame: 0,0.5,2,4,5,6,7,8,12,24 hours post-dose

    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0,0.5,2,4,5,6,7,8,12,24 hours post-dose

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

    Time frame: 0,0.5,2,4,5,6,7,8,12,24 hours post-dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Placebo-And Positive-Controlled Crossover Study To Determine The Effect Of A Single-Dose Of PH-797804 On QTc Interval In Healthy Volunteers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 27, 2013
Registry last updated
Aug 15, 2013

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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