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Completed

NCT Number: NCT01140425

Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy Subjects

The purpose of this study is to assess the affect that PF-00232798 has on QT interval. A prolonged QT interval is a risk factor for arrhythmias.

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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 and/or female subjects of non-childbearing potential between the ages of 21 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
  • 12-lead ECG demonstrating QTc >450 msec at screening.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
  • History of orthostatic symptoms or orthostatic hypotension at screening.
  • Pregnant or nursing females; females of childbearing potential.

Treatment and study plan

PF-00232798

Drug

600 mg oral solution once daily x 7 days

Placebo

Drug

Oral solution once daily x 7 days

moxifloxacin

Drug

400 mg tablet single dose

Primary outcomes

  1. QTc, using Fridericia's correction method (QTcF) at each time point of PF-00232798 and placebo on Day 7.

    Time frame: 7 days

Secondary outcomes

  1. QTcF, or any other appropriate correction method at each postdose time point of moxifloxacin on Day 7

    Time frame: 7 days

  2. QTcB or any other appropriate correction method at each postdose time point of PF-00232798 and placebo on Day 7

    Time frame: 7 days

  3. Pharmacokinetic endpoints for PF-00232798 (Tmax, Cmax, Cτ, and AUClast)

    Time frame: 7 days

  4. Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • ViiV Healthcare

Registry information

Official study title

A Phase 1, Randomized, Multiple Dose, Placebo And Active Controlled, 4-Way Crossover Study To Evaluate The Effect Of A Multiple Oral Dose of PF-00232798 On Qt Intervals In Healthy Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 9, 2010
Registry last updated
Dec 23, 2010

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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