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

NCT ID: NCT01140425

Last Updated: 2010-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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PF-00232798 CCR5 QT QTc pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-00232798 supratherapeutic dose

PF-00232798 supratherapeutic dose

Group Type EXPERIMENTAL

PF-00232798

Intervention Type DRUG

600 mg oral solution once daily x 7 days

PF-00232798 therapeutic dose

PF-00232798 therapeutic dose

Group Type EXPERIMENTAL

PF-00232798

Intervention Type DRUG

300 mg oral solution once daily x 7 days

Placebo for PF-00232798

Placebo for PF-00232798

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral solution once daily x 7 days

Moxifloxacin

Moxifloxacin

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

400 mg tablet single dose

Interventions

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PF-00232798

600 mg oral solution once daily x 7 days

Intervention Type DRUG

PF-00232798

300 mg oral solution once daily x 7 days

Intervention Type DRUG

Placebo

Oral solution once daily x 7 days

Intervention Type DRUG

Moxifloxacin

400 mg tablet single dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ViiV Healthcare

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Singapore, , Singapore

Site Status

Countries

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Singapore

Related Links

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Other Identifiers

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A7691017

Identifier Type: -

Identifier Source: org_study_id