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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01140425

Enrollment

Registered

2010-06-09

Start date

2010-07-31

Completion date

2010-12-31

Last updated

2010-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

PF-00232798, CCR5, QT, QTc, pharmacokinetics

Brief summary

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.

Interventions

DRUGPF-00232798

600 mg oral solution once daily x 7 days

DRUGPlacebo

Oral solution once daily x 7 days

DRUGMoxifloxacin

400 mg tablet single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
QTcF, or any other appropriate correction method at each postdose time point of moxifloxacin on Day 7	7 days
QTcB or any other appropriate correction method at each postdose time point of PF-00232798 and placebo on Day 7	7 days
Pharmacokinetic endpoints for PF-00232798 (Tmax, Cmax, Cτ, and AUClast)	7 days
Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments	7 days

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026