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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-00232798; Drug: Placebo; Drug: Moxifloxacin

• Registration Number: NCT01140425
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-09
• Study Start: 2010-07
• Status Verified: 2010-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2010-12-22
• Last Update Posted: 2010-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-00232798 therapeutic dose	PF-00232798	PF-00232798 therapeutic dose
Placebo for PF-00232798	Placebo	Placebo for PF-00232798
Moxifloxacin	Moxifloxacin	Moxifloxacin
PF-00232798 supratherapeutic dose	PF-00232798	PF-00232798 supratherapeutic dose

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
QTcF, or any other appropriate correction method at each postdose time point of moxifloxacin 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
QTcB or any other appropriate correction method at each postdose time point of PF-00232798 and placebo on Day 7	7 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore