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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140425
• Other study ID #: A7691017
• Status: Completed
• Phase: Phase 1
• First received: June 7, 2010
• Last updated: December 22, 2010
• Start date: July 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-00232798
600 mg oral solution once daily x 7 days
• PF-00232798
300 mg oral solution once daily x 7 days
• Placebo
Oral solution once daily x 7 days
• Moxifloxacin
400 mg tablet single dose

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	ViiV Healthcare

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QTc, using Fridericia's correction method (QTcF) at each time point of PF-00232798 and placebo on Day 7.		7 days	Yes
Secondary	QTcF, or any other appropriate correction method at each postdose time point of moxifloxacin on Day 7		7 days	Yes
Secondary	QTcB or any other appropriate correction method at each postdose time point of PF-00232798 and placebo on Day 7		7 days	Yes
Secondary	Pharmacokinetic endpoints for PF-00232798 (Tmax, Cmax, Ct, and AUClast)		7 days	No
Secondary	Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments		7 days	Yes

External Links

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