A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to determine the cardiovascular effects of PF00610335 in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• Healthy male and female subjects aged 18 to 55 years

• Informed consent document signed by the subject or a legally acceptable representative

• Subjects who are willing and able to comply with the scheduled visits, treatment tests, laboratory tests, and other study procedures

Exclusion Criteria:

• Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic psychiatric, neurologic or allergic disease or clinical findings at screening

• Conditions possibly affecting drug absorption

• 12-lead ECg demonstrating QTc > 450ms or any other clinically significant abnormalities at screen

• Positive urine drug screen

• Hypersensitivity to moxifloxacin or PF00610335

• Unwilling or unable to comply with the lifestyle guidelines in the protocol Treatment with an investigational drug within 3 months or 5 half lives (whichever is longer) preceding the first dose of study medication