Overview

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