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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Pulmonary Disease; Lung Disease; Moxifloxacin

Treatments: Drug: PF-00610355; Drug: moxifloxacin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01107054

A7881014

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 4 patient groups, including a placebo group

PF-00610355 450 µg

Experimental group

Description:

An orally inhaled dose of PF-00610355 450 µg

Treatment:

Drug: PF-00610355

Drug: PF-00610355

PF-00610355 1200 µg

Experimental group

Description:

An orally inhaled dose of PF-00610355 1200 µg

Treatment:

Drug: PF-00610355

Drug: PF-00610355

moxifloxacin 400 mg

Active Comparator group

Description:

A single oral dose of moxifloxacin 400 mg on Day 4.

Treatment:

Drug: moxifloxacin

placebo

Placebo Comparator group

Description:

A single oral dose of non-matched placebo on Day 4.

Treatment:

Drug: placebo