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

A Double Blind, Randomized, Multiple Dose, Placebo And Active Controlled 4-Way Crossover Study To Investigate The Effects Of Inhaled PF-00610355 On QT/QTC Interval In Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01107054

Enrollment

Registered

2010-04-20

Start date

2010-06-30

Completion date

2010-12-31

Last updated

2011-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Disease, Moxifloxacin, Pulmonary Disease

Keywords

QTC

Brief summary

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

Interventions

DRUGPF-00610355

An orally inhaled dose of PF-00610355 450 µg on days 1 to 4

DRUGmoxifloxacin

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To assess whether multiple dose administration of PF00610335 has the potential to affect QTc in healthy volunteers	24 hours

Secondary

Measure	Time frame
To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers	24 hours
To asses the the relationship between plasma concentrations of PF00610335 and its effects, if any on the QTc interval	24 hours

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026