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

NCT01107054 | Completed Phase 1

• 1 other identifier: A7881014
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Disease; Lung Disease; Moxifloxacin

Keywords

QTC

Outcome Measures

Primary Outcomes (1)

• To assess whether multiple dose administration of PF00610335 has the potential to affect QTc in healthy volunteers

  24 hours

Secondary Outcomes (2)

• 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

Study Arms (4)

PF-00610355 450 µg

EXPERIMENTAL

An orally inhaled dose of PF-00610355 450 µg

Drug: PF-00610355

PF-00610355 1200 µg

EXPERIMENTAL

An orally inhaled dose of PF-00610355 1200 µg

Drug: PF-00610355

moxifloxacin 400 mg

ACTIVE COMPARATOR

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

Drug: moxifloxacin

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

PF-00610355 DRUG

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

PF-00610355 450 µg

moxifloxacin DRUG

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

moxifloxacin 400 mg

placebo DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Lung Diseases

Interventions

N-((4'-hydroxybiphenyl-3-yl)methyl)-2-(3-(2-((-2-hydroxy-2-(4-hydroxy-3-((methylsulfonyl)amino)phenyl)ethyl)amino)-2-methylpropyl)phenyl)acetamide; Moxifloxacin

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 20, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 13, 2011

Record last verified: 2011-01

Locations

BE (1)