- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01862887
A Study to Investigate the Effect of PH-797804 on QTc Interval
August 14, 2013 updated by: Pfizer
A Phase 1, Randomized, Placebo-And Positive-Controlled Crossover Study To Determine The Effect Of A Single-Dose Of PH-797804 On QTc Interval In Healthy Volunteers
The purpose of this study is to investigate the effect of PH-797804 following dosing of a 24 mg oral tablet on the QTc interval
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 14 drinks/week for males.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PH-797804
Subjects will receive a single 24 mg dose in the fed state
|
Tablet, 24 mg, single dose
|
Experimental: Moxifloxacin
Subjects will receive a single 400 mg dose in the fed state
|
Tablet, 400 mg, single dose
|
Experimental: Placebo
Subjects will receive a single placebo dose
|
Tablet, PH-797804 matched placebo, single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QTcF Interval
Time Frame: -1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose
|
QT interval corrected for heart rate using Fredericias correction
|
-1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QTcI Interval
Time Frame: -1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose
|
QT interval using individual heart rate correction
|
-1.5,-1,-0.5,0.5,2,4,5,6,7,8,12,24 hours post-dose
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time Frame: 0,0.5,2,4,5,6,7,8,12,24 hours post-dose
|
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
|
0,0.5,2,4,5,6,7,8,12,24 hours post-dose
|
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 0,0.5,2,4,5,6,7,8,12,24 hours post-dose
|
0,0.5,2,4,5,6,7,8,12,24 hours post-dose
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 0,0.5,2,4,5,6,7,8,12,24 hours post-dose
|
0,0.5,2,4,5,6,7,8,12,24 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
May 22, 2013
First Submitted That Met QC Criteria
May 22, 2013
First Posted (Estimate)
May 27, 2013
Study Record Updates
Last Update Posted (Estimate)
August 15, 2013
Last Update Submitted That Met QC Criteria
August 14, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A6631035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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