A Study to Investigate the Effect of PH-797804 on QTc Interval

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PH-797804; Drug: Placebo; Drug: Moxifloxacin

• Registration Number: NCT01862887
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-27
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-14
• Last Update Posted: 2013-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PH-797804	PH-797804	Subjects will receive a single 24 mg dose in the fed state
Placebo	Placebo	Subjects will receive a single placebo dose
Moxifloxacin	Moxifloxacin	Subjects will receive a single 400 mg dose in the fed state

Primary Outcome Measures

Name	Time	Method
QTcF Interval	-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

Secondary Outcome Measures

Name	Time	Method
QTcI Interval	-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
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]	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)
Maximum Observed Plasma Concentration (Cmax)	0,0.5,2,4,5,6,7,8,12,24 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0,0.5,2,4,5,6,7,8,12,24 hours post-dose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States