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

NCT01862887 | Completed Phase 1

• 1 other identifier: A6631035
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• QTcF Interval

  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 Outcomes (4)

• QTcI Interval

  -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)]

  0,0.5,2,4,5,6,7,8,12,24 hours post-dose

• 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

Study Arms (3)

PH-797804

EXPERIMENTAL

Subjects will receive a single 24 mg dose in the fed state

Drug: PH-797804

Moxifloxacin

EXPERIMENTAL

Subjects will receive a single 400 mg dose in the fed state

Drug: Moxifloxacin

Placebo

EXPERIMENTAL

Subjects will receive a single placebo dose

Drug: Placebo

Interventions

PH-797804 DRUG

Tablet, 24 mg, single dose

PH-797804

Moxifloxacin DRUG

Tablet, 400 mg, single dose

Moxifloxacin

Placebo DRUG

Tablet, PH-797804 matched placebo, single dose

Placebo

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

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

MeSH Terms

Interventions

PH 797804; Moxifloxacin

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: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 27, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 15, 2013

Record last verified: 2013-08

Locations

US (1)