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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Moxifloxacin; Drug: Placebo; Drug: PH-797804

Study type: Interventional

Funder types: Industry

Identifiers

NCT01862887

A6631035

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 3 patient groups

PH-797804

Experimental group

Description:

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

Treatment:

Drug: PH-797804

Moxifloxacin

Experimental group

Description:

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

Treatment:

Drug: Moxifloxacin

Placebo

Experimental group

Description:

Subjects will receive a single placebo dose

Treatment:

Drug: Placebo