A Study to Evaluate the PF-06700841 Effect on QTc Interval in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-05

Study Completion Date

2019-02-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A phase 1, 6-sequence, 3-period, subject- and investigator blinded and sponsor-open, crossover study in healthy volunteers to evaluate the PF-06700841 effect on QTc interval. Each subject randomized will receive placebo, PF-06700841 200 mg and moxifloxacin (open label) in one of the 6 sequences. Moxifloxacin is positive control to demonstrate the study sensitivity and PF-06700841 effect on QTc will be assessed by concentration-QT analysis

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study To Determine The Effect Of Single-dose PF-04965842 On QTc Interval In Healthy Volunteers Compared With Placebo and Moxifloxacin

NCT03386279

Healthy Volunteers

COMPLETED PHASE1

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

NCT01862887

Healthy

COMPLETED PHASE1

Phase 1 Study to Assess the Effects of EVP-6124 on the QT/QTc Interval in Healthy Subjects

NCT01487135

Healthy Subjects Cardiac Repolarization

COMPLETED PHASE1

A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects

NCT02785770

Healthy

COMPLETED PHASE1

Study to Evaluate the Effect of a Single Oral Dose of MT-7117 on the QT/QTc Interval in Healthy Subjects

NCT05241535

Healthy Subjects

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Seq 1

PF-06700841-\> placebo-\> moxifloxacin

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

a single oral dose of 200 mg PF-06700841

Placebo

Intervention Type DRUG

Placebo matching PF-06700841

moxifloxacin

Intervention Type DRUG

a single oral dose of 400 mg moxifloxacin

Seq 2

PF-06700841-\>moxifloxacin-\>placebo

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

a single oral dose of 200 mg PF-06700841

Placebo

Intervention Type DRUG

Placebo matching PF-06700841

moxifloxacin

Intervention Type DRUG

a single oral dose of 400 mg moxifloxacin

Seq 3

Placebo-\>PF-06700841-\>moxifloxacin

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

a single oral dose of 200 mg PF-06700841

Placebo

Intervention Type DRUG

Placebo matching PF-06700841

moxifloxacin

Intervention Type DRUG

a single oral dose of 400 mg moxifloxacin

Seq 4

Placebo-\>moxifloxacin-\>PF-06700841

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

a single oral dose of 200 mg PF-06700841

Placebo

Intervention Type DRUG

Placebo matching PF-06700841

moxifloxacin

Intervention Type DRUG

a single oral dose of 400 mg moxifloxacin

Seq 5

Moxifloxacin-\>PF-06700841-\>placebo

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

a single oral dose of 200 mg PF-06700841

Placebo

Intervention Type DRUG

Placebo matching PF-06700841

moxifloxacin

Intervention Type DRUG

a single oral dose of 400 mg moxifloxacin

Seq 6

Moxifloxacin-\>placebo-\>PF-06700841

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

a single oral dose of 200 mg PF-06700841

Placebo

Intervention Type DRUG

Placebo matching PF-06700841

moxifloxacin

Intervention Type DRUG

a single oral dose of 400 mg moxifloxacin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-06700841

a single oral dose of 200 mg PF-06700841

Intervention Type DRUG

Placebo

Placebo matching PF-06700841

Intervention Type DRUG

moxifloxacin

a single oral dose of 400 mg moxifloxacin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy female subjects of non-childbearing potential and/or male subjects. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including BP and pulse rate measurement, 12-lead ECG, or clinical laboratory tests.
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb) at screening.
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic (including alcoholic liver disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver diseases), psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing)
* Self-reported history or risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia, congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness, family history of sudden death, and family history of long QT syndrome.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product (whichever is longer)
* Subjects with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a trial involving PF-06700841
* History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON- tuberculosis (TB) Gold test
* History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb)
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing
* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes