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

Healthy Clinical Trial

Official title:

A PHASE 1, RANDOMIZED, PLACEBO-AND POSITIVE-CONTROLLED CROSSOVER STUDY TO DETERMINE THE EFFECT OF SINGLE-DOSE PF-06700841 ON QTC INTERVAL IN HEALTHY VOLUNTEERS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656952
• Other study ID #: B7931019
• Secondary ID: 2018-001932-23
• Status: Completed
• Phase: Phase 1
• Start date: September 5, 2018
• Est. completion date: February 6, 2019

Study information

• Verified date: February 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 6, 2019
• Est. primary completion date: February 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06700841
a single oral dose of 200 mg PF-06700841
• Placebo
Placebo matching PF-06700841
• moxifloxacin
a single oral dose of 400 mg moxifloxacin

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QTc change from baseline following PF-06700841 treatment	QTc change from baseline at geometric mean of maximum concentrations observed after single doses of 200 mg PF-06700841 and maximum concentrations expected at lower doses of 30 and 60 mg.	0 to 48 hours post-dose
Secondary	QTc change from baseline following moxifloxacin treatment	QTc change from baseline at 3 hours (Tmax) after a single dose of 400 mg moxifloxacin administration	0-48 hours post-dose

External Links

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