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

NCT03656952 | Completed Phase 1 FDA Drug

• 2 other identifiers: B79310192018-001932-23
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy

Keywords

PF-06700841; QT effect; concentration-QTc analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• QTc change from baseline following moxifloxacin treatment

  0-48 hours post-dose

Study Arms (6)

Seq 1

EXPERIMENTAL

PF-06700841-\> placebo-\> moxifloxacin

Drug: PF-06700841; Drug: Placebo; Drug: moxifloxacin

Seq 2

EXPERIMENTAL

PF-06700841-\>moxifloxacin-\>placebo

Drug: PF-06700841; Drug: Placebo; Drug: moxifloxacin

Seq 3

EXPERIMENTAL

Placebo-\>PF-06700841-\>moxifloxacin

Drug: PF-06700841; Drug: Placebo; Drug: moxifloxacin

Seq 4

EXPERIMENTAL

Placebo-\>moxifloxacin-\>PF-06700841

Drug: PF-06700841; Drug: Placebo; Drug: moxifloxacin

Seq 5

EXPERIMENTAL

Moxifloxacin-\>PF-06700841-\>placebo

Drug: PF-06700841; Drug: Placebo; Drug: moxifloxacin

Seq 6

EXPERIMENTAL

Moxifloxacin-\>placebo-\>PF-06700841

Drug: PF-06700841; Drug: Placebo; Drug: moxifloxacin

Interventions

PF-06700841 DRUG

a single oral dose of 200 mg PF-06700841

Seq 1; Seq 2; Seq 3; Seq 4; Seq 5; Seq 6

Placebo DRUG

Placebo matching PF-06700841

Seq 1; Seq 2; Seq 3; Seq 4; Seq 5; Seq 6

moxifloxacin DRUG

a single oral dose of 400 mg moxifloxacin

Seq 1; Seq 2; Seq 3; Seq 4; Seq 5; Seq 6

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Publications (1)

• Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31.

  PMID: 36045513 DERIVED

Related 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.

MeSH Terms

Interventions

PF-06700841; 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: August 30, 2018
• First Posted: September 4, 2018
• Study Start: September 5, 2018
• Primary Completion: February 6, 2019
• Study Completion: February 6, 2019
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)