Study to Evaluate Pharmacokinetics of A Modified Release Formulation of PF-06650833 in Healthy Subjects

NCT02609139 | Completed Phase 1

• 2 other identifiers: B7921004IRAK4 MR PK Study
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, open-label, single-dose, within-cohort randomized, 2-way crossover study to evaluate the PK of orally administered PF-06650833 modified release tablets under fasted and high fat meal fed conditions in healthy subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Plasma pharmacokinetic parameters of PF-06650833

  Maximum plasma concentration (Cmax) of PF-06650833

  Baseline to up to Day 14 (0 to +1) postdose

• Plasma pharmacokinetic parameters of PF-06650833

  Area under the plasma concentration versus time curve from time zero to the time of the last quantifiable concentration (AUClast) of PF-06650833

  Baseline to up to Day 14 (0 to +1) postdose

• Plasma pharmacokinetic parameters of PF-06650833

  Area under the plasma concentration versus time curve from time zero extrapolated to infinite time (AUCinf) of PF-06650833 (if data permit)

  Baseline to up to Day 14 (0 to +1) postdose

• Plasma pharmacokinetic parameters of PF-06650833

  Dose-normalized maximum plasma Cmax (Cmax(dn)) of PF-06650833

  Baseline to up to Day 14 (0 to +1) postdose

• Plasma pharmacokinetic parameters of PF-06650833

  Dose-normalized area under the plasma concentration versus time curve from time zero to the time of the last quantitfiable concentration (AUClast(dn)) of PF-06650833

  Baseline to up to Day 14 (0 to +1) postdose

• Plasma pharmacokinetic parameters of PF-06650833 (if data permit)

  Dose-normalized area under the plasma concentration versus time curve from time zero extrapolated to infinite time (AUCinf(dn)) of PF-06650833 (if data permit)

  Baseline to up to Day 14 (0 to +1) postdose

Secondary Outcomes (10)

• Plasma pharmacokinetic parameters of PF-06650833

  Baseline to up to Day 14 (0 to +1) postdose

• Plasma pharmacokinetic parameters of PF-06650833

  Baseline to up to Day 14 (0 to +1) postdose

• Plasma pharmacokinetic parameters of PF-06650833

  Baseline to up to Day 14 (0 to +1) postdose

• Plasma pharmacokinetic parameters of PF-06650833

  Baseline to up to Day 14 (0 to +1) postdose

• Plasma pharmacokinetic parameters of PF-06650833

  Baseline to up to Day 14 (0 to +1) postdose

Study Arms (6)

<=400mg Modified Release Tablets, Fasted

EXPERIMENTAL

Up to 400 mg PF-06650833 modified release tablets administered under fasted conditions

Drug: PF-06650833

100mg Modified Release Tablets, Fasted

EXPERIMENTAL

100 mg PF-06650833 modified release tablets administered under fasted conditions

Drug: PF-06650833

20mg Modified Release Tablets, Fasted

EXPERIMENTAL

20 mg PF-06650833 modified release tablets administered under fasted conditions

Drug: PF-06650833

<= 400mg Modified Release Tablets, Fed

EXPERIMENTAL

Up to 400 mg PF-06650833 modified release tablets administered with high fat meal food intake

Drug: PF-06650833

100mg Modifed Release Tablets, Fed

EXPERIMENTAL

100 mg PF-06650833 modified release tablets administered with high fat meal food intake

Drug: PF-06650833

20mg Modified Release Tablets, Fed

EXPERIMENTAL

20 mg PF-06650833 modified release tablets administered with high fat meal food intake

Drug: PF-06650833

Interventions

PF-06650833 DRUG

Up to 400mg modified release tablets administered under fasted conditions

<=400mg Modified Release Tablets, Fasted

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, between the ages of 18 and 55 years
• BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
• Personally signed and dated Informed Consent
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• Clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
• Any condition possibly affecting drug absorption
• Positive urine drug screen.
• Heavy smokers
• History of regular heavy alcohol consumption within 6 months of Screening.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives
• Screening supine blood pressure \<=100 mm Hg (systolic) or\<=50 mm Hg (diastolic) or\>=140 mm Hg (systolic) or \>=90 mm Hg (diastolic), following at least 5 minutes of supine rest.
• Screening pulse (HR) \>100 bpm after at least 5 minutes of rest.
• Single supine 12 lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec at Screening.
• Abnormal chest X ray
• History of TB or active or latent or inadequately treated infection, positive Quantiferon TB test.
• History of hepatitis or positive testing for human HIV,HepBsAg, HepBc Ab or HCVAb
• Any medical history of disease \[ie, Gilbert's disease\] that has the potential to cause a rise in total bilirubin over the ULN
• Clinical laboratory abnormalities including:
• Creatine kinase \>1.2 X ULN;

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Links

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

MeSH Terms

Interventions

1-(((2S,3S,4S)-3-ethyl-4-fluoro-5-oxopyrrolidin-2-yl)methoxy)-7-methoxyisoquinoline-6-carboxamide

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 20, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 9, 2016

Record last verified: 2016-05

Locations

US (1)