Bioavailability and Food Effect Study of Two Formulations of PF-06650833

NCT03308110 | Completed Phase 1

• 2 other identifiers: B79210112017-002052-88
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Bioavailability and food effect of 2 formulations of PF-06650833 in healthy volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax

  0-96 hours

• AUClast

  0-96 hours

Secondary Outcomes (3)

• Cmax under high fat meal fed conditions

  0-96 hours

• Pharmacokinetic parameters of PF-06650833 from plasma concentration (if data permits)

  0-96 hours

• AUClast under high fat meal fed conditions

  0-96 hours

Study Arms (1)

Relative Bioavailability Cohort

OTHER

Relative Bioavailability cohort

Drug: PF-06650833

Interventions

PF-06650833 DRUG

Two formulations of PF-006650833

Relative Bioavailability Cohort

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 nonchild bearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
• Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

You may not qualify if:

• Subjects with any of the following characteristics/conditions will not be included in the study:
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• A positive urine drug test.
• History of regular alcohol consumption within 6 months before screening.
• 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).
• Screening supine BP greater than equal to 140 mm Hg (systolic) or more than equal to 90 mm Hg (diastolic), following at least 5 minutes of supine rest.
• Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential;
• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product.
• History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON-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).
• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

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
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: October 12, 2017
• Study Start: September 8, 2017
• Primary Completion: December 8, 2017
• Study Completion: January 11, 2018
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)