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

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT03308110
Pfizer
Completed
Bioavailability and Food Effect Study of Two Formulations of PF-06650833

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Bioavailability and Food Effect Study of Two Formulations of PF-06650833
A Phase 1, Single Dose, Open Label, Randomized, 5-period Crossover Study To Evaluate The Relative Bioavailability And Food Effect On New Modified Release Tablet Of Pf-06650833 In Healthy Subjects
Bioavailability and food effect of 2 formulations of PF-06650833 in healthy volunteers.
Not Provided
Interventional
Phase 1
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Healthy
Drug: PF-06650833
Two formulations of PF-006650833
Relative Bioavailability Cohort
Relative Bioavailability cohort
Intervention: Drug: PF-06650833
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
January 2, 2018
December 8, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Belgium
 
 
NCT03308110
B7921011
2017-002052-88 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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