Clinical Study to Evaluate Blood Concentrations of PF-06700841 After Oral Dose as Different Formulations
NCT03765554
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- Healthy male, and female participants between the ages of 18 and 55 years at the time of screening, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Key
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- Have or have had clinically significant infections within the past 3 months prior to
the first dose of investigational product (eg, those requiring hospitalization or
parenteral antibiotics, or as judged by the Investigator), evidence of any infection
within the past 7 days prior to the first dose of investigational product, herpes
simplex within 12 weeks or history of disseminated herpes simplex infection,
symptomatic herpes zoster or recurrent (>1 episode) or disseminated herpes zoster.
- 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). As an exception, a positive hepatitis B
surface antibody (HepBsAb) finding as a result of participant vaccination is
permissible.
- History of tuberculosis or active or latent or inadequately treated infection,
positive QuantiFERON tuberculosis (TB) Gold test.
- Previous administration 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 used in this study (whichever is longer).
- Female participants who are pregnant or wish to become pregnant; breastfeeding
females.
- Males/Females of childbearing potential who are unwilling or unable to use a highly
effective method of contraception as outlined in this protocol for the duration of the
study and for at least 28 days after the last dose of investigational product.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 56 days prior to dosing.
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| Descriptive Information | |||||||
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| Brief Title ICMJE | Clinical Study to Evaluate Blood Concentrations of PF-06700841 After Oral Dose as Different Formulations | ||||||
| Official Title ICMJE | A PHASE 1, OPEN-LABEL STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE PHARMACOKINETICS OF PF-06700841 FOLLOWING SINGLE ORAL ADMINISTRATION OF MODIFIED RELEASE TABLETS COMPARED TO IMMEDIATE RELEASE TABLETS UNDER FASTED CONDITIONS | ||||||
| Brief Summary | PF-06700841 is a dual Tyrosine kinase 2 (TYK2) Janus kinase 1 (JAK1) inhibitor that is being developed for oral treatment of adult patients with Inflammatory Bowel Disease (IBD).This open-label study will evaluate the pharmacokinetics of PF-06700841 following single oral doses of immediate release (IR) and modified release (MR) tablets in healthy, adult participants under fasted conditions. This is an open label, single dose, randomized, 2 period, 2- sequence crossover study in a single cohort of approximately 8 (minimum 6) healthy participants. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 1 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science | ||||||
| Condition ICMJE | Healthy Participants | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 8 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | April 3, 2019 | ||||||
| Actual Primary Completion Date | April 3, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 55 Years (Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Belgium | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03765554 | ||||||
| Other Study ID Numbers ICMJE | B7931010 2018-003512-41 ( EudraCT Number ) | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||||
| Verification Date | May 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||