A DRUG-DRUG INTERACTION STUDY BETWEEN PF-06650833 AND PF-06651600 FOLLOWING MULTIPLE DOSES IN HEALTHY PARTICIPANTS
NCT03827668
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
- Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD)
- Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, including blood pressure (BP) and pulse rate measurement, temperature, 12-lead ECG, and 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 lb).
- Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological,
dermatological, 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, cholecystectomy).
- Known immunodeficiency disorder, including positive serology for human
immunodeficiency virus (HIV) at screening, or a first degree relative with a
hereditary immunodeficiency.
- Infection with hepatitis B or hepatitis C viruses according to protocol-specific
testing algorithm.
- Participants with any of the protocol-listed acute or chronic infections or infection
history.
- History of febrile illness within 5 days prior to the first dose of investigational
product (in both Periods).
- History of any lymphoproliferative disorder such as Epstein Barr Virus (EBV) related
lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and
symptoms suggestive of current lymphatic or lymphoid disease.
- Participants have a known present or a history of malignancy other than a successfully
treated or excised non metastatic basal cell or squamous cell cancer of the skin or
cervical carcinoma in situ.
- Benign ethnic (cyclic) neutropenia.
- Having received any live (attenuated) vaccines within 6 weeks prior to the first dose
of investigational product.
- 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 participant inappropriate for entry into
this study.
- Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 half-lives (whichever is longer) prior to the first dose of
investigational product.
- Previous administration of an investigational drug within 30 days (or as determined by
the local requirement) or 5 half-lives (whichever is longer) preceding the first dose
of investigational product used in this study.
- Known participation in a clinical trial of PF-06650833 or PF-06651600.
- A positive urine drug test at screening or admission.
- Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least
5 minutes of supine rest.
- Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may
affect participant safety or interpretation of study results.
- Participants with any of the protocol-listed abnormalities in clinical laboratory
tests at screening, as assessed by the study-specific laboratory and confirmed by a
single repeat test, if deemed necessary.
- Have evidence of untreated or inadequately treated active or latent Mycobacterium
tuberculosis (TB) infection.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening.
- Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
- Have a history of major organ transplant or hematopoietic stem cell/marrow transplant.
Skin grafts are allowed.
- Systemic therapy with any of the medications that are CYP3A4 inhibitors within 7 days
or 5 half-lives (whichever is longer) or CYP3A4 inducers within 28 days or 5
half-lives (whichever is longer) prior to the first dose of the trial medication.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Unwilling or unable to comply with the Lifestyle Considerations criteria of the
protocol.
- Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
Pfizer employees, including their family members, directly involved in the conduct of
the study.
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Descriptive Information | |||||
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Brief Title ICMJE | A DRUG-DRUG INTERACTION STUDY BETWEEN PF-06650833 AND PF-06651600 FOLLOWING MULTIPLE DOSES IN HEALTHY PARTICIPANTS | ||||
Official Title ICMJE | A PHASE I, OPEN LABEL, FIXED SEQUENCE STUDY TO EVALUATE THE STEADY STATE PHARMACOKINETIC DRUG-DRUG INTERACTION BETWEEN PF-06650833 AND PF-06651600 IN HEALTHY ADULT PARTICIPANTS | ||||
Brief Summary | The purpose of this study is to evaluate the potential pharmacokinetic (PK) drug-drug interaction (DDI) between PF-06650833 and PF-06651600 in healthy adult participants. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: This is a Phase I, open label, fixed sequence study. The study will consist of 2 periods in a single fixed sequence. In Period 1, participants will receive PF-06650833 once daily on Days 1-5 and PF-06650833 PK will be assessed for 24 hours following Day 5 dosing. Participants will be discharged on Day 6 after completion of study related activities. There will be a washout period of at least 7 days between last dosing in Period 1 and first dosing in Period 2. In Period 2, participants will receive PF-06651600 once daily alone on Days 1-7, and PF-06651600 once daily together with PF-06650833 once daily on Days 8-12. PF-06651600 PK will be assessed for 24 hours following Day 7 dosing, while PK for both PF-06651600 and PF-06650833 will be assessed for 24 hours following Day 12 dosing. Across both periods few additional pre-dose (trough) PK samples will be collected. Participants will remain in the unit up to Day 13 when they will be discharged after completion of study related activities. Masking: None (Open Label)Primary Purpose: Basic Science | ||||
Condition ICMJE | Healthy | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Single arm
The study will have only one study group in a fixed-sequence type of design with two periods Interventions:
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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 | 15 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | April 29, 2019 | ||||
Actual Primary Completion Date | April 29, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
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 | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03827668 | ||||
Other Study ID Numbers ICMJE | B7921028 | ||||
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 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |