A DRUG-DRUG INTERACTION STUDY BETWEEN PF-06650833 AND PF-06651600 FOLLOWING MULTIPLE DOSES IN HEALTHY PARTICIPANTS

NCT03827668

Last updated date
Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

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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

- 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.

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


- 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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Advanced Information
Descriptive Information
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
  • Drug: PF-06650833 alone
    In Period 1, Days 1-5, participants will receive PF-06650833 once daily alone.
  • Drug: PF-06651600 alone
    In Period 2, Days 1-7, participants will receive PF-06651600 once daily alone.
  • Drug: PF-06650833 together with PF-06651600
    In Period 2, Days 8-12, participants will receive PF-06650833 once daily together with PF-06650833 once daily.
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:
  • Drug: PF-06650833 alone
  • Drug: PF-06651600 alone
  • Drug: PF-06650833 together with PF-06651600
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
 (submitted: January 31, 2019)
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:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
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