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

18. maj 2020 opdateret af: Pfizer

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

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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06511
        • Pfizer New Haven Clinical Research Unit

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Single arm
The study will have only one study group in a fixed-sequence type of design with two periods
In Period 1, Days 1-5, participants will receive PF-06650833 once daily alone.
In Period 2, Days 1-7, participants will receive PF-06651600 once daily alone.
In Period 2, Days 8-12, participants will receive PF-06650833 once daily together with PF-06650833 once daily.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PF-06650833 Cmax
Tidsramme: Fold-change from Period 1/Day 5 to Period 2/Day 12
Maximum observed concentration (Cmax) derived from plasma
Fold-change from Period 1/Day 5 to Period 2/Day 12
PF-06650833 AUCtau
Tidsramme: Fold-change from Period 1/Day 5 to Period 2/Day 12
Area under the plasma concentration-time profile derived from plasma from time 0 to time tau, the dosing interval (AUCtau), where tau=24 for QD dosing.
Fold-change from Period 1/Day 5 to Period 2/Day 12
PF-06651600 Cmax
Tidsramme: Fold-change from Period 2/Day 7 to Period 2/Day 12
Maximum observed concentration (Cmax) derived from plasma
Fold-change from Period 2/Day 7 to Period 2/Day 12
PF-06651600 AUCtau
Tidsramme: Fold-change from Period 2/Day 7 to Period 2/Day 12
Area under the plasma concentration-time profile derived from plasma from time 0 to time tau, the dosing interval (AUCtau), where tau=24 for QD dosing.
Fold-change from Period 2/Day 7 to Period 2/Day 12

Sekundære resultatmål

Resultatmål
Tidsramme
Percentage of participants with treatment emergent adverse events
Tidsramme: From screening until follow-up phone call that takes place 28-35 days after last study dose (total period of approximately 87 days)
From screening until follow-up phone call that takes place 28-35 days after last study dose (total period of approximately 87 days)
Percentage of participants with clinical laboratory test results above/below certain threshold
Tidsramme: At screening; Days -1, 6 in Period 1; and Days -1, 8, 9, 11, 13 in Period 2
At screening; Days -1, 6 in Period 1; and Days -1, 8, 9, 11, 13 in Period 2
Percentage of participants with vital signs above/below certain threshold
Tidsramme: At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2
At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2
Percentage of participants with 12-lead electrocardiogram (ECG) results above/below certain threshold
Tidsramme: At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2
At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. februar 2019

Primær færdiggørelse (Faktiske)

29. april 2019

Studieafslutning (Faktiske)

29. april 2019

Datoer for studieregistrering

Først indsendt

31. januar 2019

Først indsendt, der opfyldte QC-kriterier

31. januar 2019

Først opslået (Faktiske)

1. februar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2020

Sidst verificeret

1. maj 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • B7921028

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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/data_requests.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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