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

18 maggio 2020 aggiornato da: 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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Effettivo)

15

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06511
        • Pfizer New Haven Clinical Research Unit

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 55 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PF-06650833 Cmax
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Percentage of participants with treatment emergent adverse events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

7 febbraio 2019

Completamento primario (Effettivo)

29 aprile 2019

Completamento dello studio (Effettivo)

29 aprile 2019

Date di iscrizione allo studio

Primo inviato

31 gennaio 2019

Primo inviato che soddisfa i criteri di controllo qualità

31 gennaio 2019

Primo Inserito (Effettivo)

1 febbraio 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 maggio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2020

Ultimo verificato

1 maggio 2020

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • B7921028

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su PF-06650833 alone

3
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