- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03827668
A DRUG-DRUG INTERACTION STUDY BETWEEN PF-06650833 AND PF-06651600 FOLLOWING MULTIPLE DOSES IN HEALTHY PARTICIPANTS
18. mai 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
15
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Connecticut
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New Haven, Connecticut, Forente stater, 06511
- Pfizer New Haven Clinical Research Unit
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 55 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Single arm
The study will have only one study group in a fixed-sequence type of design with two periods
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
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PF-06651600 Cmax
Tidsramme: Fold-change from Period 2/Day 7 to Period 2/Day 12
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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
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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)
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From screening until follow-up phone call that takes place 28-35 days after last study dose (total period of approximately 87 days)
|
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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
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At screening; Days -1, 6 in Period 1; and Days -1, 8, 9, 11, 13 in Period 2
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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
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At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2
|
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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
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At screening; Days 1, 6 in Period 1; and Days 1, 8, 9, 12, 13 in Period 2
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
7. februar 2019
Primær fullføring (Faktiske)
29. april 2019
Studiet fullført (Faktiske)
29. april 2019
Datoer for studieregistrering
Først innsendt
31. januar 2019
Først innsendt som oppfylte QC-kriteriene
31. januar 2019
Først lagt ut (Faktiske)
1. februar 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. mai 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. mai 2020
Sist bekreftet
1. mai 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- B7921028
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .