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Study to Compare Pharmacokinetics & Pharmacodynamics of Warfarin & Esmolol in the Absence & Presence of MEDI0382

24. april 2018 opdateret af: MedImmune LLC

A Phase 1, Open-label Study to Compare the Pharmacokinetics and Pharmacodynamics of Warfarin and Esmolol in the Absence and Presence of MEDI0382 in Healthy Subjects

A Phase 1 study to evaluate the effect of MEDI0382 on PK and PD of warfarin and esmolol in healthy subjects.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a Phase 1 open label, one-sequence, crossover study to evaluate the effect of MEDI0382 on PK and PD of warfarin and esmolol in healthy subjects. The safety and tolerability of MEDI0382 in combination with warfarin and esmolol will also be evaluated. Following screening, the study consists of 2 5-day inpatient stays followed by outpatient visits.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Florida
      • Daytona Beach, Florida, Forenede Stater, 32117
        • Research Site

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 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:.

  • Healthy volunteers aged ≥ 18 to 45 years
  • BMI between 18 -30 kg/m2
  • Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception

Exclusion Criteria:

  • Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
  • Receipt of investigational product as part of a clinical study or a GLP-1 analogue containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening.
  • Concurrent participation in another study of any kind
  • Severe allergy/hypersensitivity to any of the proposed study treatments or excipients.
  • History or presence of gastrointestinal (GI), hepatic, or renal disease or any other conditions known to interfere with absorption, distribution, metabolism or excretion of drugs.
  • Impaired renal function is defined as estimated glomerular filtration rate (eGFR) < 60 mL/minute/1.73 m2 at screening.
  • Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of screening.
  • History of hemophilia, von Willebrand's disease, lupus anticoagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MEDI0382
All participants will receive MEDI0382.
Biologisk: MEDI0382
All participants will receive MEDI0382
Aktiv komparator: Warfarin
All participants will receive Warfarin
Medicin: Warfarin
All participants will receive Warfarin
Aktiv komparator: Esmolol
All participants will receive Esmolol
Medicin: Esmolol
All participants will receive Esmolol

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum international normalized ratio (INRmax)
Tidsramme: Days 2-8 and Days 27-33
To assess the INR max in the absence and presence of Warfarin on a steady state MEDI0382
Days 2-8 and Days 27-33
Change in heart rate from resting after a 9-minute excercise treadmill test (Bruce Protocol, first 3 stages)
Tidsramme: Days 1 and 26
To assess the effects of MEDI0382 on the hear rate-lowering effect of esmolol during treadmill test.
Days 1 and 26
Maximum international normalized ratio (INRmax)
Tidsramme: Days 2-8 and Days 27-33
To assess the AUC INR in the absence and presence of Warfarin on a steady state MEDI0382
Days 2-8 and Days 27-33

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PK(AUC) of R-Warfarin and S-Warfarin
Tidsramme: Days 2 and 27
To assess AUC of R-warfarin and S-warfarin in the presence and absence of steady state MEDI0382
Days 2 and 27
PK (Cmax) of R-Warfarin and S-Warfarin
Tidsramme: Days 2 and 27
To assess Cmax of R-warfarin and S-warfarin in the presence and absence of steady state MEDI0382
Days 2 and 27
Number of patients with Adverse Events (AEs)
Tidsramme: 33 Days
To assess the adverse events as a criteria of safety and tolerability variables.
33 Days
12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals
Tidsramme: Day 1, Day 8, Day 13, and Day 18
To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.
Day 1, Day 8, Day 13, and Day 18
Anti-drug antibody titer incidence
Tidsramme: Days 1 and 33
To evaluate the safety and tolerability of multiple doses of MEDI0382 in conjunction with Warfarin and Esmolol.
Days 1 and 33
Clinical laboratory assessments (hematology)
Tidsramme: Days 1 and 33
To assess hematology as a criteria of safety and tolerability variables..
Days 1 and 33
Vital signs (systolic and diastolic blood pressure)
Tidsramme: Days 1-8, Days 12 and 13, Days 25-33
To assess the vital signs as a criteria of safety and tolerability variables
Days 1-8, Days 12 and 13, Days 25-33
Vital signs (pulse rate and respiratory rate
Tidsramme: Days 1-8, Days 12 and 13, Days 25-33
To assess the vital signs as a criteria of safety and tolerability variables
Days 1-8, Days 12 and 13, Days 25-33
Clinical laboratory assessments (serum chemistry)
Tidsramme: Day -1, Day 8, Day 17, Day 25 and Day 33
To assess clinical chemistry as a criteria of safety and tolerability variables.
Day -1, Day 8, Day 17, Day 25 and Day 33
Clinical laboratory assessment (urinalysis)
Tidsramme: Day -1
To assess urinalysis as a criteria of safety and tolerability variables.
Day -1

Samarbejdspartnere og efterforskere

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

Sponsor

MedImmune LLC

Efterforskere

  • Studieleder: Armando Flor, MedImmune LLC

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)

27. november 2017

Primær færdiggørelse (Faktiske)

9. april 2018

Studieafslutning (Faktiske)

9. april 2018

Datoer for studieregistrering

Først indsendt

16. oktober 2017

Først indsendt, der opfyldte QC-kriterier

17. november 2017

Først opslået (Faktiske)

20. november 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. april 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. april 2018

Sidst verificeret

1. april 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D5670C00009

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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