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A Study of Baricitinib and Ciclosporin in Healthy Participants

15. mai 2017 oppdatert av: Eli Lilly and Company

A Study to Investigate the Effect of Ciclosporin on the Pharmacokinetics of Baricitinib (LY3009104) in Healthy Subjects

The purpose of this study is to determine the effects of ciclosporin on the amount of baricitinib that is absorbed into the blood stream and the time it takes to remove baricitinib from the body. The study will also look at how well-tolerated and safe baricitinib is, when given alone and in combination with ciclosporin. Side effects will be documented. The study will last approximately 6 days from the first dose to the end of the study (not including screening or follow-up).

Studieoversikt

Status

Fullført

Studietype

Intervensjonell

Registrering (Faktiske)

18

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • West Yorkshire
      • Leeds, West Yorkshire, Storbritannia, LS2 9LH
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

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 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Male participants: agree to use 2 reliable methods of birth control with female partners of childbearing potential during the study and for at least 3 months following the last dose of study drug
  • Female participants: women not of childbearing potential due to surgical sterilization confirmed by medical history, or menopause
  • Have a body mass index of 18.0 to 29.0 kilograms per meter squared (kg/m^2), inclusive
  • Have clinical laboratory test results within the normal reference range
  • Have normal renal function
  • Have normal blood pressure and pulse rate

Exclusion Criteria:

  • Are currently enrolled in a clinical trial involving a study drug or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research
  • Have completed or discontinued within the last 90 days from a clinical trial involving a study drug
  • Are participants who have previously completed or withdrawn from this study or any other study investigating baricitinib, and have previously received baricitinib
  • Have known allergies to baricitinib, ciclosporin, related compounds, or any components of the baricitinib or ciclosporin formulations, or history of significant atopy
  • Have an abnormality in the 12-lead electrocardiogram (ECG)
  • Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Have a current or recent history of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
  • Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose
  • Have an absolute neutrophil count (ANC) less than 2 × 10^9 cells/liter(L) [2000 cells/microliter (μL)] at screening or day prior to first dose of study drug
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Show evidence of hepatitis C infection and/or positive hepatitis C antibody
  • Show evidence of hepatitis B infection and/or positive hepatitis B surface antigen
  • Have a history of active tuberculosis within the last 5 years
  • Are women who are lactating or pregnant
  • Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study
  • Intend to use over-the-counter or prescription medication (including salicylate drugs) and/or herbal supplements within 14 days prior to dosing and during the study or intended use of vitamin supplements from Day 1 until discharge from the Clinical Research Unit (CRU)
  • Have consumed or intend to consume grapefruit, Seville oranges, or products containing these fruits within 7 days prior to the first dose and until discharge from the CRU
  • Have donated or lost blood of more than 500 milliliters (mL) within the last 3 months
  • Have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females), or are unwilling to stop alcohol consumption from 48 hours prior to the first dose until discharge from the CRU at the end of Period 2
  • History of, in the opinion of the investigator, excessive methylxanthine use within the previous 6 months, such as greater than (>) 6 cups of coffee (or equivalent) per day
  • Currently smoke more than 10 cigarettes per day

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: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Baricitinib
Enkel oral dose på 4 milligram (mg) baricitinib på dag 1
Administreres oralt
Andre navn:
  • LY3009104
Eksperimentell: Baricitinib + Ciclosporin
Single oral dose of 4 mg baricitinib co-administered with a single oral dose of 600 mg ciclosporin on Day 4
Administreres oralt
Andre navn:
  • LY3009104
Administered orally

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib
Tidsramme: Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose
Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose
PK: Area Under the Concentration Curve From Time Zero to Infinity [AUC (0-∞)] of Baricitinib
Tidsramme: Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose
Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib
Tidsramme: Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose
Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

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

1. oktober 2013

Primær fullføring (Faktiske)

1. desember 2013

Studiet fullført (Faktiske)

1. desember 2013

Datoer for studieregistrering

Først innsendt

18. oktober 2013

Først innsendt som oppfylte QC-kriteriene

18. oktober 2013

Først lagt ut (Anslag)

23. oktober 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. juni 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. mai 2017

Sist bekreftet

1. mai 2017

Mer informasjon

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. .

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