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A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954

6. august 2020 oppdatert av: Takeda

A Phase 1, Open-Label, Parallel Group Trial to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single Intravenous Dose of TAK-954

The purpose of this study is to evaluate the effect of varying degrees of renal function on the PK of TAK-954 following single-dose IV administration and to investigate the impact of hemodialysis on the PK of single IV doses of TAK-954.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

The drug being tested in this study is called TAK-954. This study will evaluate the effect of varying degrees of renal function on the PK of TAK-954 following single-dose IV administration and to investigate the impact of hemodialysis on the PK of single IV doses of TAK-954.

The study will enroll approximately up to 40 participants. Participants will be enrolled in one of the 5 treatment groups based on their renal impairment which will be determined based on Cockcroft and Gault (CG) equation as follows:

  • Group A TAK-954 0.2 mg: Healthy Participants
  • Group B TAK-954 0.2 mg: Mild Renal Impairment
  • Group C TAK-954 0.2 mg: Moderate Renal Impairment
  • Group D TAK-954 0.2 mg: Severe Renal Impairment or End-stage Renal Disease (ESRD) Without Hemodialysis
  • Group E TAK-954 0.2 mg: End-stage Renal Disease (ESRD) With Hemodialysis

All participants in groups A to D will receive a single dose of TAK-954 and two single doses in Group E.

Enrollment in Group B (Mild) and Group E (ESRD requiring dialysis) will be based on assessment of safety and available PK data from Group C and Group D respectively.

This multi-center trial will be conducted in Czech Republic and Hungary. The overall time to participate in this study is approximately 8 weeks. Participants in Groups A to D will remain confined to clinic for 3 days. For both treatments, participants in Group E requiring dialysis will remain confined to clinic for 3 days. All participants will make a final visit to the clinic 10-14 days after receiving their last dose for a follow-up assessment.

Studietype

Intervensjonell

Registrering (Faktiske)

32

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiesteder

      • Hradec Kralove, Tsjekkia, 500 05
        • Fakultni nemocnice Hradec Kralove
    • Praha
      • Praha 7, Praha, Tsjekkia, 170 00
        • PRA CZ, s.r.o
      • Budapest, Ungarn, 1077
        • PRA Magyarország Kft.
      • Budapest, Ungarn, 1115
        • Szent Imre Egyetemi Oktatokorhaz Belgyogyazati Szakmak Matrix Intezet

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 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. All participants: Male and female participants (non-childbearing potential) who are aged 18 to 75 years, inclusive, with a body mass index (BMI) between 18 to 35 kilogram per square meter (kg/m^2).
  2. Group A: As much as possible, the healthy participants with normal renal function (creatinine clearance [CLcr] greater than or equal to [>=] 90 milliliter per minute [mL/min]) should be comparable to participants with renal impairment with respect to median age and weight (approximately 50 percent [%] of healthy participants on each side of the median age and weight of currently enrolled renally-impaired participants grouped together), sex, and race. This will be decided by the investigators in discussion with Takeda.
  3. Groups B to E: Participants who have stable RI, defined as no clinically significant change in disease status, as documented by the participant's most recent CLcr assessment; serum creatinine must not vary more than approximately 30% from Screening to Day -1 to confirm stable disease. Participants should also be in good health commensurate with their renal status.

    • Group B: Participants with mild RI (CLcr 60 to less than [<] 90 mL/min).
    • Group C: Participants with moderate RI (CLcr 30 to <60 mL/min).
    • Group D: Participants with severe RI or ESRD but not requiring dialysis (CLcr <30 mL/min).
    • Group E: Participants with ESRD requiring dialysis (<15 mL/min requiring hemodialysis at least 3 times/week, and having been on the same dialysis treatment regimen for at least 1 month before trial entry).
  4. Participants should be on a stable drug regimen defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) before dosing with TAK-954.

Exclusion Criteria:

  1. All participants:

    • Are renal allograft recipients within 1 year of screening.
    • Have a history of gastrointestinal (GI) motility disorder or intestinal obstruction.
    • Have urinary incontinence without catheterization.
  2. Group A: Participants who, in the discretion of the investigator, have a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases will be excluded from the trial.
  3. Groups B to E:

    • Receive dialysis other than intermittent dialysis (except Group E).
    • Have renal disease secondary to hepatic disease (hepatorenal syndrome).
    • At the discretion of the investigators, have any significant hepatic, cardiac, or pulmonary disease or participants who are clinically nephrotic.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Group A TAK-954 0.2 mg: Healthy Participants
Participants with normal renal function receive TAK-954 0.2 milligram (mg), infusion, intravenously in fasted state, once on Day 1 of a 6-day period.
TAK-954 intravenøs infusjon.
Eksperimentell: Group B TAK-954 0.2 mg: Mild Renal Impairment
Participants receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period.
TAK-954 intravenøs infusjon.
Eksperimentell: Group C TAK-954 0.2 mg: Moderate Renal Impairment
Participants receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period.
TAK-954 intravenøs infusjon.
Eksperimentell: Group D TAK-954 0.2 mg: Severe Renal Impairment
Participants without hemodialysis or End-stage Renal Disease (ESRD) receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 6-day period.
TAK-954 intravenøs infusjon.
Eksperimentell: Group E TAK-954 0.2 mg: End-stage Renal Disease (ESRD)
Participants with hemodialysis receive TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 4-day period followed by a minimum 13-day washout period, further followed by TAK-954 0.2 mg, infusion, intravenously in fasted state, once on Day 1 of a 4-day period.
TAK-954 intravenøs infusjon.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Groups A, C and D; Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free)
Tidsramme: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Groups A, C and D; AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for TAK-954 (Free and Total)
Tidsramme: Day 1 pre-infusion and at multiple time points (up to 72 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 72 hours) post-infusion
Groups A, C and D; AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 (Free and Total)
Tidsramme: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Groups A, C and D; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 (Free and Total)
Tidsramme: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion
Groups A, C and D; Ae: Amount of TAK-954 Excreted in Urine
Tidsramme: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 1
Tidsramme: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 2
Tidsramme: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Groups A, C and D; Fe: Fraction of TAK-954 Excreted in Urine
Tidsramme: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 1
Tidsramme: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 2
Tidsramme: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Groups A, C and D; CLR: Renal Clearance for TAK-954
Tidsramme: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; CLR: Renal Clearance for TAK-954 in Period 1
Tidsramme: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; CLR: Renal Clearance for TAK-954 in Period 2
Tidsramme: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion
Group E; CLD: Clearance of Dialysate for TAK-954 in Period 2
Tidsramme: Day 1 pre-infusion and at multiple time points (up to 4 hours) post-infusion
Day 1 pre-infusion and at multiple time points (up to 4 hours) post-infusion

Samarbeidspartnere og etterforskere

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

Sponsor

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)

21. november 2017

Primær fullføring (Faktiske)

9. august 2019

Studiet fullført (Faktiske)

9. august 2019

Datoer for studieregistrering

Først innsendt

25. september 2017

Først innsendt som oppfylte QC-kriteriene

25. september 2017

Først lagt ut (Faktiske)

28. september 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. august 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. august 2020

Sist bekreftet

1. august 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TAK-954-1007
  • U1111-1196-9206 (Registeridentifikator: WHO)
  • 2017-000715-16 (EudraCT-nummer)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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