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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 agosto 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

32

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

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

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 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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.

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: Altro
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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 infusione endovenosa.
Sperimentale: 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 infusione endovenosa.
Sperimentale: 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 infusione endovenosa.
Sperimentale: 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 infusione endovenosa.
Sperimentale: 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 infusione endovenosa.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Groups A, C and D; Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

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

Sponsor

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)

21 novembre 2017

Completamento primario (Effettivo)

9 agosto 2019

Completamento dello studio (Effettivo)

9 agosto 2019

Date di iscrizione allo studio

Primo inviato

25 settembre 2017

Primo inviato che soddisfa i criteri di controllo qualità

25 settembre 2017

Primo Inserito (Effettivo)

28 settembre 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 agosto 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 agosto 2020

Ultimo verificato

1 agosto 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TAK-954-1007
  • U1111-1196-9206 (Identificatore di registro: WHO)
  • 2017-000715-16 (Numero EudraCT)

Piano per i dati dei singoli partecipanti (IPD)

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

Descrizione del piano IPD

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.

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 .

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