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A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers

14. oktober 2019 opdateret af: Hoffmann-La Roche

A Single-Center, Non-Randomized, Open-Label, One-Sequence, Two-Period Within-Subject Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Multiple Doses of Balovaptan in Healthy Volunteers

This study was a non-randomized, open-label, one-sequence, two-period within-subject study to investigate the effect of CYP3A inhibition on the PK of balovaptan in healthy male and female volunteers using itraconazole as a CYP3A inhibitor. The study was conducted at 1 site in the Netherlands.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Holland
      • Groningen, Holland, 9728 NZ
        • Pra International Group B.V

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy male and female subjects. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, urinalysis, and serology.
  • Body Mass Index of 18 to 30 kg/m2, inclusive.
  • For women of childbearing potential: agreement to use at least 2 acceptable contraceptive methods during the treatment period and for 90 days after the last dose of study drug.
  • For men: agreement to use contraceptive measures, and agreement to refrain from donating sperm until 90 days after the last dose of study drug.

Exclusion Criteria:

  • Female subjects who are pregnant or lactating.
  • Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Balovaptan + Itraconzole
Dosing in Period 1 was separated by at least a 7 day washout period before dosing starts in Period 2. Participants received the study drugs in 2 periods over a total of 37 days.
Medicin: Balovaptan

In Period 1, balovaptan was administered orally once daily (qd) on Days 1 to 10.

In Period 2, balovaptan was administered qd on Days 6 to 20.

Medicin: Itraconazole
In Period 2, 200 mg itraconzole was administered bid for 4 days and qd on Days 5-20, approximately 12 hours apart. On Days 6-20, 200 mg itraconazole was administered qd.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum Plasma Concentration (Cmax) for Balovaptan
Tidsramme: Day 10 of Period 1, Day 10 and Day 15 of Period 2
Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.
Day 10 of Period 1, Day 10 and Day 15 of Period 2
Maximum Plasma Concentration (Cmax) for M2 Metabolite (as Applicable)
Tidsramme: Day 10 of Period 1, Day 10 and Day 15 of Period 2
Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.
Day 10 of Period 1, Day 10 and Day 15 of Period 2
Maximum Plasma Concentration (Cmax) for M3 Metabolite
Tidsramme: Day 10 of Period 1, Day 10 and Day 15 of Period 2
Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.
Day 10 of Period 1, Day 10 and Day 15 of Period 2
Area Under the Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for Balovaptan
Tidsramme: Day 10 of Period 1, Day 10 and Day 15 of Period 2
Day 10 of Period 1, Day 10 and Day 15 of Period 2
Area Under the Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for M2 Metabolite (as Applicable)
Tidsramme: Day 10 of Period 1, Day 10 and Day 15 of Period 2
Day 10 of Period 1, Day 10 and Day 15 of Period 2
Area Under the Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for M3 Metabolite
Tidsramme: Day 10 of Period 1, Day 10 and Day 15 of Period 2
Day 10 of Period 1, Day 10 and Day 15 of Period 2
Time to Maximum Observed Plasma Concentration (Tmax) for Balovaptan
Tidsramme: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Day 10 of Period 1; Day 10 and Day 15 of Period 2
Time to Maximum Observed Plasma Concentration (Tmax) for M2 Metabolite (as Applicable)
Tidsramme: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Day 10 of Period 1; Day 10 and Day 15 of Period 2
Time to Maximum Observed Plasma Concentration (Tmax) for M3 Metabolite
Tidsramme: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Day 10 of Period 1; Day 10 and Day 15 of Period 2

Sekundære resultatmål

Resultatmål
Tidsramme
Procentdel af deltagere med uønskede hændelser
Tidsramme: Op til 21 dage efter dosis
Op til 21 dage efter dosis
Trough Plasma Concentration (Ctrough) for Balovaptan
Tidsramme: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Day 10 of Period 1; Day 10 and Day 15 of Period 2
Trough Plasma Concentration (Ctrough) for M2 Metabolite (as Applicable)
Tidsramme: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Day 10 of Period 1; Day 10 and Day 15 of Period 2
Trough Plasma Concentration (Ctrough) for M3 Metabolite
Tidsramme: Day 10 of Period 1; Day 10 and Day 15 of Period 2
Day 10 of Period 1; Day 10 and Day 15 of Period 2
Time to Steady State for Balovaptan
Tidsramme: Days 1, 3, 5, 8, 9, 10 in Period 1 and Days 1, 3, 5, 8, 9, 10, 13, 14, 15 in Period 2
Days 1, 3, 5, 8, 9, 10 in Period 1 and Days 1, 3, 5, 8, 9, 10, 13, 14, 15 in Period 2

Samarbejdspartnere og efterforskere

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

Sponsor

Hoffmann-La Roche

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

10. juli 2018

Primær færdiggørelse (Faktiske)

9. november 2018

Studieafslutning (Faktiske)

9. november 2018

Datoer for studieregistrering

Først indsendt

26. juni 2018

Først indsendt, der opfyldte QC-kriterier

26. juni 2018

Først opslået (Faktiske)

9. juli 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • WP40609
  • 2018-001454-10 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

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