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Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects

10. april 2017 opdateret af: Global Blood Therapeutics

A Phase 1, Open-Label Study to Evaluate the Effect of Multiple Doses of GBT440 on the Pharmacokinetics of Probe Substrates for CYP1A2, CYP2C9, CYP2C19, and CYP3A4 in Healthy Subjects

The purpose of this study to evaluate the effect of concomitant administration of GBT440 on caffeine (a CYP1A2 probe substrate), S warfarin (a CYP2C9 probe substrate), omeprazole (a CYP2C19 probe substrate), and midazolam (a CYP3A4 probe substrate) plasma concentrations.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

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
    • Texas
      • San Antonio, Texas, Forenede Stater, 78209
        • ICON Early Phase Services, LLC Clinical Research Unit

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 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 55 years old, inclusive, at screening
  • Male subjects agree to use contraception
  • Willing and able to give written informed consent

Exclusion Criteria:

  • Evidence or history of clinically significant metabolic, allergic, dermatological, hepatic, renal,hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
  • History of hypersensitivity or allergy to drugs, foods, or other substances
  • History or presence of abnormal electrocardiogram or hypertension
  • History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 1 year of screening
  • Participated in another clinical trial of an investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Fixed sequence, 2-periods
An open-label, fixed sequence, 2-period drug interaction study Period 1 Treatment A: Single dose of drug cocktail on Day 1 Period 2 Treatment B: GBT440 on Days 1 through 3 and Treatment C: Single dose of drug cocktail on Day 4 and GBT440 on Days 4 through 7
Medicin: GBT440
GBT440 capsules followed by Caffeine, S-warfarin+vitamin K, Omeprazole, and Midazolam

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Peak plasma concentration(Cmax) for caffeine, S warfarin, omeprazole, and midazolam in plasma
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUCt) for caffeine, S warfarin, omeprazole, and midazolam
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
Area under the plasma concentration time curve from time 0 extrapolated to infinity (AUCinf) for caffeine, S warfarin, omeprazole, and midazolam
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2

Sekundære resultatmål

Resultatmål
Tidsramme
The time that Cmax was observed (tmax) for caffeine, S warfarin, omeprazole, and midazolam in plasma
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
Terminal elimination half-life (t½) for caffeine, S warfarin, omeprazole, and midazolam in plasma
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
Cmax for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
tmax, for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
AUCt for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
AUCinf for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
t1/2 for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
Ratio of metabolite to parent Cmax corrected for molecular weight (Cmax M/P) for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
Ratio of metabolite to parent AUCt corrected for molecular weight (AUCt M/P)for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
Ratio of metabolite to parent AUCinf corrected for molecular weight (AUCinf M/P) for metabolites of caffeine, warfarin, omeprazole, and midazolam in plasma
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
Cmax for GBT440 in whole blood and plasma
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
tmax for GBT440 in whole blood and plasma
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
AUC from time 0 to 24 hours (AUC0-24) (Days 4 and 7) for GBT440 in whole blood and plasma
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
t1/2 (Day7) for GBT440 in whole blood and plasma
Tidsramme: 0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2
0 - 168 hours post dose in Period 1 and 0-408 hours post dose in Period 2

Andre resultatmål

Resultatmål
Tidsramme
Treatment-emergent adverse events (TEAEs) and serious adverse events
Tidsramme: Baseline to Period 2 Day 25
Baseline to Period 2 Day 25
Change in clinical laboratory tests
Tidsramme: Baseline to Period 2 Day 25
Baseline to Period 2 Day 25
Change in physical examination findings
Tidsramme: Baseline to Period 2 Day 25
Baseline to Period 2 Day 25
Change in vital signs
Tidsramme: Baseline to Period 2 Day 25
Baseline to Period 2 Day 25
Change in pulse oximetry findings
Tidsramme: Baseline to Period 2 Day 25
Baseline to Period 2 Day 25
Change in electrocardiograms (ECGs)
Tidsramme: Baseline to Period 2 Day 25
Baseline to Period 2 Day 25

Samarbejdspartnere og efterforskere

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

Sponsor

Global Blood Therapeutics

Efterforskere

  • Studieleder: Carla Washington, PhD, Global Blood Therapeutics

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

1. september 2015

Primær færdiggørelse (Faktiske)

1. maj 2016

Studieafslutning (Faktiske)

1. maj 2016

Datoer for studieregistrering

Først indsendt

23. september 2015

Først indsendt, der opfyldte QC-kriterier

1. oktober 2015

Først opslået (Skøn)

5. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GBT440-003

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Kliniske forsøg med Seglcellesygdom

Kliniske forsøg med GBT440

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