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

10. april 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

24

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Texas
      • San Antonio, Texas, Forente stater, 78209
        • ICON Early Phase Services, LLC Clinical Research Unit

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 55 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: GBT440
GBT440 capsules followed by Caffeine, S-warfarin+vitamin K, Omeprazole, and Midazolam

Hva måler studien?

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

Samarbeidspartnere og etterforskere

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

Sponsor

Global Blood Therapeutics

Etterforskere

  • Studieleder: Carla Washington, PhD, Global Blood Therapeutics

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. september 2015

Primær fullføring (Faktiske)

1. mai 2016

Studiet fullført (Faktiske)

1. mai 2016

Datoer for studieregistrering

Først innsendt

23. september 2015

Først innsendt som oppfylte QC-kriteriene

1. oktober 2015

Først lagt ut (Anslag)

5. oktober 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. april 2017

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GBT440-003

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