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Study to Investigate if the Uptake of Ticagrelor Into the Body Differs Depending on Method of Administration.

17. september 2013 oppdatert av: AstraZeneca

An Open-label, Randomised, 3-period, 3-treatment, Crossover, Single-centre, Single-dose, Bioavailability Study With Alternative Methods of Administration of Crushed Ticagrelor Tablets, 90 mg, Compared to Whole Ticagrelor Tablets, 90 mg, in Healthy Volunteer

Study to investigate if the uptake of Ticagrelor into the body differs depending on method of administration.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Study to evaluate the bioavailability of the crushed ticagrelor tablets when administered orally or through nasogastric tubes compared to whole ticagrelor tablets given orally

Studietype

Intervensjonell

Registrering (Faktiske)

36

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiesteder

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 50 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Healthy male and female volunteers aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venepuncture
  • Have a body mass index between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg (110 pounds [lbs]) and no more than 100 kg (220 lbs).
  • Provision of signed and dated, written informed consent prior to any study specific procedures

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
  • History of haemophilia, von Willebrand's disease, lupus anticoagulant or other diseases/syndromes that can either alter or increase the propensity for bleeding
  • A personal history of vascular abnormalities including aneurysms; a personal history of severe haemorrhage, haematemesis, melena, haemoptysis, severe epistaxis, severe thrombocytopenia, intracranial haemorrhage; or rectal bleeding within 3 months prior to the screeening visit; or history suggestive of peptic ulcer disease
  • History of frequent and/or significant nose bleed or clinically significant non traumatic bleed, bruise/haematoma or any other clinically significant bleeding risk, as judged by the Investigator

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: A
Ticagrelor 90 mg as a whole tablet
Legemiddel: Ticagrelor 90 mg whole tablet
Ticagrelor 90 mg whole tablet administered as a single oral dose
Eksperimentell: B
Ticagrelor 90 mg tablet crushed and suspended in water
Legemiddel: Ticagrelor 90 mg tablet crushed
Ticagrelor 90 mg crushed and suspended in water
Eksperimentell: C
Dispersed ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the the stomach
Legemiddel: Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube
Dispersed 90 mg ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the stomach

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Description of the pharmacokinetic(PK) profile in terms of plasma concentration-time curve (AUC) of ticagrelor
Tidsramme: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of AUC of the active metabolite of ticagrelor
Tidsramme: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of maximum plasma concentration (Cmax) of ticagrelor
Tidsramme: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
Description of the pharmacokinetic(PK) profile in terms of Cmax of the active metabolite of ticagrelor
Tidsramme: PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose
PK samples will be collected pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours post-dose

Sekundære resultatmål

Resultatmål
Tidsramme
Description of the safety profile in terms of adverse events (AE)
Tidsramme: From first dose through to the follow-up visit.
From first dose through to the follow-up visit.
Description of the safety profile in terms of laboratory variables
Tidsramme: Safety labs at screening, Day -1, Day 3 (48 hours after treatment) and follow-up
Safety labs at screening, Day -1, Day 3 (48 hours after treatment) and follow-up
Description of the safety profile in terms of vital signs
Tidsramme: Vital signs at screening, pre-dose, 1 h, 3, 6, 12 and 24 hours post-dose, Day 3 for all treatment periods and follow-up
Vital signs at screening, pre-dose, 1 h, 3, 6, 12 and 24 hours post-dose, Day 3 for all treatment periods and follow-up
Description of the safety profile in terms of physical examination findings
Tidsramme: Physical examination at screening, pre-dose, Day 3 and follow-up
Physical examination at screening, pre-dose, Day 3 and follow-up
Description of the safety profile in terms of Electrocardiogram (ECG)
Tidsramme: ECGs at screening, Day 3 and follow-up
ECGs at screening, Day 3 and follow-up

Samarbeidspartnere og etterforskere

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

Sponsor

AstraZeneca

Etterforskere

  • Studieleder: Judith Hsia, MD, Astrazeneca, Wilmington, US
  • Studiestol: Mirjana Kujacic, MD, AstraZeneca Mölndal, Sweden
  • Hovedetterforsker: Saeed Kahn, MBBS, Quintiles London, United Kingdom

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. juli 2013

Primær fullføring (Faktiske)

1. september 2013

Studiet fullført (Faktiske)

1. september 2013

Datoer for studieregistrering

Først innsendt

25. juni 2013

Først innsendt som oppfylte QC-kriteriene

25. juni 2013

Først lagt ut (Anslag)

27. juni 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

18. september 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. september 2013

Sist bekreftet

1. september 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D5130C00076

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