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Dose-escalation, Repeated and Single Oral Dosing Study

11. februar 2019 oppdatert av: IlDong Pharmaceutical Co Ltd

Randomized, Double-blind, Placebo-controlled, Dose-escalation, Repeated and Single Oral Dosing Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Temanogrel Co-administered With Aspirin and Clopidogrel

Randomized, Double-blind, Placebo-controlled, Dose-escalation, Repeated and Single Oral Dosing Phase I Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of APD791 (Temanogrel) Co-administered with Aspirin and Clopidogrel.

Studieoversikt

Detaljert beskrivelse

  1. To investigate pharmacokinetic and pharmacodynamic characteristics of Temanogrel when orally co-administered with Aspirin and/or Clopidogrel in healthy subject. a person determined to be suitable for the purpose of this clinical trial by investigator with consideration for the age and the health status of a volunteer is selected
  2. Assess the safety of Temanogrel when orally co-administered with Aspirin and/or Clopidogrel in healthy subjects.

Studietype

Intervensjonell

Registrering (Faktiske)

104

Fase

  • Fase 1

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

20 år til 45 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  1. a healthy adult between 20 and 45 years old at the time of visit for screening
  2. a person who is able to give written consent
  3. a person between 50 and 85 kg at the time of visit for screening
  4. a woman who is negative on a serum hCG test at the time of visit and the day before a trial, and who is not nursing, a woman who agrees on double contraception, medically approved, from the time of visit for screening to 90 days after the last administration of a clinical trial drug, or who had a contraceptive operation no later than 120 days before visit for screening, or who is menopausal, a man who had a contraceptive operation no later than 120 days before visit for screening, or who agrees on double contraception, medically approved, from the time of visit for screening to 90 days after the last administration of a clinical trial drug, and also agree not to donate sperm
  5. a person more than hemoglobin 12 g/dL at the time of screening (a woman more than hemoglobin 11 g/dL)
  6. a person whose vital signs were in the normal range at the time of visit for screening, or who is medically determined not to be clinically significant by an investigator

Exclusion Criteria:

  1. a person with the medical history of gastric ulcer, duodenal ulcer or esophageal ulcer within 90 days from the time of visit for screening
  2. a person with the medical history of gastrointestinal diseases(e.g. Crohn's disease, ulcerative colitis, etc.) or surgery(excluding uncomplicated appendectomy or herniotomy) affecting the absorption of a clinical trial drug
  3. a person with the medical history of blood coagulation disorder or hemorrhagic diseases, or with clinically significant abnormal findings decided by a investigator on blood coagulation test at the time of screening
  4. a woman with the medical history of dysfunctional uterine bleeding within a year from the time of visit for screening
  5. a person with the medical history of epilepsy or convulsion
  6. a person with the medical history of internal organ transplant
  7. a person expected to be hard to complete a clinical trial because of surgery or medical procedures planned within a clinical trial period
  8. a person with the medical history of clinically significant new diseases within 30 days from the time of visit for screening according to investigator's decision
  9. a person with hypersensitivity reaction to a drug or gelatin, or the medical history of clinically significant hypersensitivity reaction
  10. a person with the history of drug abuse, or with a positive reaction to a drug possible to be abused on urine drug screening
  11. a person with the medical history of alcohol abuse within two years from the time of visit for screening
  12. a person who is a smoker, or with a positive reaction on a urine nicotine test conducted at the time of visit for screening
  13. a person who donated whole blood within 60 days or constituents of blood within 30 days, or received a blood transfusion within 30 days from the time of visit for screening
  14. a person taking other clinical trial drugs within 90 days from the time of visit for screening
  15. a person taking a prescription drug within 30 days, or a contraindicated drug or oriental medicine within 14 days from the time of visit for screening
  16. a person with a positive reaction to a serum test(hepatitis B test, hepatitis C test, HIV test, syphilis test)
  17. a person with hepatic enzymes(AST, ALT) more than 2.5 times of the reference upper limit(UNL) or total bilirubin more than 1.5 times of the reference upper limit(UNL) or creatinine more than 1.25 times of the reference upper limit(UNL)
  18. a person expected to be hard to complete a clinical trial due to physical or mental status according to investigator's medical decision at the time of visit for screening

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: APD791 10mg single dose
Temanogrel
Andre navn:
  • Temanogrel
Eksperimentell: APD791 20mg single dose
Temanogrel
Andre navn:
  • Temanogrel
Eksperimentell: APD791 40mg single dose
Temanogrel
Andre navn:
  • Temanogrel
Eksperimentell: APD791 10mg
APD791 10mg single dose + Aspirin + Clopidogrel
Klopidogrel
Andre navn:
  • Plavix
Temanogrel
Andre navn:
  • Temanogrel
Aspirin
Andre navn:
  • Aspirin Protect
Eksperimentell: APD791 20mg
APD791 20mg single dose + Aspirin + Clopidogrel
Klopidogrel
Andre navn:
  • Plavix
Temanogrel
Andre navn:
  • Temanogrel
Aspirin
Andre navn:
  • Aspirin Protect
Eksperimentell: APD791 40mg
APD791 40mg single dose + Aspirin + Clopidogrel
Klopidogrel
Andre navn:
  • Plavix
Temanogrel
Andre navn:
  • Temanogrel
Aspirin
Andre navn:
  • Aspirin Protect
Eksperimentell: APD791 80mg
APD791 80mg single dose + Aspirin + Clopidogrel
Klopidogrel
Andre navn:
  • Plavix
Temanogrel
Andre navn:
  • Temanogrel
Aspirin
Andre navn:
  • Aspirin Protect
Eksperimentell: APD791 160mg
APD791 160mg single dose + Aspirin + Clopidogrel
Klopidogrel
Andre navn:
  • Plavix
Temanogrel
Andre navn:
  • Temanogrel
Aspirin
Andre navn:
  • Aspirin Protect
Eksperimentell: APD791 240mg
APD791 240mg single dose + Aspirin + Clopidogrel
Klopidogrel
Andre navn:
  • Plavix
Temanogrel
Andre navn:
  • Temanogrel
Aspirin
Andre navn:
  • Aspirin Protect
Eksperimentell: APD791 320mg
APD791 320mg single dose + Aspirin + Clopidogrel
Klopidogrel
Andre navn:
  • Plavix
Temanogrel
Andre navn:
  • Temanogrel
Aspirin
Andre navn:
  • Aspirin Protect
Placebo komparator: APD791 Placebo
APD791 placebo for single dose + Aspirin + Clopidogrel
Klopidogrel
Andre navn:
  • Plavix
Temanogrel
Andre navn:
  • Temanogrel
Aspirin
Andre navn:
  • Aspirin Protect
Placebo for APD791
Andre navn:
  • Placebo for Temanogrel
Eksperimentell: APD791 2mg MD
APD791 2mg multiple dose + Aspirin + Clopidogrel
Klopidogrel
Andre navn:
  • Plavix
Temanogrel
Andre navn:
  • Temanogrel
Aspirin
Andre navn:
  • Aspirin Protect
Eksperimentell: APD791 5mg MD
APD791 5mg multiple dose + Aspirin + Clopidogrel
Klopidogrel
Andre navn:
  • Plavix
Temanogrel
Andre navn:
  • Temanogrel
Aspirin
Andre navn:
  • Aspirin Protect
Eksperimentell: APD791 10mg MD
APD791 10mg multiple dose + Aspirin + Clopidogrel
Klopidogrel
Andre navn:
  • Plavix
Temanogrel
Andre navn:
  • Temanogrel
Aspirin
Andre navn:
  • Aspirin Protect
Eksperimentell: APD791 20mg MD
APD791 placebo for multiple dose + Aspirin + Clopidogrel
Klopidogrel
Andre navn:
  • Plavix
Temanogrel
Andre navn:
  • Temanogrel
Aspirin
Andre navn:
  • Aspirin Protect
Placebo komparator: APD791 placebo MD
APD791 placebo for multiple dose + Aspirin + Clopidogrel
Klopidogrel
Andre navn:
  • Plavix
Temanogrel
Andre navn:
  • Temanogrel
Aspirin
Andre navn:
  • Aspirin Protect
Placebo for APD791
Andre navn:
  • Placebo for Temanogrel

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Pharmacokinetics-Cmax
Tidsramme: Day1, Day2, Day3, Day4, Day 7
Day1, Day2, Day3, Day4, Day 7
Pharmacokinetics-Tmax
Tidsramme: Day1, Day2, Day3, Day4, Day 7
Day1, Day2, Day3, Day4, Day 7
Pharmacodynamics-% inhibition of serotonin-stimulated platelet aggregation
Tidsramme: Day1, Day2, Day4, Day7, Day 8
Day1, Day2, Day4, Day7, Day 8
Pharmacodynamics-change of serotonin-stimulated platelet aggregation
Tidsramme: Day1, Day4, Day7
Day1, Day4, Day7
Pharmacodynamics-% inhibition of TRAP-induced platelet aggregation
Tidsramme: Day1, Day4, Day7 of every dose for mutiple dose group and first day for single dose group.
Day1, Day4, Day7 of every dose for mutiple dose group and first day for single dose group.

Sekundære resultatmål

Resultatmål
Tidsramme
adverse event monitoring
Tidsramme: up to post-study visit(8day±2)
up to post-study visit(8day±2)
physical examination
Tidsramme: up to post-study visit(8day±2)
up to post-study visit(8day±2)
vital signs
Tidsramme: up to post-study visit(8day±2)
up to post-study visit(8day±2)
ECG
Tidsramme: up to post-study visit(8day±2)
up to post-study visit(8day±2)
laboratory test
Tidsramme: up to post-study visit(8day±2)
up to post-study visit(8day±2)

Samarbeidspartnere og etterforskere

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

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Gyunseop Bae, M.D., Asan Medical Center

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 (Faktiske)

1. mars 2015

Primær fullføring (Faktiske)

1. april 2016

Studiet fullført (Faktiske)

1. april 2016

Datoer for studieregistrering

Først innsendt

27. januar 2015

Først innsendt som oppfylte QC-kriteriene

16. april 2015

Først lagt ut (Anslag)

17. april 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. februar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. februar 2019

Sist bekreftet

1. februar 2019

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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