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Dose-escalation, Repeated and Single Oral Dosing Study

11. februar 2019 opdateret af: 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.

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

104

Fase

  • Fase 1

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

20 år til 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: APD791 10mg single dose
Temanogrel
Andre navne:
  • Temanogrel
Eksperimentel: APD791 20mg single dose
Temanogrel
Andre navne:
  • Temanogrel
Eksperimentel: APD791 40mg single dose
Temanogrel
Andre navne:
  • Temanogrel
Eksperimentel: APD791 10mg
APD791 10mg single dose + Aspirin + Clopidogrel
Clopidogrel
Andre navne:
  • Plavix
Temanogrel
Andre navne:
  • Temanogrel
Aspirin
Andre navne:
  • Aspirin Protect
Eksperimentel: APD791 20mg
APD791 20mg single dose + Aspirin + Clopidogrel
Clopidogrel
Andre navne:
  • Plavix
Temanogrel
Andre navne:
  • Temanogrel
Aspirin
Andre navne:
  • Aspirin Protect
Eksperimentel: APD791 40mg
APD791 40mg single dose + Aspirin + Clopidogrel
Clopidogrel
Andre navne:
  • Plavix
Temanogrel
Andre navne:
  • Temanogrel
Aspirin
Andre navne:
  • Aspirin Protect
Eksperimentel: APD791 80mg
APD791 80mg single dose + Aspirin + Clopidogrel
Clopidogrel
Andre navne:
  • Plavix
Temanogrel
Andre navne:
  • Temanogrel
Aspirin
Andre navne:
  • Aspirin Protect
Eksperimentel: APD791 160mg
APD791 160mg single dose + Aspirin + Clopidogrel
Clopidogrel
Andre navne:
  • Plavix
Temanogrel
Andre navne:
  • Temanogrel
Aspirin
Andre navne:
  • Aspirin Protect
Eksperimentel: APD791 240mg
APD791 240mg single dose + Aspirin + Clopidogrel
Clopidogrel
Andre navne:
  • Plavix
Temanogrel
Andre navne:
  • Temanogrel
Aspirin
Andre navne:
  • Aspirin Protect
Eksperimentel: APD791 320mg
APD791 320mg single dose + Aspirin + Clopidogrel
Clopidogrel
Andre navne:
  • Plavix
Temanogrel
Andre navne:
  • Temanogrel
Aspirin
Andre navne:
  • Aspirin Protect
Placebo komparator: APD791 Placebo
APD791 placebo for single dose + Aspirin + Clopidogrel
Clopidogrel
Andre navne:
  • Plavix
Temanogrel
Andre navne:
  • Temanogrel
Aspirin
Andre navne:
  • Aspirin Protect
Placebo for APD791
Andre navne:
  • Placebo for Temanogrel
Eksperimentel: APD791 2mg MD
APD791 2mg multiple dose + Aspirin + Clopidogrel
Clopidogrel
Andre navne:
  • Plavix
Temanogrel
Andre navne:
  • Temanogrel
Aspirin
Andre navne:
  • Aspirin Protect
Eksperimentel: APD791 5mg MD
APD791 5mg multiple dose + Aspirin + Clopidogrel
Clopidogrel
Andre navne:
  • Plavix
Temanogrel
Andre navne:
  • Temanogrel
Aspirin
Andre navne:
  • Aspirin Protect
Eksperimentel: APD791 10mg MD
APD791 10mg multiple dose + Aspirin + Clopidogrel
Clopidogrel
Andre navne:
  • Plavix
Temanogrel
Andre navne:
  • Temanogrel
Aspirin
Andre navne:
  • Aspirin Protect
Eksperimentel: APD791 20mg MD
APD791 placebo for multiple dose + Aspirin + Clopidogrel
Clopidogrel
Andre navne:
  • Plavix
Temanogrel
Andre navne:
  • Temanogrel
Aspirin
Andre navne:
  • Aspirin Protect
Placebo komparator: APD791 placebo MD
APD791 placebo for multiple dose + Aspirin + Clopidogrel
Clopidogrel
Andre navne:
  • Plavix
Temanogrel
Andre navne:
  • Temanogrel
Aspirin
Andre navne:
  • Aspirin Protect
Placebo for APD791
Andre navne:
  • Placebo for Temanogrel

Hvad måler undersøgelsen?

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)

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Gyunseop Bae, M.D., Asan Medical Center

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)

1. marts 2015

Primær færdiggørelse (Faktiske)

1. april 2016

Studieafslutning (Faktiske)

1. april 2016

Datoer for studieregistrering

Først indsendt

27. januar 2015

Først indsendt, der opfyldte QC-kriterier

16. april 2015

Først opslået (Skøn)

17. april 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Akut koronarsyndrom

Kliniske forsøg med Clopidogrel

Abonner