- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02419820
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
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
- 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
- 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:
- a healthy adult between 20 and 45 years old at the time of visit for screening
- a person who is able to give written consent
- a person between 50 and 85 kg at the time of visit for screening
- 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
- a person more than hemoglobin 12 g/dL at the time of screening (a woman more than hemoglobin 11 g/dL)
- 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:
- a person with the medical history of gastric ulcer, duodenal ulcer or esophageal ulcer within 90 days from the time of visit for screening
- 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
- 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
- a woman with the medical history of dysfunctional uterine bleeding within a year from the time of visit for screening
- a person with the medical history of epilepsy or convulsion
- a person with the medical history of internal organ transplant
- a person expected to be hard to complete a clinical trial because of surgery or medical procedures planned within a clinical trial period
- 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
- a person with hypersensitivity reaction to a drug or gelatin, or the medical history of clinically significant hypersensitivity reaction
- a person with the history of drug abuse, or with a positive reaction to a drug possible to be abused on urine drug screening
- a person with the medical history of alcohol abuse within two years from the time of visit for screening
- a person who is a smoker, or with a positive reaction on a urine nicotine test conducted at the time of visit for screening
- 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
- a person taking other clinical trial drugs within 90 days from the time of visit for screening
- 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
- a person with a positive reaction to a serum test(hepatitis B test, hepatitis C test, HIV test, syphilis test)
- 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)
- 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:
|
|
Eksperimentell: APD791 20mg single dose
|
Temanogrel
Andre navn:
|
|
Eksperimentell: APD791 40mg single dose
|
Temanogrel
Andre navn:
|
|
Eksperimentell: APD791 10mg
APD791 10mg single dose + Aspirin + Clopidogrel
|
Klopidogrel
Andre navn:
Temanogrel
Andre navn:
Aspirin
Andre navn:
|
|
Eksperimentell: APD791 20mg
APD791 20mg single dose + Aspirin + Clopidogrel
|
Klopidogrel
Andre navn:
Temanogrel
Andre navn:
Aspirin
Andre navn:
|
|
Eksperimentell: APD791 40mg
APD791 40mg single dose + Aspirin + Clopidogrel
|
Klopidogrel
Andre navn:
Temanogrel
Andre navn:
Aspirin
Andre navn:
|
|
Eksperimentell: APD791 80mg
APD791 80mg single dose + Aspirin + Clopidogrel
|
Klopidogrel
Andre navn:
Temanogrel
Andre navn:
Aspirin
Andre navn:
|
|
Eksperimentell: APD791 160mg
APD791 160mg single dose + Aspirin + Clopidogrel
|
Klopidogrel
Andre navn:
Temanogrel
Andre navn:
Aspirin
Andre navn:
|
|
Eksperimentell: APD791 240mg
APD791 240mg single dose + Aspirin + Clopidogrel
|
Klopidogrel
Andre navn:
Temanogrel
Andre navn:
Aspirin
Andre navn:
|
|
Eksperimentell: APD791 320mg
APD791 320mg single dose + Aspirin + Clopidogrel
|
Klopidogrel
Andre navn:
Temanogrel
Andre navn:
Aspirin
Andre navn:
|
|
Placebo komparator: APD791 Placebo
APD791 placebo for single dose + Aspirin + Clopidogrel
|
Klopidogrel
Andre navn:
Temanogrel
Andre navn:
Aspirin
Andre navn:
Placebo for APD791
Andre navn:
|
|
Eksperimentell: APD791 2mg MD
APD791 2mg multiple dose + Aspirin + Clopidogrel
|
Klopidogrel
Andre navn:
Temanogrel
Andre navn:
Aspirin
Andre navn:
|
|
Eksperimentell: APD791 5mg MD
APD791 5mg multiple dose + Aspirin + Clopidogrel
|
Klopidogrel
Andre navn:
Temanogrel
Andre navn:
Aspirin
Andre navn:
|
|
Eksperimentell: APD791 10mg MD
APD791 10mg multiple dose + Aspirin + Clopidogrel
|
Klopidogrel
Andre navn:
Temanogrel
Andre navn:
Aspirin
Andre navn:
|
|
Eksperimentell: APD791 20mg MD
APD791 placebo for multiple dose + Aspirin + Clopidogrel
|
Klopidogrel
Andre navn:
Temanogrel
Andre navn:
Aspirin
Andre navn:
|
|
Placebo komparator: APD791 placebo MD
APD791 placebo for multiple dose + Aspirin + Clopidogrel
|
Klopidogrel
Andre navn:
Temanogrel
Andre navn:
Aspirin
Andre navn:
Placebo for APD791
Andre navn:
|
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.
Sponsor
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
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Myokardiskemi
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Akutt koronarsyndrom
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystemet
- Enzymhemmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Blodplateaggregasjonshemmere
- Syklooksygenase-hemmere
- Antipyretika
- Purinergiske P2Y-reseptorantagonister
- Purinergiske P2-reseptorantagonister
- Purinergiske antagonister
- Purinergiske midler
- Serotoninmidler
- Serotonin 5-HT2-reseptorantagonister
- Serotonin-antagonister
- Aspirin
- Klopidogrel
- APD791
Andre studie-ID-numre
- ID-TMG-102
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. .