Dose-escalation, Repeated and Single Oral Dosing Study
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
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 1
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: APD791 10mg single dose
|
Temanogrel
Andre navne:
|
|
Eksperimentel: APD791 20mg single dose
|
Temanogrel
Andre navne:
|
|
Eksperimentel: APD791 40mg single dose
|
Temanogrel
Andre navne:
|
|
Eksperimentel: APD791 10mg
APD791 10mg single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andre navne:
Temanogrel
Andre navne:
Aspirin
Andre navne:
|
|
Eksperimentel: APD791 20mg
APD791 20mg single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andre navne:
Temanogrel
Andre navne:
Aspirin
Andre navne:
|
|
Eksperimentel: APD791 40mg
APD791 40mg single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andre navne:
Temanogrel
Andre navne:
Aspirin
Andre navne:
|
|
Eksperimentel: APD791 80mg
APD791 80mg single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andre navne:
Temanogrel
Andre navne:
Aspirin
Andre navne:
|
|
Eksperimentel: APD791 160mg
APD791 160mg single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andre navne:
Temanogrel
Andre navne:
Aspirin
Andre navne:
|
|
Eksperimentel: APD791 240mg
APD791 240mg single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andre navne:
Temanogrel
Andre navne:
Aspirin
Andre navne:
|
|
Eksperimentel: APD791 320mg
APD791 320mg single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andre navne:
Temanogrel
Andre navne:
Aspirin
Andre navne:
|
|
Placebo komparator: APD791 Placebo
APD791 placebo for single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andre navne:
Temanogrel
Andre navne:
Aspirin
Andre navne:
Placebo for APD791
Andre navne:
|
|
Eksperimentel: APD791 2mg MD
APD791 2mg multiple dose + Aspirin + Clopidogrel
|
Clopidogrel
Andre navne:
Temanogrel
Andre navne:
Aspirin
Andre navne:
|
|
Eksperimentel: APD791 5mg MD
APD791 5mg multiple dose + Aspirin + Clopidogrel
|
Clopidogrel
Andre navne:
Temanogrel
Andre navne:
Aspirin
Andre navne:
|
|
Eksperimentel: APD791 10mg MD
APD791 10mg multiple dose + Aspirin + Clopidogrel
|
Clopidogrel
Andre navne:
Temanogrel
Andre navne:
Aspirin
Andre navne:
|
|
Eksperimentel: APD791 20mg MD
APD791 placebo for multiple dose + Aspirin + Clopidogrel
|
Clopidogrel
Andre navne:
Temanogrel
Andre navne:
Aspirin
Andre navne:
|
|
Placebo komparator: APD791 placebo MD
APD791 placebo for multiple dose + Aspirin + Clopidogrel
|
Clopidogrel
Andre navne:
Temanogrel
Andre navne:
Aspirin
Andre navne:
Placebo for APD791
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
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
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
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Ledende efterforsker: Gyunseop Bae, M.D., Asan Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Myokardieiskæmi
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Karsygdomme
- Akut koronarsyndrom
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Blodpladeaggregationshæmmere
- Cyclooxygenase-hæmmere
- Antipyretika
- Purinerge P2Y-receptorantagonister
- Purinerge P2-receptorantagonister
- Purinerge antagonister
- Purinerge midler
- Serotoninmidler
- Serotonin 5-HT2-receptorantagonister
- Serotonin-antagonister
- Aspirin
- Clopidogrel
- APD791
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- ID-TMG-102
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