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
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
- 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.
Studientyp
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Phase
Phase
- Phase 1
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Screening
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Experimental: APD791 10mg single dose
|
Temanogrel
Andere Namen:
|
|
Experimental: APD791 20mg single dose
|
Temanogrel
Andere Namen:
|
|
Experimental: APD791 40mg single dose
|
Temanogrel
Andere Namen:
|
|
Experimental: APD791 10mg
APD791 10mg single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andere Namen:
Temanogrel
Andere Namen:
Aspirin
Andere Namen:
|
|
Experimental: APD791 20mg
APD791 20mg single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andere Namen:
Temanogrel
Andere Namen:
Aspirin
Andere Namen:
|
|
Experimental: APD791 40mg
APD791 40mg single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andere Namen:
Temanogrel
Andere Namen:
Aspirin
Andere Namen:
|
|
Experimental: APD791 80mg
APD791 80mg single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andere Namen:
Temanogrel
Andere Namen:
Aspirin
Andere Namen:
|
|
Experimental: APD791 160mg
APD791 160mg single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andere Namen:
Temanogrel
Andere Namen:
Aspirin
Andere Namen:
|
|
Experimental: APD791 240mg
APD791 240mg single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andere Namen:
Temanogrel
Andere Namen:
Aspirin
Andere Namen:
|
|
Experimental: APD791 320mg
APD791 320mg single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andere Namen:
Temanogrel
Andere Namen:
Aspirin
Andere Namen:
|
|
Placebo-Komparator: APD791 Placebo
APD791 placebo for single dose + Aspirin + Clopidogrel
|
Clopidogrel
Andere Namen:
Temanogrel
Andere Namen:
Aspirin
Andere Namen:
Placebo for APD791
Andere Namen:
|
|
Experimental: APD791 2mg MD
APD791 2mg multiple dose + Aspirin + Clopidogrel
|
Clopidogrel
Andere Namen:
Temanogrel
Andere Namen:
Aspirin
Andere Namen:
|
|
Experimental: APD791 5mg MD
APD791 5mg multiple dose + Aspirin + Clopidogrel
|
Clopidogrel
Andere Namen:
Temanogrel
Andere Namen:
Aspirin
Andere Namen:
|
|
Experimental: APD791 10mg MD
APD791 10mg multiple dose + Aspirin + Clopidogrel
|
Clopidogrel
Andere Namen:
Temanogrel
Andere Namen:
Aspirin
Andere Namen:
|
|
Experimental: APD791 20mg MD
APD791 placebo for multiple dose + Aspirin + Clopidogrel
|
Clopidogrel
Andere Namen:
Temanogrel
Andere Namen:
Aspirin
Andere Namen:
|
|
Placebo-Komparator: APD791 placebo MD
APD791 placebo for multiple dose + Aspirin + Clopidogrel
|
Clopidogrel
Andere Namen:
Temanogrel
Andere Namen:
Aspirin
Andere Namen:
Placebo for APD791
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Pharmacokinetics-Cmax
Zeitfenster: Day1, Day2, Day3, Day4, Day 7
|
Day1, Day2, Day3, Day4, Day 7
|
|
Pharmacokinetics-Tmax
Zeitfenster: Day1, Day2, Day3, Day4, Day 7
|
Day1, Day2, Day3, Day4, Day 7
|
|
Pharmacodynamics-% inhibition of serotonin-stimulated platelet aggregation
Zeitfenster: Day1, Day2, Day4, Day7, Day 8
|
Day1, Day2, Day4, Day7, Day 8
|
|
Pharmacodynamics-change of serotonin-stimulated platelet aggregation
Zeitfenster: Day1, Day4, Day7
|
Day1, Day4, Day7
|
|
Pharmacodynamics-% inhibition of TRAP-induced platelet aggregation
Zeitfenster: 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.
|
Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
adverse event monitoring
Zeitfenster: up to post-study visit(8day±2)
|
up to post-study visit(8day±2)
|
|
physical examination
Zeitfenster: up to post-study visit(8day±2)
|
up to post-study visit(8day±2)
|
|
vital signs
Zeitfenster: up to post-study visit(8day±2)
|
up to post-study visit(8day±2)
|
|
ECG
Zeitfenster: up to post-study visit(8day±2)
|
up to post-study visit(8day±2)
|
|
laboratory test
Zeitfenster: up to post-study visit(8day±2)
|
up to post-study visit(8day±2)
|
Mitarbeiter und Ermittler
Sponsor
Sponsor
Mitarbeiter
Mitarbeiter
Ermittler
Ermittler
- Hauptermittler: Gyunseop Bae, M.D., Asan Medical Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Myokardischämie
- Herzkrankheiten
- Herz-Kreislauf-Erkrankungen
- Gefäßerkrankungen
- Akutes Koronar-Syndrom
- Physiologische Wirkungen von Arzneimitteln
- Neurotransmitter-Agenten
- Molekulare Mechanismen der pharmakologischen Wirkung
- Agenten des peripheren Nervensystems
- Enzym-Inhibitoren
- Analgetika
- Agenten des sensorischen Systems
- Entzündungshemmende Mittel, nichtsteroidal
- Analgetika, nicht narkotisch
- Entzündungshemmende Mittel
- Antirheumatika
- Fibrinolytische Mittel
- Fibrinmodulierende Mittel
- Thrombozytenaggregationshemmer
- Cyclooxygenase-Inhibitoren
- Antipyretika
- Purinerge P2Y-Rezeptorantagonisten
- Purinerge P2-Rezeptorantagonisten
- Purinerge Antagonisten
- Purinerge Wirkstoffe
- Serotonin-Agenten
- Serotonin-5-HT2-Rezeptorantagonisten
- Serotonin-Antagonisten
- Aspirin
- Clopidogrel
- APD791
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- ID-TMG-102
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