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Dose-escalation, Repeated and Single Oral Dosing Study

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ClinicalTrials.gov Identifier: NCT02419820
Recruitment Status : Terminated (Sponsor Decision)
First Posted : April 17, 2015
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Asan Medical Center
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: APD791 Drug: Clopidogrel Drug: Aspirin Drug: Placebo for APD791 Phase 1

Detailed Description:
  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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: 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
Actual Study Start Date : March 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: APD791 10mg single dose
APD791 10mg single dose
 Drug: APD791
Temanogrel
Other Name: Temanogrel
Experimental: APD791 20mg single dose
APD791 20mg single dose
 Drug: APD791
Temanogrel
Other Name: Temanogrel
Experimental: APD791 40mg single dose
APD791 40mg single dose
 Drug: APD791
Temanogrel
Other Name: Temanogrel
Experimental: APD791 10mg
APD791 10mg single dose + Aspirin + Clopidogrel
 Drug: APD791
Temanogrel
Other Name: Temanogrel

Drug: Clopidogrel
Clopidogrel
Other Name: Plavix

Drug: Aspirin
Aspirin
Other Name: Aspirin Protect
Experimental: APD791 20mg
APD791 20mg single dose + Aspirin + Clopidogrel
 Drug: APD791
Temanogrel
Other Name: Temanogrel

Drug: Clopidogrel
Clopidogrel
Other Name: Plavix

Drug: Aspirin
Aspirin
Other Name: Aspirin Protect
Experimental: APD791 40mg
APD791 40mg single dose + Aspirin + Clopidogrel
 Drug: APD791
Temanogrel
Other Name: Temanogrel

Drug: Clopidogrel
Clopidogrel
Other Name: Plavix

Drug: Aspirin
Aspirin
Other Name: Aspirin Protect
Experimental: APD791 80mg
APD791 80mg single dose + Aspirin + Clopidogrel
 Drug: APD791
Temanogrel
Other Name: Temanogrel

Drug: Clopidogrel
Clopidogrel
Other Name: Plavix

Drug: Aspirin
Aspirin
Other Name: Aspirin Protect
Experimental: APD791 160mg
APD791 160mg single dose + Aspirin + Clopidogrel
 Drug: APD791
Temanogrel
Other Name: Temanogrel

Drug: Clopidogrel
Clopidogrel
Other Name: Plavix

Drug: Aspirin
Aspirin
Other Name: Aspirin Protect
Experimental: APD791 240mg
APD791 240mg single dose + Aspirin + Clopidogrel
 Drug: APD791
Temanogrel
Other Name: Temanogrel

Drug: Clopidogrel
Clopidogrel
Other Name: Plavix

Drug: Aspirin
Aspirin
Other Name: Aspirin Protect
Experimental: APD791 320mg
APD791 320mg single dose + Aspirin + Clopidogrel
 Drug: APD791
Temanogrel
Other Name: Temanogrel

Drug: Clopidogrel
Clopidogrel
Other Name: Plavix

Drug: Aspirin
Aspirin
Other Name: Aspirin Protect
Placebo Comparator: APD791 Placebo
APD791 placebo for single dose + Aspirin + Clopidogrel
 Drug: APD791
Temanogrel
Other Name: Temanogrel

Drug: Clopidogrel
Clopidogrel
Other Name: Plavix

Drug: Aspirin
Aspirin
Other Name: Aspirin Protect

Drug: Placebo for APD791
Placebo for APD791
Other Name: Placebo for Temanogrel
Experimental: APD791 2mg MD
APD791 2mg multiple dose + Aspirin + Clopidogrel
 Drug: APD791
Temanogrel
Other Name: Temanogrel

Drug: Clopidogrel
Clopidogrel
Other Name: Plavix

Drug: Aspirin
Aspirin
Other Name: Aspirin Protect
Experimental: APD791 5mg MD
APD791 5mg multiple dose + Aspirin + Clopidogrel
 Drug: APD791
Temanogrel
Other Name: Temanogrel

Drug: Clopidogrel
Clopidogrel
Other Name: Plavix

Drug: Aspirin
Aspirin
Other Name: Aspirin Protect
Experimental: APD791 10mg MD
APD791 10mg multiple dose + Aspirin + Clopidogrel
 Drug: APD791
Temanogrel
Other Name: Temanogrel

Drug: Clopidogrel
Clopidogrel
Other Name: Plavix

Drug: Aspirin
Aspirin
Other Name: Aspirin Protect
Experimental: APD791 20mg MD
APD791 placebo for multiple dose + Aspirin + Clopidogrel
 Drug: APD791
Temanogrel
Other Name: Temanogrel

Drug: Clopidogrel
Clopidogrel
Other Name: Plavix

Drug: Aspirin
Aspirin
Other Name: Aspirin Protect
Placebo Comparator: APD791 placebo MD
APD791 placebo for multiple dose + Aspirin + Clopidogrel
 Drug: APD791
Temanogrel
Other Name: Temanogrel

Drug: Clopidogrel
Clopidogrel
Other Name: Plavix

Drug: Aspirin
Aspirin
Other Name: Aspirin Protect

Drug: Placebo for APD791
Placebo for APD791
Other Name: Placebo for Temanogrel


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics-Cmax [ Time Frame: Day1, Day2, Day3, Day4, Day 7 ]
  2. Pharmacokinetics-Tmax [ Time Frame: Day1, Day2, Day3, Day4, Day 7 ]
  3. Pharmacodynamics-% inhibition of serotonin-stimulated platelet aggregation [ Time Frame: Day1, Day2, Day4, Day7, Day 8 ]
  4. Pharmacodynamics-change of serotonin-stimulated platelet aggregation [ Time Frame: Day1, Day4, Day7 ]
  5. Pharmacodynamics-% inhibition of TRAP-induced platelet aggregation [ Time Frame: Day1, Day4, Day7 of every dose for mutiple dose group and first day for single dose group. ]

Secondary Outcome Measures :
  1. adverse event monitoring [ Time Frame: up to post-study visit(8day±2) ]
  2. physical examination [ Time Frame: up to post-study visit(8day±2) ]
  3. vital signs [ Time Frame: up to post-study visit(8day±2) ]
  4. ECG [ Time Frame: up to post-study visit(8day±2) ]
  5. laboratory test [ Time Frame: up to post-study visit(8day±2) ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419820


Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd
Asan Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Gyunseop Bae, M.D. Asan Medical Center
More Information
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Layout table for additonal information
Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT02419820    
Other Study ID Numbers: ID-TMG-102
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aspirin
Clopidogrel
APD791
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
 Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists