Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Study of APD-791 With Aspirin and/or Clopidogrel (TG1C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02034292
Recruitment Status : Terminated (Sponsor Decision)
First Posted : January 13, 2014
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Asan Medical Center
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

Brief Summary:
Evaluating safety and PK parameter of APD-791 when co-administered with aspirin and clopidogrel.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Phase I Study to Assess the Safety of APD-791 When Co-administered With Aspirin
Actual Study Start Date : February 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 10mg MD
APD791 10mg Multiple dose and
Drug: Clopidogrel
Drug: Aspirin
Drug: APD791
Experimental: 20mg MD
APD791 20mg Multiple dose
Drug: Clopidogrel
Drug: Aspirin
Drug: APD791
Experimental: 40mg MD
APD791 40mg Multiple dose
Drug: Clopidogrel
Drug: Aspirin
Drug: APD791
Experimental: 60mg MD
APD791 60mg Multiple dose
Drug: Clopidogrel
Drug: Aspirin
Drug: APD791
Placebo Comparator: Placebo MD
Placebo for Multiple dose group
Drug: Clopidogrel
Drug: Aspirin
Drug: APD791
Experimental: 120mg SD
APD791 120mg Single dose
Drug: Clopidogrel
Drug: Aspirin
Drug: APD791
Experimental: 240mg SD
APD791 240mg Single dose
Drug: Clopidogrel
Drug: Aspirin
Drug: APD791
Experimental: 320mg SD
APD791 320mg Single dose
Drug: Clopidogrel
Drug: Aspirin
Drug: APD791
Placebo Comparator: Placebo SD
Placebo for Single dose
Drug: Clopidogrel
Drug: Aspirin
Drug: Placebo



Primary Outcome Measures :
  1. To assess the safety of APD791 when orally co-administered with Aspirin and Clopidogrel in healthy subjects [ Time Frame: safety review will be conducted at every end of dosing (about every 2 or 3 weeks) ]
    Adverse reaction monitoring for subjective or objective symptoms Physical examination Vital signs 12-electrode ECG Laboratory tests


Secondary Outcome Measures :
  1. Pharmacokinetic characteristic evaluation variable [ Time Frame: After last patient last visit. About 8month later since start of the study. ]

    Non-compartmental analysis is conducted by using APD791 and its metabolite, M1 and M2 and the following pharmacokinetic evaluation variables are calculated.

    Cmax0-12, Cmax,ss (Day 7 only), Cmin,ss (Day 7 only), tmax0-12, tmax,ss (Day 7 only), λz, t1/2β, AUC0-12 (Day 1 only), AUCinf, Accumulation index, CL/F, MRT, Vz/F


  2. Pharmacodynamic characteristic evaluation variable [ Time Frame: Day1, Day4, Day7 of every dose for mutiple dose group and first day for single dose group. ]
    Pharmacodynam1) % inhibition of serotonin-stimulated platelet aggregation 2) Change in % inhibition of serotonin-stimulated platelet aggregation 3) % inhibition of TRAP-induced platelet aggregation ic characteristic evaluation variable



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:   All
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
  5. 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
  6. 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
  7. a person more than hemoglobin 12 g/dL at the time of screening (a woman more than hemoglobin 11 g/dL)
  8. 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
  9. a person who voluntarily decides to participate in this clinical trial and gives written consent on strict clinical trial compliance
  10. a person whose blood can be collected during a study period with visit for monitoring

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
  19. a person decided to be inappropriate to participate in this clinical trial according to investigator's medical decision on the result of laboratory tests, such as complete blood cell count, general chemical test, clinicochemical urinalysis, and physical examination, vital signs, ECG, other tests excluding exclusion criteria 17 items conducted before subject selection for a clinical trial

Layout table for additonal information
Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT02034292     History of Changes
Other Study ID Numbers: ID-TG1C-1301
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Aspirin
Clopidogrel
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
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