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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

Tracking Information
First Submitted Date  ICMJE December 12, 2013
First Posted Date  ICMJE January 13, 2014
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE February 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02034292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of APD-791 With Aspirin and/or Clopidogrel
Official Title  ICMJE Phase I Study to Assess the Safety of APD-791 When Co-administered With Aspirin
Brief Summary Evaluating safety and PK parameter of APD-791 when co-administered with aspirin and clopidogrel.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE
  • Drug: Clopidogrel
  • Drug: Aspirin
  • Drug: APD791
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: 10mg MD
    APD791 10mg Multiple dose and
    Interventions:
    • Drug: Clopidogrel
    • Drug: Aspirin
    • Drug: APD791
  • Experimental: 20mg MD
    APD791 20mg Multiple dose
    Interventions:
    • Drug: Clopidogrel
    • Drug: Aspirin
    • Drug: APD791
  • Experimental: 40mg MD
    APD791 40mg Multiple dose
    Interventions:
    • Drug: Clopidogrel
    • Drug: Aspirin
    • Drug: APD791
  • Experimental: 60mg MD
    APD791 60mg Multiple dose
    Interventions:
    • Drug: Clopidogrel
    • Drug: Aspirin
    • Drug: APD791
  • Placebo Comparator: Placebo MD
    Placebo for Multiple dose group
    Interventions:
    • Drug: Clopidogrel
    • Drug: Aspirin
    • Drug: APD791
  • Experimental: 120mg SD
    APD791 120mg Single dose
    Interventions:
    • Drug: Clopidogrel
    • Drug: Aspirin
    • Drug: APD791
  • Experimental: 240mg SD
    APD791 240mg Single dose
    Interventions:
    • Drug: Clopidogrel
    • Drug: Aspirin
    • Drug: APD791
  • Experimental: 320mg SD
    APD791 320mg Single dose
    Interventions:
    • Drug: Clopidogrel
    • Drug: Aspirin
    • Drug: APD791
  • Placebo Comparator: Placebo SD
    Placebo for Single dose
    Interventions:
    • Drug: Clopidogrel
    • Drug: Aspirin
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 17, 2018)
16
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2014)
88
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02034292
Other Study ID Numbers  ICMJE ID-TG1C-1301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party IlDong Pharmaceutical Co Ltd
Study Sponsor  ICMJE IlDong Pharmaceutical Co Ltd
Collaborators  ICMJE Asan Medical Center
Investigators  ICMJE Not Provided
PRS Account IlDong Pharmaceutical Co Ltd
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP