Clinical trial NCT02419820: Dose-escalation, Repeated and Single Oral Dosing Study
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Acute Coronary Syndrome
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
Collaborators: name: Asan Medical Center
First posted: 2015-04-17
Enrollment: 104
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Eligibility 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

Primary outcomes:
measure: Pharmacokinetics-Cmax
timeFrame: Day1, Day2, Day3, Day4, Day 7
measure: Pharmacokinetics-Tmax
timeFrame: Day1, Day2, Day3, Day4, Day 7
measure: Pharmacodynamics-% inhibition of serotonin-stimulated platelet aggregation
timeFrame: Day1, Day2, Day4, Day7, Day 8
measure: Pharmacodynamics-change of serotonin-stimulated platelet aggregation
timeFrame: Day1, Day4, Day7
measure: Pharmacodynamics-% inhibition of TRAP-induced platelet aggregation
timeFrame: Day1, Day4, Day7 of every dose for mutiple dose group and first day for single dose group.
Secondary outcomes:
measure: adverse event monitoring
timeFrame: up to post-study visit(8day±2)
measure: physical examination
timeFrame: up to post-study visit(8day±2)
measure: vital signs
timeFrame: up to post-study visit(8day±2)
measure: ECG
timeFrame: up to post-study visit(8day±2)
measure: laboratory test
timeFrame: up to post-study visit(8day±2)
Other outcomes:
Locations:
Study officials:
affiliation: Asan Medical Center
name: Gyunseop Bae, M.D.
role: PRINCIPAL_INVESTIGATOR
References: