Dose-escalation, Repeated and Single Oral Dosing Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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APD791 10mg single dose

Group Type EXPERIMENTAL

APD791

Intervention Type DRUG

Temanogrel

APD791 20mg single dose

Group Type EXPERIMENTAL

APD791

Intervention Type DRUG

Temanogrel

APD791 40mg single dose

Group Type EXPERIMENTAL

APD791

Intervention Type DRUG

Temanogrel

APD791 10mg

APD791 10mg single dose + Aspirin + Clopidogrel

Group Type EXPERIMENTAL

APD791

Intervention Type DRUG

Temanogrel

Clopidogrel

Intervention Type DRUG

Clopidogrel

Aspirin

Intervention Type DRUG

Aspirin

APD791 20mg

APD791 20mg single dose + Aspirin + Clopidogrel

Group Type EXPERIMENTAL

APD791

Intervention Type DRUG

Temanogrel

Clopidogrel

Intervention Type DRUG

Clopidogrel

Aspirin

Intervention Type DRUG

Aspirin

APD791 40mg

APD791 40mg single dose + Aspirin + Clopidogrel

Group Type EXPERIMENTAL

APD791

Intervention Type DRUG

Temanogrel

Clopidogrel

Intervention Type DRUG

Clopidogrel

Aspirin

Intervention Type DRUG

Aspirin

APD791 80mg

APD791 80mg single dose + Aspirin + Clopidogrel

Group Type EXPERIMENTAL

APD791

Intervention Type DRUG

Temanogrel

Clopidogrel

Intervention Type DRUG

Clopidogrel

Aspirin

Intervention Type DRUG

Aspirin

APD791 160mg

APD791 160mg single dose + Aspirin + Clopidogrel

Group Type EXPERIMENTAL

APD791

Intervention Type DRUG

Temanogrel

Clopidogrel

Intervention Type DRUG

Clopidogrel

Aspirin

Intervention Type DRUG

Aspirin

APD791 240mg

APD791 240mg single dose + Aspirin + Clopidogrel

Group Type EXPERIMENTAL

APD791

Intervention Type DRUG

Temanogrel

Clopidogrel

Intervention Type DRUG

Clopidogrel

Aspirin

Intervention Type DRUG

Aspirin

APD791 320mg

APD791 320mg single dose + Aspirin + Clopidogrel

Group Type EXPERIMENTAL

APD791

Intervention Type DRUG

Temanogrel

Clopidogrel

Intervention Type DRUG

Clopidogrel

Aspirin

Intervention Type DRUG

Aspirin

APD791 Placebo

APD791 placebo for single dose + Aspirin + Clopidogrel

Group Type PLACEBO_COMPARATOR

APD791

Intervention Type DRUG

Temanogrel

Clopidogrel

Intervention Type DRUG

Clopidogrel

Aspirin

Intervention Type DRUG

Aspirin

Placebo for APD791

Intervention Type DRUG

Placebo for APD791

APD791 2mg MD

APD791 2mg multiple dose + Aspirin + Clopidogrel

Group Type EXPERIMENTAL

APD791

Intervention Type DRUG

Temanogrel

Clopidogrel

Intervention Type DRUG

Clopidogrel

Aspirin

Intervention Type DRUG

Aspirin

APD791 5mg MD

APD791 5mg multiple dose + Aspirin + Clopidogrel

Group Type EXPERIMENTAL

APD791

Intervention Type DRUG

Temanogrel

Clopidogrel

Intervention Type DRUG

Clopidogrel

Aspirin

Intervention Type DRUG

Aspirin

APD791 10mg MD

APD791 10mg multiple dose + Aspirin + Clopidogrel

Group Type EXPERIMENTAL

APD791

Intervention Type DRUG

Temanogrel

Clopidogrel

Intervention Type DRUG

Clopidogrel

Aspirin

Intervention Type DRUG

Aspirin

APD791 20mg MD

APD791 placebo for multiple dose + Aspirin + Clopidogrel

Group Type EXPERIMENTAL

APD791

Intervention Type DRUG

Temanogrel

Clopidogrel

Intervention Type DRUG

Clopidogrel

Aspirin

Intervention Type DRUG

Aspirin

APD791 placebo MD

APD791 placebo for multiple dose + Aspirin + Clopidogrel

Group Type PLACEBO_COMPARATOR

APD791

Intervention Type DRUG

Temanogrel

Clopidogrel

Intervention Type DRUG

Clopidogrel

Aspirin

Intervention Type DRUG

Aspirin

Placebo for APD791

Intervention Type DRUG

Placebo for APD791

Interventions

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APD791

Temanogrel

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

Aspirin

Intervention Type DRUG

Placebo for APD791

Intervention Type DRUG

Other Intervention Names

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Temanogrel Plavix Aspirin Protect Placebo for Temanogrel

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes