Dose-escalation, Repeated and Single Oral Dosing Study

NCT02419820 | Terminated Phase 1

• 1 other identifier: ID-TMG-102
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetics-Cmax

  Day1, Day2, Day3, Day4, Day 7

• Pharmacokinetics-Tmax

  Day1, Day2, Day3, Day4, Day 7

• Pharmacodynamics-% inhibition of serotonin-stimulated platelet aggregation

  Day1, Day2, Day4, Day7, Day 8

• Pharmacodynamics-change of serotonin-stimulated platelet aggregation

  Day1, Day4, Day7

• Pharmacodynamics-% inhibition of TRAP-induced platelet aggregation

  Day1, Day4, Day7 of every dose for mutiple dose group and first day for single dose group.

Secondary Outcomes (5)

• adverse event monitoring

  up to post-study visit(8day±2)

• physical examination

  up to post-study visit(8day±2)

• vital signs

  up to post-study visit(8day±2)

• ECG

  up to post-study visit(8day±2)

• laboratory test

  up to post-study visit(8day±2)

Study Arms (16)

APD791 10mg single dose

EXPERIMENTAL

APD791 10mg single dose

Drug: APD791

APD791 20mg single dose

EXPERIMENTAL

APD791 20mg single dose

Drug: APD791

APD791 40mg single dose

EXPERIMENTAL

APD791 40mg single dose

Drug: APD791

APD791 10mg

EXPERIMENTAL

APD791 10mg single dose + Aspirin + Clopidogrel

Drug: APD791; Drug: Clopidogrel; Drug: Aspirin

APD791 20mg

EXPERIMENTAL

APD791 20mg single dose + Aspirin + Clopidogrel

Drug: APD791; Drug: Clopidogrel; Drug: Aspirin

APD791 40mg

EXPERIMENTAL

APD791 40mg single dose + Aspirin + Clopidogrel

Drug: APD791; Drug: Clopidogrel; Drug: Aspirin

APD791 80mg

EXPERIMENTAL

APD791 80mg single dose + Aspirin + Clopidogrel

Drug: APD791; Drug: Clopidogrel; Drug: Aspirin

APD791 160mg

EXPERIMENTAL

APD791 160mg single dose + Aspirin + Clopidogrel

Drug: APD791; Drug: Clopidogrel; Drug: Aspirin

APD791 240mg

EXPERIMENTAL

APD791 240mg single dose + Aspirin + Clopidogrel

Drug: APD791; Drug: Clopidogrel; Drug: Aspirin

APD791 320mg

EXPERIMENTAL

APD791 320mg single dose + Aspirin + Clopidogrel

Drug: APD791; Drug: Clopidogrel; Drug: Aspirin

APD791 Placebo

PLACEBO COMPARATOR

APD791 placebo for single dose + Aspirin + Clopidogrel

Drug: APD791; Drug: Clopidogrel; Drug: Aspirin; Drug: Placebo for APD791

APD791 2mg MD

EXPERIMENTAL

APD791 2mg multiple dose + Aspirin + Clopidogrel

Drug: APD791; Drug: Clopidogrel; Drug: Aspirin

APD791 5mg MD

EXPERIMENTAL

APD791 5mg multiple dose + Aspirin + Clopidogrel

Drug: APD791; Drug: Clopidogrel; Drug: Aspirin

APD791 10mg MD

EXPERIMENTAL

APD791 10mg multiple dose + Aspirin + Clopidogrel

Drug: APD791; Drug: Clopidogrel; Drug: Aspirin

APD791 20mg MD

EXPERIMENTAL

APD791 placebo for multiple dose + Aspirin + Clopidogrel

Drug: APD791; Drug: Clopidogrel; Drug: Aspirin

APD791 placebo MD

PLACEBO COMPARATOR

APD791 placebo for multiple dose + Aspirin + Clopidogrel

Drug: APD791; Drug: Clopidogrel; Drug: Aspirin; Drug: Placebo for APD791

Interventions

APD791 DRUG

Temanogrel

Also known as: Temanogrel

APD791 10mg; APD791 10mg MD; APD791 10mg single dose; APD791 160mg; APD791 20mg; APD791 20mg MD; APD791 20mg single dose; APD791 240mg; APD791 2mg MD; APD791 320mg; APD791 40mg; APD791 40mg single dose; APD791 5mg MD; APD791 80mg; APD791 Placebo; APD791 placebo MD

Clopidogrel DRUG

Clopidogrel

Also known as: Plavix

APD791 10mg; APD791 10mg MD; APD791 160mg; APD791 20mg; APD791 20mg MD; APD791 240mg; APD791 2mg MD; APD791 320mg; APD791 40mg; APD791 5mg MD; APD791 80mg; APD791 Placebo; APD791 placebo MD

Aspirin DRUG

Aspirin

Also known as: Aspirin Protect

APD791 10mg; APD791 10mg MD; APD791 160mg; APD791 20mg; APD791 20mg MD; APD791 240mg; APD791 2mg MD; APD791 320mg; APD791 40mg; APD791 5mg MD; APD791 80mg; APD791 Placebo; APD791 placebo MD

Placebo for APD791 DRUG

Placebo for APD791

Also known as: Placebo for Temanogrel

APD791 Placebo; APD791 placebo MD

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• a healthy adult between 20 and 45 years old at the time of visit for screening
• a person who is able to give written consent
• a person between 50 and 85 kg at the time of visit for screening
• 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
• a person more than hemoglobin 12 g/dL at the time of screening (a woman more than hemoglobin 11 g/dL)
• 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

You may not qualify if:

• a person with the medical history of gastric ulcer, duodenal ulcer or esophageal ulcer within 90 days from the time of visit for screening
• 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
• 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
• a woman with the medical history of dysfunctional uterine bleeding within a year from the time of visit for screening
• a person with the medical history of epilepsy or convulsion
• a person with the medical history of internal organ transplant
• a person expected to be hard to complete a clinical trial because of surgery or medical procedures planned within a clinical trial period
• 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
• a person with hypersensitivity reaction to a drug or gelatin, or the medical history of clinically significant hypersensitivity reaction
• a person with the history of drug abuse, or with a positive reaction to a drug possible to be abused on urine drug screening
• a person with the medical history of alcohol abuse within two years from the time of visit for screening
• a person who is a smoker, or with a positive reaction on a urine nicotine test conducted at the time of visit for screening
• 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
• a person taking other clinical trial drugs within 90 days from the time of visit for screening
• 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

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead
• Asan Medical Center: collaborator

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

APD791; Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Gyunseop Bae, M.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: April 17, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 15, 2019

Record last verified: 2019-02