NCT02419820

Dose-escalation, Repeated and Single Oral Dosing Study

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: IlDong Pharmaceutical Co Ltd · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	APD791	Temanogrel
DRUG	Clopidogrel	Clopidogrel
DRUG	Aspirin	Aspirin
DRUG	Placebo for APD791	Placebo for APD791

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-04-17
• Last updated: 2019-02-15