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news.Arena Pharmaceuticals has initiated dosing in a Phase I clinical trial evaluating APD791, its rally administered, internally discovered drug candidate intended for the treatment of arterial thrombo-embolic diseases.
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This Phase I trial is planned to enroll up to 72 healthy adult volunteers and is primarily intended to evaluate the safety and tolerability of single ascending doses of APD791. In addition, the trial will also evaluate the pharmacokinetics and pharmacodynamics of APD791.
The trial is a randomized, placebo-controlled, double-blind, single-ascending dose trial in healthy male and female volunteers between the ages of 19 and 45 years old. It will include up to eight cohorts of nine volunteers each. In each cohort, three volunteers will be assigned to receive placebo and six volunteers will be assigned to receive APD791 in an ascending dose fashion.
In addition to evaluating APD791's safety and tolerability profile, the trial will also evaluate the pharmacokinetics and pharmacodynamics of single oral doses of APD791. Pharmacodynamics will be evaluated by measuring ex vivo inhibition of platelet aggregation.
A second Phase I trial is planned to start after the first trial is completed. The second trial is primarily intended to evaluate the safety and tolerability of multiple ascending doses of APD791.