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Clinilabs to Conduct Phase I Insomnia Trial

Study will assess safety, tolerability, pharmacokinetics and pharmacodynamics

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Clinilabs Inc. has been selected to conduct a Phase I trial of an investigational new drug for insomnia. The study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy subjects and subjects who suffer from primary insomnia. Enrollment is expected to begin in October.
 
The study will examine dose response on certain defined sleep parameters and wake-time functioning, compared to an FDA-approved insomnia drug and placebo in subjects with insomnia.

President and chief executive officer, Dr. Gary Zammit said, “Our core competencies in early phase trials and the development of sleep therapeutics have led the industry to consider us the leading CRO in the field of sleep medicine. There is no other organization with deeper therapeutic-area knowledge, more experience, or greater operational capacity in this field than Clinilabs.”

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