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Clinilabs Inc announced that they have been selected to conduct a Phase I clinical trial of an investigational new drug for insomnia. The study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics in a group of healthy, normal subjects and in otherwise healthy subjects who suffer from primary insomnia.
The study will begin to look at dose response on certain polysomnographically-defined sleep parameters and wake-time functioning, compared to the effects of an FDA-approved insomnia drug and placebo in subjects with insomnia. President and CEO, Dr. Gary Zammit reaffirmed Clinilabs’ unique attributes that helped secure the award. He states: “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.”
Enrollment for this study is expected to begin in October at which time healthy adult males and females, and those who have been diagnosed with primary insomnia, between the ages of 18 – 64 are encouraged to participate. Individuals in the New York City metro area who would like to participate can contact Clinilabs’ call center at 212-994-4567 to prequalify. Additional information may also be found by visiting www.clinilabs.com/insomnia.