Covance, one of the world's largest drug development services companies, announced that it has recently completed a "cold" microdose study under the exploratory Investigational New Drug (expIND) pathway. Microdose studies, which use a small amount of drug and small cohorts to assess initial pharmacokinetics, can be an important stepping-stone toward expanded development and have the potential to cut time and cost from drug development.
This first-in-human trial, conducted at the Covance Clinical Research Unit in Honolulu on behalf of a major pharmaceutical company, provided pivotal pharmacokinetic (PK) human data only ten weeks after submitting the expIND to the FDA. The study was also significant because it was conducted without a 14-C label on the compound, greatly reducing the time and cost to prepare dosage. Most importantly, the study provided very rapid pharmacokinetic data and enabled a critical go-forward decision by the sponsor to pursue further development of the compound. Data produced in such studies can aid study architects with dose formulation and design of subsequent clinical trials, and can also be included in the IND filing.
Covance, a pioneer of functional microdose methodology, hails the success of this study as a strong indication that microdosing has practical application in identifying promising compounds for full-scale trials. Covance's depth of knowledge in microdose studies was helpful in developing the study protocol and identifying the ideal testing panel in very short time.
"The ability to gather human PK information about drugs at sub-therapeutic, sub-toxic doses very early in the development cycle is invaluable because the additional data can provide insight into how a drug impacts human physiology before larger investment is made in other stages of development," said Dr. Jon Ruckle, Medical Director for Covance in Honolulu. "In pharmaceutical development, microdose studies are proving to be viable, important steps in the testing process - a logical outcome of the evolving 'learn and confirm' drug development paradigm."
Covance conducted its first human microdose study with a pharmaceutical compound in the U.S. in 2005 and is currently conducting microdose studies in Madison, Wisconsin as well as Honolulu, Hawaii.
Covance, (covance.com) with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies with annual revenues greater than $1.3 billion, global operations in more than 20 countries, and more than 8,100 employees worldwide. Information on Covance's products and services, recent press releases, and SEC filings can be obtained through its website.
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