Enhanced Phase I Clinical Trials

March 30, 2011

Earlier Insight Into Critical Human Metabolism and PK

Xceleron’s enhanced Phase I clinical trials give fuller insights into human disposition, bioavailability and metabolism, for an incremental cost on a typical clinical study. Using slightly modified clinical designs, we can provide critical ADME and PK data much earlier in the drug development process than when traditional approaches are used.

Our enhanced Phase I studies do not require additional safety or dosimetry data over traditional Phase I clinical trials. As a result, when 14C-labeled drug is available (as it typically is from preclinical studies), we can generate valuable human disposition, bioavailability or metabolism data within existing drug development timelines.

Drug researchers can gain access to this data years earlier than they would using traditional clinical studies, and can do it for a fraction of the cost with AMS-enabled studies.

Xceleron’s enhanced Phase I Studies have been used to:

  • Obtain human absolute bioavailability data
  • Guide formulation development strategy
  • Predict late stage clinical outcomes and de-risk Phase II
  • Gain vital PK data on high potency drugs in sensitive populations
  • Quantify drug distribution in target tissues such as cerebral spinal fluid or skin blisters
  • Gain a first view of human metabolites for safety assessments

Click here to read more about human metabolite profiling in Phase I.
See our IVPK Studies for a cost effective way to gain early bioavailability data.

>> Read more in this recent report in Bioanalysis: AMS Method Validation for Quantitation in Pharmacokinetic Studies with Concomitant Extravascular and Intravenous Administration.
>> Contact us to discuss how we can enhance your Phase I trials to give fuller insights.
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