Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase I Study to Evaluate the Intravenous Pharmacokinetics and the Absolute Bioavailability of SRT2104 Given as a 250mg Oral Suspension in Healthy Subjects
The primary objective of this study is to determine the absolute bioavailability of SRT2104
as a 250 mg suspension, and to define the intravenous pharmacokinetics of SRT2104.
The secondary objective of this study is to assess the potential systemic metabolite burden
of SRT2104, and to provide plasma and urine samples for subsequent metabolite profiling and
identification.
This will be a single centre, combined IV and oral single dose, open-label study in healthy
male volunteers.
Each subject will receive the following formulations on a single study day:
1. Regimen A: A single 10 mL oral dose of 250 mg SRT2104 delivered as a suspension
formulation;
2. Regimen B: A single intravenous dose of 10 mL containing 100 µg (not more than 250 nCi,
9.25 kBq) Carbon-14 radio-labeled SRT2104 , administered by IV infusion over 15
minutes, starting 2 hours and 45 minutes after the oral dose.
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