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Inhibition of the enzyme 11 β ‐hydroxysteroid dehydrogenase type 1 (11β‐ HSD 1) represents a potential mechanism for improving pain conditions.  ASP 3662 is a potent and selective inhibitor of 11β‐ HSD 1. Two phase I clinical studies were conducted to assess the safety, tolerability, pharmacokinetics ( PK s), and pharmacodynamics (PDs) of single and multiple ascending doses of  ASP 3662 in healthy young and elderly non‐Japanese and young Japanese subjects. Nonlinear, more than dose‐proportional  PK s were observed for  ASP 3662 after single‐dose administration, particularly at lower doses (≤ 6 mg); the  PK s at steady state were dose proportional, although the time to  ASP 3662 steady state was dose dependent at lower doses (≤ 2 mg). Similar  PK s were observed among young Japanese, young non‐Japanese, and elderly non‐Japanese subjects. Specific inhibition of 11β‐ HSD 1 occurred after both single and multiple doses of  ASP 3662. A marked dissociation between PKs and PDs was observed after single but not multiple doses of  ASP 3662.  ASP 3662 was generally safe and well tolerated.

clinical and translational science

Safety, Pharmacokinetics, and Pharmacodynamics of  ASP 3662, a Novel 11β‐Hydroxysteroid Dehydrogenase Type 1 Inhibitor, in Healthy Young and Elderly Subjects