Neurogen completes ascending dose obesity studies

The initial phase of the multiple ascending dose (MAD) study utilized three times per day dosing (tid) for 14 days in healthy obese subjects exposed to a high caloric diet. During this phase moderate induction of the liver enzyme CYP 3A4 occurred, increasing the probability of accelerating metabolism of other drugs administered concomitantly. In addition, during the initial phase of the MAD study, lipid lowering effects were observed.

The follow-up study was designed to test the effect of twice per day dosing (bid) in healthy obese subjects on a restricted caloric diet for 14 days. Using bid dosing, CYP3A4 induction was substantially reduced as measured by treatment with midazolam, a drug sensitive to changes in CYP 3A4 levels. With less frequent dosing and caloric restriction in the current trial, no effect on lipids was observed.