The pharmacokinetics, pharmacodynamics, safety and tolerability following 7 days daily oral treatment with NN703 in healthy male subjects.

Abstract The aim of the present study was to assess the safety, pharmacokinetics and pharmacodynamics (including specificity) of NN703 (tabimorelin), a growth hormone (GH) secretagogue, in healthy male subjects following treatment for 7 days once-daily. This was a randomized, double-blind and placebo-controlled study with four active dose levels: 1.71, 3.0, 4.5 and 6.86 mg/kg body weight. There was a dose-related increase for GH area under the curve (AUC) (0–12 h) and GH C max (0–12 h); these were significantly higher on both days 1 and 7 as compared with placebo treatment ( P = 0.04 to P P P = 0.04–0.0006) and at the highest dose level for IGFBP-3 ( P = 0.03). There was no statistically significant increase in AUC (0–5 h) for follicle-stimulating hormone, luteinizing hormone and cortisol between active and placebo treatment for day 1 or 7. On day 1 only, a statistically significant increase in AUC (0–5 h) was found for prolactin at 1.71 and 6.86 mg/kg ( P P P P