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. 2016 Jan 11;101(3):1174–1180. doi: 10.1210/jc.2015-3574

Figure 1.

Figure 1.

Design of NBI-77860 phase I study (A). Participants (n = 8) received a fixed sequence of three single-dose treatments, administered at approximately 10 pm. For each treatment, subjects were admitted for 24 hours, and blood samples were obtained predose, hourly for the first 4 hours, every 2 hours between 4 and 16 hours postdose, and every 4 hours between 16 and 24 hours after each treatment. Plasma drug concentrations and the hypothalamic-pituitary-adrenal axis biomarkers ACTH, 17OHP, androstenedione, testosterone, and cortisol were measured in all samples. Plasma ACTH rises during the placebo period (B). The concentration × time profile of 600 mg NBI-77860 (dotted line) is shown in relation to the early morning rise of both ACTH (open squares) and 17OHP (open circles) at 2–4 am (shaded bar at 4–6 hours postdose) and the prespecified morning window of 6–10 am (bracket with asterisk at 8–12 hours postdose). Arrow marks pm, when hydrocortisone was administered.