Phase I Study - PK/PD of Metyrapone given to patients with AI and SCS

• Research type

  Research Study

• Full title

  A prospective, open-label, single-center, randomized study to assess the safety, pharmacokinetics, and pharmacodynamics of daily doses of metyrapone given to patients with adrenocortical incidentaloma and sub-clinical Cushing's syndrome.

• IRAS ID

  109693

• Contact name

  John Newell-Price

• Eudract number

  2012-002586-35

• ISRCTN Number

  n/a

• Research summary

  This study is a phase I study in which we aim to evaluate baseline levels of the hormone cortisol in patients with benign adrenal tumor and hypersecretion of cortisol and in two groups of control subjects, namely subjects with a benign adrenal tumour and normal cortisol and control subjects without an adrenal tumour. In the second part of the study, we will evaluate cortisol response after a daily dose of metyrapone and blood levels of metyrapone and metyrapol (its byproduct).

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  12/YH/0358

• Date of REC Opinion

  6 Sep 2012

• REC opinion

  Further Information Favourable Opinion