A study to examine oral doses of RGH-618 in healthy male volunteers

• Research type

  Research Study

• Full title

  A Study to Examine the Tolerability, Safety and Pharmacokinetics of Single Oral Doses of RGH-618 in Healthy Male Volunteers

• IRAS ID

  99327

• Contact name

  Simon L Singer

• Sponsor organisation

  Gedeon Richter PLC

• Eudract number

  2011-005865-19

• Research summary

  This study is an evaluation of the safety, blood levels and tolerability of oral doses of RGH-618 in healthy subjects. The investigational study drug RGH-618 is being developed by the sponsor, Gedeon Richter Plc. as an intended treatment for anxiety. This study will be the first time RGH-618 is administered to humans. The aim of the study is to assess the effects of a capsule formulation of RGH-618 in 2 parts.PART 1: A single-dose, double-blind, randomised, placebo-controlled study. Up to 8 cohorts may be recruited for the study. Cohort 1 will start with 8 subjects. In subsequent cohorts, 8 or 12 subjects will be studied, based upon the pharmacokinetic and safety data obtained in Cohort 1 and subsequent cohorts, if applicable. Subjects will be randomised to receive RGH-618 or placebo (dummy treatment) in a ratio of 3:1 (6:2 for cohorts of 8 subjects or 9:3 for cohorts of 12 subjects). The order in which volunteers will be allocated to treatments is random. The dose in subsequent cohorts may be increased or a lower dose, an intermediate dose or a repeat of a previously administered dose may also be selected. PART 2: An open-label, randomised, two-way crossover study on the effect of food on RGH-618 pharmacokinetics. Up to 24 healthy subjects will be enrolled in up to two dosing cohorts. 12 subjects per cohort. Subjects will receive a single oral dose of RGH-618 in 2 treatment periods. The order of the treatment periods for each subject will be determined by chance. Apart from whether subjects will receive a high fat breakfast, both treatment periods will be the same. Subjects will be expected to attend a screening visit, treatment period and follow up visit in each part of the study. Additional visits for pharmacokinetic measurements may be needed in both parts.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0104

• Date of REC Opinion

  6 Mar 2012

• REC opinion

  Further Information Favourable Opinion