A study examining the effects of RGH-706 in healthy male volunteers

• Full title

  A study to examine the tolerability, safety and pharmacokinetics of single oral doses of RGH-706 in healthy male volunteers.

• IRAS ID

  220411

• Contact name

  Publication of this data is currently deferred.

• Contact email

  Publication of this data is currently deferred.

• Sponsor organisation

  Gedeon Richter Plc.

• Eudract number

  Publication of this data is currently deferred.

• Duration of Study in the UK

  0 years, 8 months, 4 days

• Research summary

  RGH-706 is being developed as a treatment for obesity. RGH-706 blocks receptors in the body called Melanin-Concentrating Hormone Receptors (MCHR1) which stimulate food intake and regulate energy balance. Blocking these receptors is thought to be a viable anti-obesity therapy. \nThis will be the first time RGH-706 has been administered in humans. The study will comprise of two parts.\nPart 1 will be a single ascending dose study. Subjects will receive either RGH-706 or placebo (a dummy drug) on one occasion only; in a double blinded fashion (neither the site staff nor the subject will know whether they have received RGH-706 or placebo). Cohort 1 will comprise 8 subjects (6 RGH-706 and 2 placebo); further cohorts may comprise up to 12 subjects. In the first cohort two subjects (1 RGH-706 and 1 placebo) will be dosed at least 48 hours prior to the rest of the cohort (sentinel group). Data from the sentinel group will be reviewed prior to dosing the remaining 6 subjects in this cohort (5 RGH-706 and 1 placebo). A dose escalation decision will be made when at least 24 hour post dose safety and Pharmacokinetic (concentrations of RGH-706 in blood) data from the previous dose has been reviewed. Up to 10 dose levels of RGH-706 may be explored.\n\nPart 2 will look at the effect of food on RGH-706 concentrations in the blood, this will not be blinded. The dose to be used will be decided after review of data from Part 1. Twelve volunteers will receive the study drug twice, once after an overnight fast, and once after a high-fat breakfast. Six subjects will receive the dose fasting on the first occasion and after food on the second occasion and the other 6 subjects in the reverse order. A second food effect group may be dosed at a different dose level.\n

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  17/NW/0076

• Date of REC Opinion

  27 Feb 2017

• REC opinion

  Favourable Opinion