RGH-706-002 Multiple Oral Doses of RGH-706 in Overweight or Obese HVs
Research type
Research Study
Full title
A Study to Examine the Tolerability, Safety, and Pharmacokinetics of Single and Multiple Oral Doses of RGH-706 in Overweight or Obese Otherwise Healthy Male Subjects
IRAS ID
250115
Contact name
Jim Bush
Contact email
Sponsor organisation
Gedeon Richter Plc.
Eudract number
2018-002674-49
Duration of Study in the UK
0 years, 8 months, 1 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.
This is the second time RGH-706 has been administered in humans and this study is a multiple-dosing study. Overall, 72 subjects will be studied in 6 cohorts, with each cohort consisting of 12 subjects. Each subject will participate in 1 Cohort only. In each of Cohorts 1 to 6, 9 subjects will receive RGH-706 and 3 subjects will receive matching placebo (a dummy drug).
Subjects will receive either RGH-706 or placebo on the morning of Day 1. After a 96 hour washout period, subjects will then receive a once daily dose of either RGH-706 or placebo from Day 5 to 18; in a double blinded fashion (neither the site staff nor the subject will know whether they have received RGH-706 or placebo). All doses will be administered in the fasted state. In all cohorts, two subjects (1 RGH-706 and 1 placebo) will be dosed at least 96 hours prior to the rest of the cohort (sentinel group). Data from the sentinel group will be reviewed prior to dosing the remaining 10 subjects in this cohort (8 receiving RGH-706 and 2 placebo). Up to 3 further cohorts of 12 subjects may be included.
Subjects will check in to the unit on Day -2 and check out on Day 19, they will attend for three non-residential visits (Day 20, 21 and 22) and a follow up visit 7-10 days after the last dose has been administered. Subject participation from screening to follow-up is expected to last approximately 8 weeks.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0495
Date of REC Opinion
13 Sep 2018
REC opinion
Favourable Opinion