GRC 27864 - A Three-Part Safety, PK, PD, Elderly and Food effect Study
Research type
Research Study
Full title
A Three-Part, Phase I Study Of Orally Administered GRC 27864, A Novel, Microsomal Prostaglandin E Synthase-1 Enzyme (mPGES-1) Inhibitor, To Evaluate The Safety, Tolerability And PK Of Single Ascending Doses In Healthy, Adult Subjects (Part 1a), And Of a Single Dose In Elderly Subjects (Part 2); The Effect Of Food On PK (Part 1b) In Healthy, Adult Subjects; And To Compare The Effects On Prostanoid Metabolism With Celecoxib (Part 3) In Healthy, Adult Subjects
IRAS ID
153080
Contact name
Jim Bush
Contact email
Sponsor organisation
On behalf of Glenmark Pharmaceuticals SA
Eudract number
2014-001059-21
ISRCTN Number
n/a
Research summary
This is the first time the Study Drug will be given to humans. The study has been designed to assess how safe and well-tolerated the study drug is when given to healthy subjects (Part 1a); the effect of food on the study drug (Part 1b); how safe and well-tolerated the study drug is when given to healthy elderly subjects (Part 2); and to compare the effect of the study drug with the effect of a marketed drug, celecoxib (Part 3). In Parts 1 and 2 subjects will receive study drug or placebo, in Part 3 all subjects will receive study drug and celecoxib. In Parts 1 and 2 the subjects and staff will not know which treatment the subjects have been given i.e. they will be blinded. In Part 3 the subjects and staff will know which treatment the subjects have been given.
Cohorts A to F (Part1a) will include 8 healthy subjects. 6 will be treated with active drug and 2 with placebo. A minimum of 2 female subjects will be included in each of cohorts A – F (at least one female will receive study drug per cohort). Subjects in cohorts C and D will also take part in a second treatment period (Part 1b) in order to investigate the effects of food on the study drug. Cohort G (Part 2) will include 8 healthy elderly subjects. 6 will be treated with active and 2 with placebo. Cohort H (Part 3) will include 20 healthy volunteers who will take part in two treatment periods; in one they will receive Study Drug and in the other they will receive celecoxib. Up to 3 further cohorts of 8 subjects (6 active: 2 placebo) may be included in Parts 1 and 2. The study is expected to include 76 subjects in total.
REC name
North East - York Research Ethics Committee
REC reference
14/NE/0090
Date of REC Opinion
29 Apr 2014
REC opinion
Further Information Favourable Opinion