GRC 27864-102: MAD Study
Research type
Research Study
Full title
A Two-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 Pharmacokinetics of Multiple Ascending Doses in Healthy Subjects (Part 1), and of Multiple Doses in Elderly, Mild Hypertensive Subjects (Part 2)
IRAS ID
160561
Contact name
Jim Bush
Contact email
Sponsor organisation
Glenmark
Eudract number
2014-001932-13
Research summary
The study drug (GRC 27864) has been developed as a potential treatment for inflammatory pain.
Chronic pain is thought to affect more than 1.5 billion people worldwide and can lead to serious conditions, such as depression, inability to work, disrupted social relationships, and suicidal thoughts; these conditions in turn have a negative impact on the patient’s functional status and quality of life.
While a wide variety of painkillers are currently available, many patients still do not receive adequate relief or are unable to tolerate treatment due to side effects.
As of 25 June 2014, 24 healthy male and female volunteers have been given the Study Drug (in an ongoing clinical trial), as a single dose up to 100 mg. Single oral doses of 10, 30 and 100 mg were safe and well tolerated.
This study will be in 2 parts. Part 1 will involve healthy adult subjects while part 2 will involve elderly subjects with mildly raised blood pressure. In both parts, subjects will receive the study drug or a placebo for a period of 28 days. In part 1, dose levels will increase in subsequent groups after analysing safety data from the previous dose level. In part 2, the dose level selected will be decided after analysing the safety and drug exposure data from part 1.
Thirty-two subjects are planned to participate in this Study (including Parts 1 and 2) and additional groups may be added following review of the data. It is planned that 24 healthy subjects, aged between 18 and 55 years, will participate in Part 1 (in 3 separate groups) and 8 subjects, aged 65 years or older, with mild hypertension will participate in Part 2.
Subject participation is expected to last up to 10 weeks from the time of screening till the last post-study visit.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/1119
Date of REC Opinion
9 Sep 2014
REC opinion
Further Information Favourable Opinion