NCT02179645

GRC 27864 First in Man, Single Ascending Dose Study in Healthy Volunteers

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Glenmark Pharmaceuticals Ltd. India · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Single Dose Study of GRC 27864 in Healthy Volunteers.

Detailed description

This is a phase I study of GRC 27864 in healthy volunteers. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Participants will remain in the study for approximately 3 months. This study is for research purposes only and is not intended to treat any medical condition.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GRC 27864
DRUG	Celecoxib
DRUG	Placebo

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-07-02
• Last updated: 2014-12-30

Locations

1 site across 1 country: United Kingdom