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

Healthy Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179645
• Other study ID #: GRC 27864-101
• Status: Completed
• Phase: Phase 1
• First received: June 26, 2014
• Last updated: December 29, 2014
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2014
• Source: Glenmark Pharmaceuticals Ltd. India
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

A Single Dose Study of GRC 27864 in Healthy Volunteers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Male or female healthy subjects, age =18 to =55 years (=65 years for elderly subjects study) at the time of informed consent

2. Body mass index between 18.5 and 32.0 kilograms per square meter (kg/m2), inclusive

3. Female subjects who are of child-bearing potential or had tubal ligation must agree to use highly effective methods of contraception

4. Male subjects whose partners are of child-bearing potential or had tubal ligation must also agree to use two highly effective method of contraception

Exclusion Criteria:

1. Subjects with inherited or acquired disorders in platelet function, bleeding or coagulation.

2. Presence of any clinically relevant acute or chronic disease which could interfere with the subject safety during the clinical study, expose the subject to undue risk.

3. Veins unsuitable for repeat venepuncture.

4. Presence of clinical laboratory test values judged clinically significant by the investigator.

5. Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV)-1 and/or -2 antibodies at screening.

6. History or presence of drug abuse at screening or upon admission to the CRU.

7. Participation in another clinical study with an experimental drug within 3 months before the first administration of the IMP.

8. Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent, or limit the ability of the subject to comply with the Clinical Study Protocol requirements.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GRC 27864

• Celecoxib

• Placebo

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit	Leeds	Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Glenmark Pharmaceuticals Ltd. India	Glenmark Pharmaceuticals S.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug related adverse events (AEs) or any serious AEs	All treatment-emergent adverse events (TEAE) occurring in the study, in terms of nature, onset, duration, severity, relationship and outcome of adverse events and serious adverse events, in adult healthy volunteers from baseline to day 15.	15 days after administration of the study drug	Yes
Secondary	Time to Maximum Concentration (Tmax) of GRC 27864		Pre-dose to and post-dose from 15 minutes to 72 hours	No
Secondary	Maximum Concentration (Cmax) of GRC 27864		Post dose up to 72 hours	No
Secondary	Area Under Curve [(AUC (0-8) and AUC (0-t)] of GRC 27864		Pre-dose to and post-dose from 15 minutes to 72 hours	No