GRC 27864 First in Man, Single Ascending Dose Study in He... | NCT02179645

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

NCT02179645

Sponsor

Glenmark Pharmaceuticals Ltd. India

Status

Completed

Last Update Posted

Dec 30, 2014Estimated

Enrollment

76Actual

Phase

Phase 1

Conditions

Healthy

Interventions

GRC 27864
Celecoxib
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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.

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jun 26, 2014

First Submission Date that Met QC Criteria

Jun 30, 2014

First Posted Date

Jul 2, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2014

Last Update Posted Date

Dec 30, 2014Estimated

Name	Class
Glenmark Pharmaceuticals S.A.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GRC 27864	Experimental	Test Treatment GRC 27864	Drug: GRC 27864
Celecoxib	Active Comparator	Active Comparator Treatment	Drug: Celecoxib
Placebo	Placebo Comparator	Placebo Treatment	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GRC 27864	Drug		GRC 27864
Celecoxib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Time to Maximum Concentration (Tmax) of GRC 27864		Pre-dose to and post-dose from 15 minutes to 72 hours
Maximum Concentration (Cmax) of GRC 27864		Post dose up to 72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female healthy subjects, age ≥18 to ≤55 years (≥65 years for elderly subjects study) at the time of informed consent
Body mass index between 18.5 and 32.0 kilograms per square meter (kg/m2), inclusive
Female subjects who are of child-bearing potential or had tubal ligation must agree to use highly effective methods of contraception
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:

Subjects with inherited or acquired disorders in platelet function, bleeding or coagulation.
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.
Veins unsuitable for repeat venepuncture.
Presence of clinical laboratory test values judged clinically significant by the investigator.
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.
History or presence of drug abuse at screening or upon admission to the CRU.
Participation in another clinical study with an experimental drug within 3 months before the first administration of the IMP.
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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals