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

NCT02179645 | Completed Phase 1

• 1 other identifier: GRC 27864-101
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

A Single Dose Study of GRC 27864 in Healthy Volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• 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

• Area Under Curve [(AUC (0-∞) and AUC (0-t)] of GRC 27864

  Pre-dose to and post-dose from 15 minutes to 72 hours

Study Arms (3)

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

GRC 27864 DRUG

GRC 27864

Celecoxib DRUG

Celecoxib

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glenmark Pharmaceuticals Ltd. India: lead
• Glenmark Pharmaceuticals S.A.: collaborator

Study Sites (1)

Covance Clinical Research Unit

Leeds, Yorkshire, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jim Bush, MB ChB

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: July 2, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 30, 2014

Record last verified: 2014-06

Locations

GB (1)