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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: GRC 27864; Drug: Celecoxib

• Registration Number: NCT02179645
• Lead Sponsor: Glenmark Pharmaceuticals Ltd. India

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.

Study Timeline

• Study Start: 2014-05
• Status Verified: 2014-06
• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-06-30
• Study First Posted: 2014-07-02
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-29
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Treatment
GRC 27864	GRC 27864	Test Treatment GRC 27864
Celecoxib	Celecoxib	Active Comparator Treatment

Primary Outcome Measures

Name	Time	Method
Drug related adverse events (AEs) or any serious AEs	15 days after administration of the study drug	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Covance Clinical Research Unit; 🇬🇧 Leeds, Yorkshire, United Kingdom