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

NCT ID: NCT02179645

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-12-31

Brief Summary

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A Single Dose Study of GRC 27864 in Healthy Volunteers.

Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GRC 27864

Test Treatment GRC 27864

Group Type EXPERIMENTAL

GRC 27864

Intervention Type DRUG

Celecoxib

Active Comparator Treatment

Group Type ACTIVE_COMPARATOR

Celecoxib

Intervention Type DRUG

Placebo

Placebo Treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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GRC 27864

Intervention Type DRUG

Celecoxib

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Glenmark Pharmaceuticals S.A.

INDUSTRY

Sponsor Role collaborator

Glenmark Pharmaceuticals Ltd. India

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jim Bush, MB ChB

Role: PRINCIPAL_INVESTIGATOR

Medical Director

Locations

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Covance Clinical Research Unit

Leeds, Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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GRC 27864-101

Identifier Type: -

Identifier Source: org_study_id