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

Glenmark Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GRC 27864; Drug: Celecoxib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02179645

GRC 27864-101

Details and patient eligibility

About

A Single Dose Study of GRC 27864 in Healthy Volunteers.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 3 patient groups, including a placebo group

GRC 27864

Experimental group

Description:

Test Treatment GRC 27864

Treatment:

Drug: GRC 27864

Celecoxib

Active Comparator group

Description:

Active Comparator Treatment

Treatment:

Drug: Celecoxib

Placebo

Placebo Comparator group

Description:

Placebo Treatment

Treatment:

Drug: Placebo