Clinical trial NCT02179645: GRC 27864 First in Man, Single Ascending Dose Study in Healthy Volunteers
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Glenmark Pharmaceuticals Ltd. India
Sponsor class: INDUSTRY
Collaborators: name: Glenmark Pharmaceuticals S.A.
First posted: 2014-07-02
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Drug related adverse events (AEs) or any serious AEs
timeFrame: 15 days after administration of the study drug
Secondary outcomes:
measure: Time to Maximum Concentration (Tmax) of GRC 27864
timeFrame: Pre-dose to and post-dose from 15 minutes to 72 hours
measure: Maximum Concentration (Cmax) of GRC 27864
timeFrame: Post dose up to 72 hours
measure: Area Under Curve [(AUC (0-∞) and AUC (0-t)] of GRC 27864
timeFrame: Pre-dose to and post-dose from 15 minutes to 72 hours
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit
state: Yorkshire
Study officials:
affiliation: Medical Director
name: Jim Bush, MB ChB
role: PRINCIPAL_INVESTIGATOR
References: