HealthyPhase 1NCT02179645
GRC 27864 First in Man, Single Ascending Dose Study in Healthy Volunteers
A Phase 1 study testing GRC 27864 and Celecoxib in people with Healthy, run by Glenmark Pharmaceuticals Ltd. India at 1 site in United Kingdom.
Trial summary
A Single Dose Study of GRC 27864 in Healthy Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GRC 27864 and Celecoxib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical Research Unit
Leeds, Yorkshire, LS2 9LH
About this study
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.
A Single Dose Study of GRC 27864 in Healthy Volunteers.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRC 27864Drug
CelecoxibDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| GRC 27864 | Experimental | Test Treatment GRC 27864 Receives: Drug: GRC 27864 |
| Celecoxib | Active comparator | Active Comparator Treatment Receives: Drug: Celecoxib |
| Placebo | Placebo comparator | Placebo Treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days after administration of the study drug
Secondary outcomes (3)
Time to Maximum Concentration (Tmax) of GRC 27864
Measured: Pre-dose to and post-dose from 15 minutes to 72 hours
Maximum Concentration (Cmax) of GRC 27864
Measured: Post dose up to 72 hours
Area Under Curve [(AUC (0-∞) and AUC (0-t)] of GRC 27864
Measured: Pre-dose to and post-dose from 15 minutes to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. India
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals S.A.
- Responsible party
- Sponsor
- Investigators
- Jim Bush, MB ChB, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179645
- Sponsor's protocol ID
- GRC 27864-101
- Status last verified
- Jun 2014
- First submitted
- 26 Jun 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02179645
- Acronym / sponsor ID
- GRC 27864-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. IndiaIndustry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals S.A.
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GRC 27864 | Experimental | Drug: GRC 27864Test Treatment GRC 27864 |
| Celecoxib | Active comparator | Drug: CelecoxibActive Comparator Treatment |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRC 27864 | Drug | GRC 27864 |
| Celecoxib | Drug | Celecoxib |
| Placebo | Drug | Placebo |
Primary outcome
Drug related adverse events (AEs) or any serious AEs
Time frame: 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.
3 secondary outcomes
Time to Maximum Concentration (Tmax) of GRC 27864
Time frame: Pre-dose to and post-dose from 15 minutes to 72 hours
Maximum Concentration (Cmax) of GRC 27864
Time frame: Post dose up to 72 hours
Area Under Curve [(AUC (0-∞) and AUC (0-t)] of GRC 27864
Time frame: Pre-dose to and post-dose from 15 minutes to 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
Related trials for Healthy
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
Study of New Magnetic Resonance Imaging Methods of the Brain
Healthy Volunteer, Magnetic Resonance Imaging
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
RecruitingObservational study
Cytapheresis of Volunteer Donors
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Bush, MB ChB principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GRC 27864 and Celecoxib in people with Healthy, run by Glenmark Pharmaceuticals Ltd. India at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug related adverse events (AEs) or any serious AEs (time frame: 15 days after administration of the study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014; AzTrials last refreshed its copy on 30 Oct 2026.