HealthyPhase 1NCT02361034
To Evaluate Safety, Tolerability and Pharmacokinetics of GRC 27864 in Healthy Subjects and Elderly Healthy Subjects
A Phase 1 study testing GRC 27864 in people with Healthy, run by Glenmark Pharmaceuticals S.A. at 1 site in United Kingdom.
Trial summary
This is a multiple Ascending dose (MAD) study with GRC 27864 in Healthy and Elderly Subjects. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Sep 2015
- 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 subjects, aged ≥18 to <55 years (> 65 years for elderly cohort) at the time of informed consent
- Body mass index (BMI) within the range 18.5-32 kg/m2 (inclusive); weight must be >50 kg
- Subjects who are healthy and free from clinically significant illness or disease
- Females must be of non-childbearing potential, surgically sterile.
- Male subjects whose partners are of childbearing potential or have undergone tubal ligation must agree to use 2 highly effective methods of contraception
Who cannot join
- Systolic blood pressure (SBP) <90 mmHg or >140 mmHg, diastolic blood pressure (DBP) <45 mmHg or >90 mmHg, resting pulse rate <40 beats per minute (bpm) or >100 bpm
- Subjects who have the presence of active peptic ulcer disease, gastrointestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease, chronic diarrhoea or positive 13C urea breath/faecal test for Helicobacter pylori at Screening.
- Subjects with inherited or acquired disorders of platelet function, bleeding or coagulation.
- Presence of any clinically relevant acute or chronic disease that could interfere with the subject's safety during the clinical study, expose the subject to undue risk.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical Research Unit Ltd
Leeds, Yorkshire, LS2 9LH
About this study
Official title: A Two-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 Pharmacokinetics of Multiple Ascending Doses in Healthy Subjects (Part 1), and of Multiple Doses in Elderly Subjects (Part 2)
This is a multiple Ascending dose (MAD) study with GRC 27864 in Healthy and Elderly Subjects.
- Conditions
- Healthy
- Being tested
- GRC 27864, Placebo
- Keywords
- Safety and pharmacokinetics of drug in healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRC 27864Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| GRC 27864 | Active comparator | Test treatment GRC 27864 Receives: Drug: GRC 27864 |
| 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.
Number of TEAEs and serious adverse events (SAEs) after multiple oral doses of GRC 27864 in healthy adult and elderly subjects
Measured: Baseline upto 42 days after administration of the study drug.
Secondary outcomes (8)
Maximum Concentration (Cmax) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.
Measured: Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28
Time to Maximum Concentration (Tmax) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.
Measured: Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28
Area Under Curve [AUC0-t and AUC0-tau] of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.
Measured: Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28
Half-life (t½) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.
Measured: Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28
Volume of distribution (V)/bioavailability (F) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.
Measured: Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28
Clearance (CL)/F of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.
Measured: Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28
Observed accumulation ratio (Rac) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.
Measured: Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28
Cerebrospinal fluid (CSF) concentrations of GRC 27864 and its metabolite GRC 27884 (CmaxCSF) following multiple doses to healthy adult subjects
Measured: 6 hours, and 24 hours postdose on Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glenmark Pharmaceuticals S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Bush, MBChB, PhD, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361034
- Sponsor's protocol ID
- GRC 27864-102
- Other IDs
- 2014-001932-13, 2014
- Status last verified
- Dec 2015
- First submitted
- 3 Feb 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-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 Pharmacokinetics of Multiple Ascending Doses in Healthy Subjects (Part 1), and of Multiple Doses in Elderly Subjects (Part 2)
- ClinicalTrials.gov ID
- NCT02361034
- Acronym / sponsor ID
- GRC 27864-102
- Conditions
- Healthy
- Keywords
- Safety and pharmacokinetics of drug in healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Glenmark Pharmaceuticals S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 11 Feb 2015 (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.
This is a multiple Ascending dose (MAD) study with GRC 27864 in Healthy and Elderly Subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GRC 27864 | Active comparator | Drug: GRC 27864Test treatment GRC 27864 |
| 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 (5 listed)
- Male or female subjects, aged ≥18 to <55 years (> 65 years for elderly cohort) at the time of informed consent
- Body mass index (BMI) within the range 18.5-32 kg/m2 (inclusive); weight must be >50 kg
- Subjects who are healthy and free from clinically significant illness or disease
- Females must be of non-childbearing potential, surgically sterile.
- Male subjects whose partners are of childbearing potential or have undergone tubal ligation must agree to use 2 highly effective methods of contraception
Key exclusion criteria (4 listed)
- Systolic blood pressure (SBP) <90 mmHg or >140 mmHg, diastolic blood pressure (DBP) <45 mmHg or >90 mmHg, resting pulse rate <40 beats per minute (bpm) or >100 bpm
- Subjects who have the presence of active peptic ulcer disease, gastrointestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease, chronic diarrhoea or positive 13C urea breath/faecal test for Helicobacter pylori at Screening.
- Subjects with inherited or acquired disorders of platelet function, bleeding or coagulation.
- Presence of any clinically relevant acute or chronic disease that could interfere with the subject's safety during the clinical study, expose the subject to undue risk.
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 |
| Placebo | Drug | Placebo |
Primary outcome
Number of TEAEs and serious adverse events (SAEs) after multiple oral doses of GRC 27864 in healthy adult and elderly subjects
Time frame: Baseline upto 42 days after administration of the study drug.
8 secondary outcomes
Maximum Concentration (Cmax) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.
Time frame: Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28
Time to Maximum Concentration (Tmax) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.
Time frame: Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28
Area Under Curve [AUC0-t and AUC0-tau] of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.
Time frame: Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28
Half-life (t½) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.
Time frame: Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28
Volume of distribution (V)/bioavailability (F) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.
Time frame: Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28
Clearance (CL)/F of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.
Time frame: Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28
Observed accumulation ratio (Rac) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.
Time frame: Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28
Cerebrospinal fluid (CSF) concentrations of GRC 27864 and its metabolite GRC 27884 (CmaxCSF) following multiple doses to healthy adult subjects
Time frame: 6 hours, and 24 hours postdose on Day 26
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 15 Dec 2015.
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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, MBChB, PhD 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 in people with Healthy, run by Glenmark Pharmaceuticals S.A. 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 5 inclusion and 4 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 15 Dec 2015. 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?
Number of TEAEs and serious adverse events (SAEs) after multiple oral doses of GRC 27864 in healthy adult and elderly subjects (time frame: Baseline upto 42 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 15 Dec 2015.