Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-07 @ 3:14 AM
Study NCT ID:
NCT02361034
Status:
COMPLETED
Last Update Posted:
2015-12-15
First Post:
2015-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate Safety, Tolerability and Pharmacokinetics of GRC 27864 in Healthy Subjects and Elderly Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-14', 'studyFirstSubmitDate': '2015-02-03', 'studyFirstSubmitQcDate': '2015-02-06', 'lastUpdatePostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of TEAEs and serious adverse events (SAEs) after multiple oral doses of GRC 27864 in healthy adult and elderly subjects', 'timeFrame': 'Baseline upto 42 days after administration of the study drug.'}], 'secondaryOutcomes': [{'measure': 'Maximum Concentration (Cmax) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.', 'timeFrame': 'Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28'}, {'measure': 'Time to Maximum Concentration (Tmax) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.', 'timeFrame': 'Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28'}, {'measure': '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.', 'timeFrame': 'Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28'}, {'measure': 'Half-life (t½) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.', 'timeFrame': 'Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28'}, {'measure': 'Volume of distribution (V)/bioavailability (F) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.', 'timeFrame': 'Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28'}, {'measure': 'Clearance (CL)/F of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.', 'timeFrame': 'Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28'}, {'measure': 'Observed accumulation ratio (Rac) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.', 'timeFrame': 'Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28'}, {'measure': 'Cerebrospinal fluid (CSF) concentrations of GRC 27864 and its metabolite GRC 27884 (CmaxCSF) following multiple doses to healthy adult subjects', 'timeFrame': '6 hours, and 24 hours postdose on Day 26'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety and pharmacokinetics of drug in healthy volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a multiple Ascending dose (MAD) study with GRC 27864 in Healthy and Elderly Subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female subjects, aged ≥18 to \\<55 years (\\> 65 years for elderly cohort) at the time of informed consent\n2. Body mass index (BMI) within the range 18.5-32 kg/m2 (inclusive); weight must be \\>50 kg\n3. Subjects who are healthy and free from clinically significant illness or disease\n4. Females must be of non-childbearing potential, surgically sterile.\n5. Male subjects whose partners are of childbearing potential or have undergone tubal ligation must agree to use 2 highly effective methods of contraception\n\nExclusion Criteria:\n\n1. 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\n2. 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.\n3. Subjects with inherited or acquired disorders of platelet function, bleeding or coagulation.\n4. 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."}, 'identificationModule': {'nctId': 'NCT02361034', 'briefTitle': 'To Evaluate Safety, Tolerability and Pharmacokinetics of GRC 27864 in Healthy Subjects and Elderly Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glenmark Pharmaceuticals S.A.'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'GRC 27864-102'}, 'secondaryIdInfos': [{'id': '2014-001932-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GRC 27864', 'description': 'Test treatment GRC 27864', 'interventionNames': ['Drug: GRC 27864']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo treatment', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GRC 27864', 'type': 'DRUG', 'armGroupLabels': ['GRC 27864']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9LH', 'city': 'Leeds', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': 'Covance Clinical Research Unit Ltd', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Jim Bush, MBChB, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Director'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glenmark Pharmaceuticals S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}