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To Evaluate Safety, Tolerability and Pharmacokinetics of GRC 27864 in Healthy Subjects and Elderly Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02361034
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
Glenmark Pharmaceuticals S.A.

Brief Summary:
This is a multiple Ascending dose (MAD) study with GRC 27864 in Healthy and Elderly Subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: GRC 27864 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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)
Study Start Date : January 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Active Comparator: GRC 27864
Test treatment GRC 27864
Drug: GRC 27864
Placebo Comparator: Placebo
Placebo treatment
Drug: Placebo



Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female subjects, aged ≥18 to <55 years (> 65 years for elderly cohort) at the time of informed consent
  2. Body mass index (BMI) within the range 18.5-32 kg/m2 (inclusive); weight must be >50 kg
  3. Subjects who are healthy and free from clinically significant illness or disease
  4. Females must be of non-childbearing potential, surgically sterile.
  5. Male subjects whose partners are of childbearing potential or have undergone tubal ligation must agree to use 2 highly effective methods of contraception

Exclusion Criteria:

  1. 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
  2. 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.
  3. Subjects with inherited or acquired disorders of platelet function, bleeding or coagulation.
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361034


Locations
United Kingdom
Covance Clinical Research Unit Ltd
Leeds, Yorkshire, United Kingdom, LS2 9LH
Sponsors and Collaborators
Glenmark Pharmaceuticals S.A.
Investigators
Principal Investigator: Jim Bush, MBChB, PhD Medical Director

Responsible Party: Glenmark Pharmaceuticals S.A.
ClinicalTrials.gov Identifier: NCT02361034     History of Changes
Other Study ID Numbers: GRC 27864-102
2014-001932-13 ( EudraCT Number )
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by Glenmark Pharmaceuticals S.A.:
Safety and pharmacokinetics of drug in healthy volunteers