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Completed

NCT Number: NCT02361034

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

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Ltd

Leeds, Yorkshire, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

GRC 27864

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Glenmark Pharmaceuticals S.A.

Industry

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 11, 2015
Registry last updated
Dec 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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