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CompletedNCT02361034Updated Dec 15, 2015

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

A Phase 1 interventional study of GRC 27864 and Placebo in Healthy, sponsored by Glenmark Pharmaceuticals S.A.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-15.

Sponsored by Glenmark Pharmaceuticals S.A. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • Safety and pharmacokinetics of drug in healthy volunteers
03

In context

Lead sponsor

This is the only study on the registry with Glenmark Pharmaceuticals S.A. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    GRC 27864

    Test treatment GRC 27864

    Drug: GRC 27864

  • Placebo comparator
    Placebo

    Placebo treatment

    Drug: Placebo

Interventions

  • DrugGRC 27864
  • DrugPlacebo
06

What researchers measure

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

07

Study locations

1 site
  • Covance Clinical Research Unit Ltd
    Leeds, Yorkshire LS2 9LH, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02361034
Lead sponsor
Glenmark Pharmaceuticals S.A.
Responsible party
Sponsor
First posted
Feb 11, 2015
Start date
Jan 2015
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Dec 15, 2015

Study contacts

Jim Bush, MBChB, PhD
principal investigator · Medical Director

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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