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

Healthy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361034
• Other study ID #: GRC 27864-102
• Secondary ID: 2014-001932-13
• Status: Completed
• Phase: Phase 1
• First received: February 3, 2015
• Last updated: December 14, 2015
• Start date: January 2015
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: Glenmark Pharmaceuticals S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GRC 27864

• Placebo

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit Ltd	Leeds	Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Glenmark Pharmaceuticals S.A.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of TEAEs and serious adverse events (SAEs) after multiple oral doses of GRC 27864 in healthy adult and elderly subjects		Baseline upto 42 days after administration of the study drug.	Yes
Secondary	Maximum Concentration (Cmax) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.		Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28	No
Secondary	Time to Maximum Concentration (Tmax) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.		Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28	No
Secondary	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.		Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28	No
Secondary	Half-life (t½) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.		Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28	No
Secondary	Volume of distribution (V)/bioavailability (F) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.		Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28	No
Secondary	Clearance (CL)/F of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.		Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28	No
Secondary	Observed accumulation ratio (Rac) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.		Predose and postdose from 0.25 to 48 hrs and from Day 1 to day 28	No
Secondary	Cerebrospinal fluid (CSF) concentrations of GRC 27864 and its metabolite GRC 27884 (CmaxCSF) following multiple doses to healthy adult subjects		6 hours, and 24 hours postdose on Day 26	No