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

Phase 1CompletedNCT02361034

Glenmark Pharmaceuticals S.A.32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

GRC 27864DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Covance Clinical Research Unit Ltd

Leeds, Yorkshire, United Kingdom

Outcomes

Primary Outcomes

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

Maximum Concentration (Cmax) of GRC 27864 and its metabolite GRC 27884 following multiple doses in healthy adult subjects and elderly subjects.