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

Glenmark Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: GRC 27864

Study type

Interventional

Funder types

Industry

Identifiers

2014-001932-13 (EudraCT Number)

GRC 27864-102

Details and patient eligibility

About

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

Enrollment

32 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.