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

NCT ID: NCT02361034

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-09-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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Safety and pharmacokinetics of drug in healthy volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GRC 27864

Test treatment GRC 27864

Group Type ACTIVE_COMPARATOR

GRC 27864

Intervention Type DRUG

Placebo

Placebo treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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GRC 27864

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Glenmark Pharmaceuticals S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jim Bush, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Director

Locations

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Covance Clinical Research Unit Ltd

Leeds, Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2014-001932-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GRC 27864-102

Identifier Type: -

Identifier Source: org_study_id