NCT02361034

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2015

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

8 months

First QC Date

February 3, 2015

Last Update Submit

December 14, 2015

Conditions

Healthy

Keywords

Safety and pharmacokinetics of drug in healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • +3 more secondary outcomes

Study Arms (2)

GRC 27864

ACTIVE COMPARATOR

Test treatment GRC 27864

Drug: GRC 27864

Placebo

PLACEBO COMPARATOR

Placebo treatment

Drug: Placebo

Interventions

GRC 27864DRUG
GRC 27864
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit Ltd

Leeds, Yorkshire, LS2 9LH, United Kingdom

Location

Study Officials

  • Jim Bush, MBChB, PhD

    Medical Director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 11, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

December 15, 2015

Record last verified: 2015-12

Locations

GB(1)