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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001932-13 | EudraCT Number |
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This is a multiple Ascending dose (MAD) study with GRC 27864 in Healthy and Elderly Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GRC 27864 | Active Comparator | Test treatment GRC 27864 |
|
| Placebo | Placebo Comparator | Placebo treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GRC 27864 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim Bush, MBChB, PhD | Medical Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Ltd | Leeds | Yorkshire | LS2 9LH | United Kingdom |
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| 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 |
| 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 |
| 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 |
| 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 |