A Single Dose Study of GRC 27864 in Healthy Volunteers.
This is a phase I study of GRC 27864 in healthy volunteers. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Participants will remain in the study for approximately 3 months. This study is for research purposes only and is not intended to treat any medical condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
76
Covance Clinical Research Unit
Leeds, Yorkshire, United Kingdom
Drug related adverse events (AEs) or any serious AEs
All treatment-emergent adverse events (TEAE) occurring in the study, in terms of nature, onset, duration, severity, relationship and outcome of adverse events and serious adverse events, in adult healthy volunteers from baseline to day 15.
Time frame: 15 days after administration of the study drug
Time to Maximum Concentration (Tmax) of GRC 27864
Time frame: Pre-dose to and post-dose from 15 minutes to 72 hours
Maximum Concentration (Cmax) of GRC 27864
Time frame: Post dose up to 72 hours
Area Under Curve [(AUC (0-∞) and AUC (0-t)] of GRC 27864
Time frame: Pre-dose to and post-dose from 15 minutes to 72 hours
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