Study Complete
Sponsor ID
CL007_168
A Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168
Study Details
The primary objective of this clinical trial is to evaluate the effect of a high-fat, high-calorie meal on the pharmacokinetic (PK) profile of CCX168, following oral administration of a single dose of 30 mg CCX168 to healthy volunteers.
Protocol Summary
Primary Outcome Measures
Maximum Plasma Concentration (Cmax) of CCX168
Timeframe: Up to 35 days
Time of Cmax (Tmax) of CCX168
Timeframe: Up to 35 days
Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t (AUC0-t)
Timeframe: Up to 35 days
AUC of CCX168 From Time 0 to Infinity (AUC0-inf)
Timeframe: Up to 35 days
Secondary Outcome Measures
Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Timeframe: Up to 35 days
Number of Participants Experiencing Adverse Events (AEs)
Timeframe: Up to 35 days
Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
Timeframe: Up to 35 days
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
Timeframe: Up to 35 days
Locations
Location
Celerion
Tempe, Arizona, United States, 85283
Status
Completed