A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants
Study Details
The primary objective of this study will be to evaluate the safety and tolerability of single and multiple oral doses of CCX168, over a range of dose levels, in healthy male and female participants.
Protocol Summary
Number of Participants Experiencing Adverse Events (AEs)
Timeframe: Up to 43 days
Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
Timeframe: Up to 29 days
Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Timeframe: Up to 29 days
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
Timeframe: Up to 29 days
Maximum Plasma Concentration (Cmax) of CCX168
Timeframe: Period 1: Up to Day 8; Period 2: Up to Day 15
Time of Cmax of CCX168
Timeframe: Period 1: Up to Day 8; Period 2: Up to Day 15
Terminal Phase Rate Constant of CCX168
Timeframe: Period 1: Up to Day 8; Period 2: Up to Day 15
Apparent Terminal Half-life of CCX168
Timeframe: Period 1: Up to Day 8; Period 2: Up to Day 15
Apparent Oral Clearance of CCX168
Timeframe: Period 1: Up to Day 8; Period 2: Up to Day 15
Apparent Volume of Distribution of CCX168
Timeframe: Period 1: Up to Day 8; Period 2: Up to Day 15
Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t
Timeframe: Period 1: Up to Day 8; Period 2: Up to Day 15
AUC of CCX168 From Time 0 to Infinity
Timeframe: Period 1: Up to Day 8; Period 2: Up to Day 15
AUC of CCX168 From Time 0 to 24 Hours
Timeframe: Periods 1 and 2: Up to Hour 24
AUC of CCX168 From Time 0 to 12 Hours
Timeframe: Periods 1 and 2: Up to Hour 12
AUC of CCX168 From Time 12 to 24 Hours
Timeframe: Periods 1 and 2: Hour 12 to Hour 24
Period 2: AUC of CCX168 From Time 0 to the end of the Dosing Interval
Timeframe: Cohorts 1-3: Up to Hour 24; Cohorts 4-5: Up to Hour 12
Period 2: Accumulation Ratio of CCX168
Timeframe: Up to Day 7
Percent Inhibition of complement 5a receptor (C5aR)-dependent Upregulation of CD11b in Peripheral Blood Neutrophils
Timeframe: Period 1: Up to Hour 24; Period 2: Up to 12 hours after the first dose on Day 7