Study Complete
Sponsor ID
CL008_168
A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 with Concomitant Medications
Study Details
The primary objective of this study will be to evaluate the drug-drug interaction potential of CCX168 with concomitant medications, as either a perpetrator or a victim, following oral administration of CCX168 to healthy participants.
Protocol Summary
Primary Outcome Measures
Cohort A: Maximum Plasma Concentration (Cmax) of Midazolam
Timeframe: Up to Day 13
Cohort A: Cmax of Celecoxib
Timeframe: Up to Day 13
Cohort A: Time of Cmax (Tmax) of Midazolam
Timeframe: Up to Day 13
Cohort A: Tmax of Celecoxib
Timeframe: Up to Day 13
Cohort A: Area under the plasma concentration-time curve (AUC) from Time 0 to infinity of Midazolam
Timeframe: Up to Day 13
Cohort A: AUC from Time 0 to infinity of Celecoxib
Timeframe: Up to Day 13
Cohort A: Apparent Terminal Half Life of Midazolam
Timeframe: Up to Day 13
Cohort A: Apparent Terminal Half Life of Celecoxib
Timeframe: Up to Day 13
Cohort A: Cmax of CCX168
Timeframe: Day 15 up to Day 19
Cohort A: Tmax of CCX168
Timeframe: Day 15 up to Day 19
Cohort A: AUC Over the Dosing Interval of CCX168
Timeframe: Day 15 up to Day 19
Cohort B: Cmax of CCX168
Timeframe: Up to Day 14
Cohort B: Tmax of CCX168
Timeframe: Up to Day 14
Cohort B: AUC from Time 0 to infinity of CCX168
Timeframe: Up to Day 14
Cohort B: Apparent Terminal Half Life of CCX168
Timeframe: Up to Day 14
Secondary Outcome Measures
Number of Participants Experiencing Adverse Events (AEs)
Timeframe: Up to Day 29
Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
Timeframe: Up to Day 19
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
Timeframe: Up to Day 19
Locations
Location
Celerion
Tempe, Arizona, United States, 85283
Status
Completed