Study Complete
Sponsor ID
CL008_168

A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 with Concomitant Medications

Sponsor ID
CL008_168
Clinicaltrials.gov ID
NCT06004947
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
32
Additional Study Details

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
Status
Contact Us
Location
Celerion
Tempe, Arizona, United States, 85283
Status
Completed