Study Complete
Sponsor ID
CL007_168

A Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168

Sponsor ID
CL007_168
Clinicaltrials.gov ID
NCT05988021
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
16
Additional Study Details

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