The objectives of the study will be to investigate the safety and pharmacokinetics of a single oral administration and a twice-daily multiple oral administration of CCX168 in Japanese healthy adult males; and to compare the pharmacokinetics of a single oral administration and a twice-daily multiple oral administration of CCX168 between Japanese and Caucasian healthy adult males.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
80
Sumida Hospital, SOUSEIKAI Global Clinical Research Center
Sumida City, Tokyo, Japan
Number of Participants Experiencing Adverse Events
Time frame: Up to 14 days
Number of Participants Experiencing Adverse Drug Reactions
Time frame: Up to 14 days
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
Time frame: Up to 14 days
Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Up to 14 days
Number of Participants Experiencing Clinically Significant Changes in Clinical Laboratory Parameters
Time frame: Up to 14 days
Maximum Plasma Concentration (Cmax) of CCX168
Time frame: Up to 14 days
Cmax of CCX168-M1 (Metabolite)
Time frame: Up to 14 days
Time of Cmax (tmax) of CCX168
Time frame: Up to 14 days
Tmax of CCX168-M1
Time frame: Up to 14 days
Area Under the Plasma Concentration Time Curve (AUC) from Time 0 to Infinity (AUC0-inf) of CCX168
Time frame: Up to 14 days
AUC0-inf of CCX168-M1
Time frame: Up to 14 days
AUC from Time 0 to Time of Last Measurable Plasma Concentration (AUC0-tz) of CCX168
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Time frame: Up to 14 days
AUC0-tz of CCX168-M1
Time frame: Up to 14 days
AUC During a Dosing Interval of CCX168
Time frame: Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7
AUC During a Dosing Interval of CCX168-M1
Time frame: Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7
Terminal Elimination Half-life of CCX168
Time frame: Up to 14 days
Terminal Elimination Half-life of CCX168-M1
Time frame: Up to 14 days
Apparent Oral Clearance of CCX168
Time frame: Up to 14 days
Apparent Volume of Distribution During the Terminal Phase of CCX168
Time frame: Up to 14 days
Mean Residence Time to Infinity of CCX168
Time frame: Up to 14 days
Accumulation Ratio of CCX168
Time frame: Cohorts B and D only: Up to 14 days
Accumulation Ratio of CCX168-M1
Time frame: Cohorts B and D only: Up to 14 days
Trough Plasma Concentration at the End of Dosing Interval of CCX168
Time frame: Cohorts B and D only: Up to 14 days
Trough Plasma Concentration at the End of Dosing Interval of CCX168-M1
Time frame: Cohorts B and D only: Up to 14 days