Study Complete
Sponsor ID
CCX1101

A Study of CCX168 in Japanese and Caucasian Healthy Adult Males

Sponsor ID
CCX1101
Clinicaltrials.gov ID
NCT05988008
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
Single (Participant)
Enrollment
80
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants Experiencing Adverse Events

Timeframe: Up to 14 days

Number of Participants Experiencing Adverse Drug Reactions

Timeframe: Up to 14 days

Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters

Timeframe: Up to 14 days

Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters

Timeframe: Up to 14 days

Number of Participants Experiencing Clinically Significant Changes in Clinical Laboratory Parameters

Timeframe: Up to 14 days

Maximum Plasma Concentration (Cmax) of CCX168

Timeframe: Up to 14 days

Cmax of CCX168-M1 (Metabolite)

Timeframe: Up to 14 days

Time of Cmax (tmax) of CCX168

Timeframe: Up to 14 days

Tmax of CCX168-M1

Timeframe: Up to 14 days

Area Under the Plasma Concentration Time Curve (AUC) from Time 0 to Infinity (AUC0-inf) of CCX168

Timeframe: Up to 14 days

AUC0-inf of CCX168-M1

Timeframe: Up to 14 days

AUC from Time 0 to Time of Last Measurable Plasma Concentration (AUC0-tz) of CCX168

Timeframe: Up to 14 days

AUC0-tz of CCX168-M1

Timeframe: Up to 14 days

AUC During a Dosing Interval of CCX168

Timeframe: Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7

AUC During a Dosing Interval of CCX168-M1

Timeframe: Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7

Terminal Elimination Half-life of CCX168

Timeframe: Up to 14 days

Terminal Elimination Half-life of CCX168-M1

Timeframe: Up to 14 days

Apparent Oral Clearance of CCX168

Timeframe: Up to 14 days

Apparent Volume of Distribution During the Terminal Phase of CCX168

Timeframe: Up to 14 days

Mean Residence Time to Infinity of CCX168

Timeframe: Up to 14 days

Accumulation Ratio of CCX168

Timeframe: Cohorts B and D only: Up to 14 days

Accumulation Ratio of CCX168-M1

Timeframe: Cohorts B and D only: Up to 14 days

Trough Plasma Concentration at the End of Dosing Interval of CCX168

Timeframe: Cohorts B and D only: Up to 14 days

Trough Plasma Concentration at the End of Dosing Interval of CCX168-M1

Timeframe: Cohorts B and D only: Up to 14 days

Secondary Outcome Measures
Not Available

Locations

Location
Status
Contact Us
Location
Sumida Hospital, SOUSEIKAI Global Clinical Research Center
Sumida City, Tokyo, Japan, 130-0004
Status
Completed