Study Complete
Sponsor ID
CL004_168

A Study to Assess the Mass Balance Recovery (Absorption, Distribution, Metabolism and Excretion) of [14C]CCX168 in Healthy Participants

Sponsor ID
CL004_168
Clinicaltrials.gov ID
NCT06004960
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of this study is to perform mass balance following a single oral dose of [14C]CCX168 in healthy adult male participants.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
6
Additional Study Details

Protocol Summary

Primary Outcome Measures

Cumulative Percentage of the Administered Dose of [14C]CCX168 Recovered in Urine

Timeframe: Up to Day 15

Cumulative Percentage of the Administered Dose of [14C]CCX168 Recovered in Feces

Timeframe: Up to Day 15

Secondary Outcome Measures

Maximum Observed Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood

Timeframe: Up to Day 10

Time of Occurrence of Maximum Observed Concentration (Tmax) of Total Radioactivity in Plasma and Whole Blood

Timeframe: Up to Day 10

Elimination Rate Constant (λz) of Total Radioactivity in Plasma and Whole Blood

Timeframe: Up to Day 10

Apparent Terminal Half-life (t½z) of Total Radioactivity in Plasma and Whole Blood

Timeframe: Up to Day 10

Apparent Total Clearance (CL/F) of Total Radioactivity in Plasma and Whole Blood

Timeframe: Up to Day 10

Apparent Volume of Distribution (Vz/F) of Total Radioactivity in Plasma and Whole Blood

Timeframe: Up to Day 10

Area Under the Concentration-Time Curve from Time 0 to Time t (AUC0-t) of Total Radioactivity in Plasma and Whole Blood

Timeframe: Up to Day 10

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of Total Radioactivity in Plasma and Whole Blood

Timeframe: Up to Day 10

Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of Total Radioactivity in Plasma and Whole Blood

Timeframe: Up to 24 hours

Cmax of CCX168 and Metabolites in Plasma

Timeframe: Up to Day 10

Tmax of CCX168 and Metabolites in Plasma

Timeframe: Up to Day 10

λz of CCX168 and Metabolites in Plasma

Timeframe: Up to Day 10

t½z of CCX168 and Metabolites in Plasma

Timeframe: Up to Day 10

CL/F of CCX168 and Metabolites in Plasma

Timeframe: Up to Day 10

Vz/F of CCX168 and Metabolites in Plasma

Timeframe: Up to Day 10

AUC0-t of CCX168 and Metabolites in Plasma

Timeframe: Up to Day 10

AUCinf of CCX168 and Metabolites in Plasma

Timeframe: Up to Day 10

AUC0-24 of CCX168 and Metabolites in Plasma

Timeframe: Up to 24 hours

Percentage of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus

Timeframe: Up to Day 15

Percentage of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus

Timeframe: Up to Day 15

Amount of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus (Auinf + Afinf + Avinf)

Timeframe: Up to Day 15

Amount of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus (Amxuinf + Amxfinf + Amxvinf)

Timeframe: Up to Day 15

Renal Clearance (CLR) of [14C]CCX168

Timeframe: Up to Day 15

Renal Clearance of [14C]-Metabolite (CLRmx)

Timeframe: Up to Day 15

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 29

Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters

Timeframe: Up to Day 29

Locations

Location
Status
Contact Us
Location
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, United States, 53704
Status
Completed