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CompletedNCT06004960Updated Aug 22, 2023

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

A Phase 1 interventional study of [14C]CCX168 in Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis, sponsored by Amgen. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-22.

Sponsored by Amgen · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Dec 2014, 11 years 10 months ago, and no results have been posted to the registry.
  • Registered 8 years 9 months after the study started (first participant enrolled Oct 2014, registered Aug 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis

Keywords

  • Vasculitis
  • Complement
  • C5aR
  • Vascular diseases
  • Cardiovascular diseases
  • Systemic lupus erythematosus
03

In context

Vasculitis

230 studies on the registry are indexed under Vasculitis; 68 are open to participants now.

This study's enrollment of 6 is below the median of 48 across 119 interventional studies indexed under Vasculitis.

Browse Vasculitis studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Males, aged 18-55 years inclusive, who are in generally good health, whose body mass index is 19.0 to 30.0 kg/m\^2 inclusive;
  • Willing and able to give written Informed Consent and to comply with the requirements of the study protocol;
  • Negative result of the human immunodeficiency virus screen, the hepatitis B screen, and the hepatitis C screen;
  • Judged to be healthy by the Investigator, based on medical history, physical examination (including electrocardiogram), and clinical laboratory assessments. Participants with clinical laboratory values that are outside of normal limits and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance may be entered into the study;
  • Male participants with partners of childbearing potential may participate if adequate contraception is used during, and for 90 days after, any administration of study medication;
  • Males must refrain from sperm donation for 90 days following completion of the study;
  • Participants must have regular (at least once per day) bowel movements.

Exclusion criteria

Exclusion Criteria:

  • Participated in any studies where any radiolabeled drug was administered in the year prior to enrollment;
  • Received a diagnostic or therapeutic radiation dose (such as a barium meal, serial x-ray scan, or computed tomography scan) within 1 year of enrollment or are currently employed in a job requiring radiation exposure monitoring;
  • Expected requirement for use of any medication during the study period;
  • For at least 3 days prior to enrollment and throughout the blood sample collection period, participants will not be allowed to eat any food or drink any beverage containing alcohol, caffeine, grapefruit, grapefruit juice, Seville oranges, or charbroiled meat;
  • History within the three months prior to study entry of use of tobacco and/or nicotine containing products;
  • History within one year prior to study entry of illicit drug use;
  • History of alcohol abuse at any time in the past;
  • History of any form of cancer;
  • History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the participant at unacceptable risk for study participation;
  • Donated or lost more than 350 mL of blood or blood products within 56 days prior to screening, or donated plasma within 7 days of dosing;
  • Participant's hemoglobin less than 12 g/dL, confirmed by repeat measurement;
  • Participated in any clinical study of an investigational product within 30 days prior to dosing;
  • Participant has any evidence of hepatic disease; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or bilirubin greater than the upper limit of normal, unless considered not clinically significant by the Investigator;
  • Participant's white blood cell count is below the lower limit of normal at Screening or Check-in (Day -1), confirmed by repeat measurement;
  • Participant has any evidence of renal impairment; serum creatinine greater than the upper limit of normal, unless considered not clinically significant by the investigator;
  • Participant's urine tested positive at Screening and/or on Study Day -1 for any of the following: opioids, amphetamines and methamphetamines, cannabinoids, benzodiazepines, barbiturates, cocaine, cotinine, ecstasy, methadone, phencyclidine, tricyclic antidepressants, or alcohol Breathalyzer test allowed for alcohol).
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    [14C]CCX168

    Participants will receive a single oral dose of \[14C\]CCX168 100 mg containing 400 μCi of \[14C\] on Day 1.

    Drug: [14C]CCX168

Interventions

  • Drug[14C]CCX168

    Administered orally.

06

What researchers measure

Primary outcomes

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

    Time frame: Up to Day 15

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

    Time frame: Up to Day 15

Secondary outcomes

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

    Time frame: Up to Day 10

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

    Time frame: Up to Day 10

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

    Time frame: Up to Day 10

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

    Time frame: Up to Day 10

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

    Time frame: Up to Day 10

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

    Time frame: Up to Day 10

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

    Time frame: Up to Day 10

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

    Time frame: Up to Day 10

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

    Time frame: Up to 24 hours

  10. Cmax of CCX168 and Metabolites in Plasma

    Time frame: Up to Day 10

  11. Tmax of CCX168 and Metabolites in Plasma

    Time frame: Up to Day 10

  12. λz of CCX168 and Metabolites in Plasma

    Time frame: Up to Day 10

  13. t½z of CCX168 and Metabolites in Plasma

    Time frame: Up to Day 10

  14. CL/F of CCX168 and Metabolites in Plasma

    Time frame: Up to Day 10

  15. Vz/F of CCX168 and Metabolites in Plasma

    Time frame: Up to Day 10

  16. AUC0-t of CCX168 and Metabolites in Plasma

    Time frame: Up to Day 10

  17. AUCinf of CCX168 and Metabolites in Plasma

    Time frame: Up to Day 10

  18. AUC0-24 of CCX168 and Metabolites in Plasma

    Time frame: Up to 24 hours

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

    Time frame: Up to Day 15

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

    Time frame: Up to Day 15

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

    Time frame: Up to Day 15

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

    Time frame: Up to Day 15

  23. Renal Clearance (CLR) of [14C]CCX168

    Time frame: Up to Day 15

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

    Time frame: Up to Day 15

  25. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: Up to Day 29

  26. Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters

    Time frame: Up to Day 29

  27. Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters

    Time frame: Up to Day 29

07

Study locations

1 site
  • Covance Clinical Research Unit, Inc.
    Madison, Wisconsin 53704, United States
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06004960
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Aug 22, 2023
Start date
Oct 20, 2014
Primary completion
Dec 5, 2014
Completion
Dec 5, 2014
Last update
Aug 22, 2023

Study contacts

MD
study director · Amgen

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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