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Completed

NCT Number: NCT06004960

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

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

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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).

Treatment and study plan

[14C]CCX168

Drug

Administered orally.

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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

An Open-Label, Phase 1 Study in Healthy Volunteers to Evaluate the Mass Balance Recovery and Metabolic Disposition of a Single Oral Dose of [14C]CCX168

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 22, 2023
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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