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Anti-neutrophil Cytoplasmic Antibody-associated VasculitisPhase 1NCT06004960

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

A Phase 1 study testing [14C]CCX168 in people with Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis, run by Amgen at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
What is being tested?
[14C]CCX168
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
20 Oct 2014to 5 Dec 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 16Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Covance Clinical Research Unit, Inc.

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official 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

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

Being tested
[14C]CCX168
Keywords
Vasculitis, Complement, C5aR, Vascular diseases, Cardiovascular diseases, Systemic lupus erythematosus
Medical subject headings
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Vasculitis, Vascular Diseases, Cardiovascular Diseases, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]CCX168Drug

    Administered orally.

Study groups in NCT06004960
Study groupRoleWhat they receive
[14C]CCX168ExperimentalParticipants will receive a single oral dose of [14C]CCX168 100 mg containing 400 μCi of [14C] on Day 1.
Receives: Drug: [14C]CCX168

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to Day 15

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

    Measured: Up to Day 15

Secondary outcomes (27)

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

    Measured: Up to Day 10

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

    Measured: Up to Day 10

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

    Measured: Up to Day 10

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

    Measured: Up to Day 10

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

    Measured: Up to Day 10

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Up to 24 hours

  10. Cmax of CCX168 and Metabolites in Plasma

    Measured: Up to Day 10

  11. Tmax of CCX168 and Metabolites in Plasma

    Measured: Up to Day 10

  12. λz of CCX168 and Metabolites in Plasma

    Measured: Up to Day 10

  13. t½z of CCX168 and Metabolites in Plasma

    Measured: Up to Day 10

  14. CL/F of CCX168 and Metabolites in Plasma

    Measured: Up to Day 10

  15. Vz/F of CCX168 and Metabolites in Plasma

    Measured: Up to Day 10

  16. AUC0-t of CCX168 and Metabolites in Plasma

    Measured: Up to Day 10

  17. AUCinf of CCX168 and Metabolites in Plasma

    Measured: Up to Day 10

  18. AUC0-24 of CCX168 and Metabolites in Plasma

    Measured: Up to 24 hours

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

    Measured: Up to Day 15

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

    Measured: Up to Day 15

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

    Measured: Up to Day 15

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

    Measured: Up to Day 15

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

    Measured: Up to Day 15

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

    Measured: Up to Day 15

  25. Number of Participants Experiencing Adverse Events (AEs)

    Measured: Up to Day 29

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

    Measured: Up to Day 29

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

    Measured: Up to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2023
  2. Study start20 Oct 2014
  3. Primary completion5 Dec 2014
  4. Study completion5 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06004960
Sponsor's protocol ID
CL004_168
Status last verified
Jul 2023
First submitted
15 Aug 2023
Last updated
22 Aug 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]CCX168 in people with Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis, run by Amgen at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Percentage of the Administered Dose of [14C]CCX168 Recovered in Urine (time frame: Up to Day 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06004960.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.

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