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

Primary Purpose

Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[14C]CCX168
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis focused on measuring Vasculitis, Complement, C5aR, Vascular diseases, Cardiovascular diseases, Systemic lupus erythematosus

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Covance Clinical Research Unit, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[14C]CCX168

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maximum Observed Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood
Time of Occurrence of Maximum Observed Concentration (Tmax) of Total Radioactivity in Plasma and Whole Blood
Elimination Rate Constant (λz) of Total Radioactivity in Plasma and Whole Blood
Apparent Terminal Half-life (t½z) of Total Radioactivity in Plasma and Whole Blood
Apparent Total Clearance (CL/F) of Total Radioactivity in Plasma and Whole Blood
Apparent Volume of Distribution (Vz/F) of Total Radioactivity in Plasma and Whole Blood
Area Under the Concentration-Time Curve from Time 0 to Time t (AUC0-t) of Total Radioactivity in Plasma and Whole Blood
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of Total Radioactivity in Plasma and Whole Blood
Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of Total Radioactivity in Plasma and Whole Blood
Cmax of CCX168 and Metabolites in Plasma
Tmax of CCX168 and Metabolites in Plasma
λz of CCX168 and Metabolites in Plasma
t½z of CCX168 and Metabolites in Plasma
CL/F of CCX168 and Metabolites in Plasma
Vz/F of CCX168 and Metabolites in Plasma
AUC0-t of CCX168 and Metabolites in Plasma
AUCinf of CCX168 and Metabolites in Plasma
AUC0-24 of CCX168 and Metabolites in Plasma
Percentage of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus
Percentage of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus
Amount of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus (Auinf + Afinf + Avinf)
Amount of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus (Amxuinf + Amxfinf + Amxvinf)
Renal Clearance (CLR) of [14C]CCX168
Renal Clearance of [14C]-Metabolite (CLRmx)
Number of Participants Experiencing Adverse Events (AEs)
Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters

Full Information

First Posted
August 15, 2023
Last Updated
August 15, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT06004960
Brief Title
A Study to Assess the Mass Balance Recovery (Absorption, Distribution, Metabolism and Excretion) of [14C]CCX168 in Healthy Participants
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2014 (Actual)
Primary Completion Date
December 5, 2014 (Actual)
Study Completion Date
December 5, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
Keywords
Vasculitis, Complement, C5aR, Vascular diseases, Cardiovascular diseases, Systemic lupus erythematosus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
[14C]CCX168
Arm Type
Experimental
Arm Description
Participants will receive a single oral dose of [14C]CCX168 100 mg containing 400 μCi of [14C] on Day 1.
Intervention Type
Drug
Intervention Name(s)
[14C]CCX168
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Cumulative Percentage of the Administered Dose of [14C]CCX168 Recovered in Urine
Time Frame
Up to Day 15
Title
Cumulative Percentage of the Administered Dose of [14C]CCX168 Recovered in Feces
Time Frame
Up to Day 15
Secondary Outcome Measure Information:
Title
Maximum Observed Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood
Time Frame
Up to Day 10
Title
Time of Occurrence of Maximum Observed Concentration (Tmax) of Total Radioactivity in Plasma and Whole Blood
Time Frame
Up to Day 10
Title
Elimination Rate Constant (λz) of Total Radioactivity in Plasma and Whole Blood
Time Frame
Up to Day 10
Title
Apparent Terminal Half-life (t½z) of Total Radioactivity in Plasma and Whole Blood
Time Frame
Up to Day 10
Title
Apparent Total Clearance (CL/F) of Total Radioactivity in Plasma and Whole Blood
Time Frame
Up to Day 10
Title
Apparent Volume of Distribution (Vz/F) of Total Radioactivity in Plasma and Whole Blood
Time Frame
Up to Day 10
Title
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
Title
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
Title
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
Title
Cmax of CCX168 and Metabolites in Plasma
Time Frame
Up to Day 10
Title
Tmax of CCX168 and Metabolites in Plasma
Time Frame
Up to Day 10
Title
λz of CCX168 and Metabolites in Plasma
Time Frame
Up to Day 10
Title
t½z of CCX168 and Metabolites in Plasma
Time Frame
Up to Day 10
Title
CL/F of CCX168 and Metabolites in Plasma
Time Frame
Up to Day 10
Title
Vz/F of CCX168 and Metabolites in Plasma
Time Frame
Up to Day 10
Title
AUC0-t of CCX168 and Metabolites in Plasma
Time Frame
Up to Day 10
Title
AUCinf of CCX168 and Metabolites in Plasma
Time Frame
Up to Day 10
Title
AUC0-24 of CCX168 and Metabolites in Plasma
Time Frame
Up to 24 hours
Title
Percentage of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus
Time Frame
Up to Day 15
Title
Percentage of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus
Time Frame
Up to Day 15
Title
Amount of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus (Auinf + Afinf + Avinf)
Time Frame
Up to Day 15
Title
Amount of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus (Amxuinf + Amxfinf + Amxvinf)
Time Frame
Up to Day 15
Title
Renal Clearance (CLR) of [14C]CCX168
Time Frame
Up to Day 15
Title
Renal Clearance of [14C]-Metabolite (CLRmx)
Time Frame
Up to Day 15
Title
Number of Participants Experiencing Adverse Events (AEs)
Time Frame
Up to Day 29
Title
Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
Time Frame
Up to Day 29
Title
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
Time Frame
Up to Day 29

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Healthy adult males will be enrolled.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Covance Clinical Research Unit, Inc.
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD Sharing URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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