Clinical trial NCT06004960: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
Keywords: Vasculitis
Complement
C5aR
Vascular diseases
Cardiovascular diseases
Systemic lupus erythematosus
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-08-22
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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).

Primary outcomes:
measure: Cumulative Percentage of the Administered Dose of [14C]CCX168 Recovered in Urine
timeFrame: Up to Day 15
measure: Cumulative Percentage of the Administered Dose of [14C]CCX168 Recovered in Feces
timeFrame: Up to Day 15
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood
timeFrame: Up to Day 10
measure: Time of Occurrence of Maximum Observed Concentration (Tmax) of Total Radioactivity in Plasma and Whole Blood
timeFrame: Up to Day 10
measure: Elimination Rate Constant (λz) of Total Radioactivity in Plasma and Whole Blood
timeFrame: Up to Day 10
measure: Apparent Terminal Half-life (t½z) of Total Radioactivity in Plasma and Whole Blood
timeFrame: Up to Day 10
measure: Apparent Total Clearance (CL/F) of Total Radioactivity in Plasma and Whole Blood
timeFrame: Up to Day 10
measure: Apparent Volume of Distribution (Vz/F) of Total Radioactivity in Plasma and Whole Blood
timeFrame: Up to Day 10
measure: 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
measure: 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
measure: 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
measure: Cmax of CCX168 and Metabolites in Plasma
timeFrame: Up to Day 10
measure: Tmax of CCX168 and Metabolites in Plasma
timeFrame: Up to Day 10
measure: λz of CCX168 and Metabolites in Plasma
timeFrame: Up to Day 10
measure: t½z of CCX168 and Metabolites in Plasma
timeFrame: Up to Day 10
measure: CL/F of CCX168 and Metabolites in Plasma
timeFrame: Up to Day 10
measure: Vz/F of CCX168 and Metabolites in Plasma
timeFrame: Up to Day 10
measure: AUC0-t of CCX168 and Metabolites in Plasma
timeFrame: Up to Day 10
measure: AUCinf of CCX168 and Metabolites in Plasma
timeFrame: Up to Day 10
measure: AUC0-24 of CCX168 and Metabolites in Plasma
timeFrame: Up to 24 hours
measure: Percentage of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus
timeFrame: Up to Day 15
measure: Percentage of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus
timeFrame: Up to Day 15
measure: Amount of Unchanged [14C]CCX168 Recovered in Urine, Feces, and Vomitus (Auinf + Afinf + Avinf)
timeFrame: Up to Day 15
measure: Amount of [14C]-Metabolite Recovered in Urine, Feces, and Vomitus (Amxuinf + Amxfinf + Amxvinf)
timeFrame: Up to Day 15
measure: Renal Clearance (CLR) of [14C]CCX168
timeFrame: Up to Day 15
measure: Renal Clearance of [14C]-Metabolite (CLRmx)
timeFrame: Up to Day 15
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to Day 29
measure: Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
timeFrame: Up to Day 29
measure: Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
timeFrame: Up to Day 29
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Wisconsin
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: