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

NCT ID: NCT06004960

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-20
• Study Completion Date: 2014-12-05

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.

Conditions

Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

[14C]CCX168

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

Group Type: EXPERIMENTAL

[14C]CCX168

Intervention Type: DRUG

Administered orally.

Interventions

[14C]CCX168

Administered orally.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, United States

Countries

United States

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

CL004_168

Identifier Type: -

Identifier Source: org_study_id