A Study of CCX168 in Japanese and Caucasian Healthy Adult Males

NCT ID: NCT05988008

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-23
• Study Completion Date: 2018-09-20

Brief Summary

The objectives of the study will be to investigate the safety and pharmacokinetics of a single oral administration and a twice-daily multiple oral administration of CCX168 in Japanese healthy adult males; and to compare the pharmacokinetics of a single oral administration and a twice-daily multiple oral administration of CCX168 between Japanese and Caucasian healthy adult males.

Conditions

Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Cohort A: Single Oral Dosing of CCX168 in Japanese Adult Males

Healthy Japanese adult males will receive 1 of 3 single oral doses of CCX168 (10 mg, 30 mg or 100 mg) or placebo. Each dose level will be administered under fasted conditions. Single doses of CCX168 30 mg will be administered under fasted and fed conditions.

Group Type: EXPERIMENTAL

CCX168

Intervention Type: DRUG

Administered orally.

Placebo

Intervention Type: DRUG

Administered orally.

Cohort B: Multiple Oral Dosing of CCX168 in Japanese Adult Males

Healthy Japanese adult males will receive 1 of 2 oral doses of CCX168 (30 mg or 50 mg) or placebo twice-daily for 7 days under fed conditions.

Group Type: EXPERIMENTAL

CCX168

Intervention Type: DRUG

Administered orally.

Placebo

Intervention Type: DRUG

Administered orally.

Cohort C: Single Oral Dosing of CCX168 in Caucasian Adult Males

Healthy Caucasian adult males will receive 1 of 2 single oral doses of CCX168 (10 mg or 30 mg) or placebo under fasted conditions.

Group Type: EXPERIMENTAL

CCX168

Intervention Type: DRUG

Administered orally.

Placebo

Intervention Type: DRUG

Administered orally.

Cohort D: Multiple Oral Dosing of CCX168 in Caucasian Adult Males

Healthy Caucasian adult males will receive an oral dose of CCX168 30 mg or placebo twice-daily for 7 days under fed conditions.

Group Type: EXPERIMENTAL

CCX168

Intervention Type: DRUG

Administered orally.

Placebo

Intervention Type: DRUG

Administered orally.

Interventions

CCX168

Administered orally.

Intervention Type: DRUG

Placebo

Administered orally.

Intervention Type: DRUG

Other Intervention Names

Avacopan

Eligibility Criteria

Inclusion Criteria

• Japanese and Caucasian healthy males aged 20 to 45 years inclusive (at the time of obtaining informed consent);
• Body Mass Index (body weight [kg]/squared height [m^2]): 18.5 kg/m^2 or more and less than 25 kg/m^2 for Japanese males or between 18.5 and 29 kg/m^2 for Caucasian males (at the time of screening visit);
• Body weight: 50 kg or more and less than 90 kg (at the time of screening visit).

Exclusion Criteria

• Participants with any abnormal findings (e.g., clinical laboratory test values outside the reference range) during the physical examination and other tests (vital signs, 12-lead ECG and clinical laboratory tests) that are judged by the principal investigator or subinvestigator to be clinically significant;
• Participants who test positive for immunological tests (hepatitis B surface antigen, hepatitis C virus antibody, serological reaction of syphilis, and human immunodeficiency virus antigen and antibody);
• Participants with a history of drug allergy;
• Participants who are a habitual alcohol drinker with an average pure alcohol intake of over 40 g/day;
• Participants who test positive for abuse of phencyclidines, benzodiazepines, cocaine, stimulants, cannabis, morphine, barbiturates, and tricyclic antidepressants during urine drug testing;
• Male participant who do not agree to use adequate contraception for a period from a start of the investigational product administration to 12 weeks after the final administration of the investigational product;
• Participants with a QTcF intervals of 450 msec or greater in the 12-lead ECG at the time of the screening visit and/or Day -1;
• Participants who consumed tobacco or a nicotine patch/gum within 12 weeks prior to the investigational product administration;
• Participants who received other prescription medications or over-the-counter medications (including vitamins and energy drinks) within 2 weeks prior to the investigational product administration (excluding topical formulation that is not expected systemic action);
• Participants who received any supplements (Saint John's wort [Hypericum perforatum] etc.) that have been reported to affect the pharmacokinetics of concomitant use of drugs within 2 weeks prior to the investigational product administration;
• Participants who received a grapefruit and an orange that contain the component inhibiting CYP3A4 or the food and drink containing these fruits within 1 week prior to the investigational product administration;
• Participants who received other investigational products within 16 weeks prior to the investigational product administration;
• Participants who donated more than 200 mL of blood (donation of whole blood, plasma components or platelets, etc.) within 4 weeks or more than 400 mL within 16 weeks prior to the investigational product administration;
• Participants who performed excessive exercise with symptoms of fatigue or muscle pain within 1 week prior to the investigational product administration;
• Participants who are judged by the principal investigator or subinvestigator as inappropriate for inclusion in this study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 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

Sumida Hospital, SOUSEIKAI Global Clinical Research Center

Sumida City, Tokyo, Japan

Countries

Japan

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

CCX1101

Identifier Type: -

Identifier Source: org_study_id