A Study of CCX168 in Japanese and Caucasian Healthy Adult Males

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT05988008

Collaborator

(none)

Enrollment

Location

Arms

10.9

Actual Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis	Drug: CCX168 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

A Phase I Clinical Study of CCX168 in Japanese and Caucasian Healthy Adult Males

Actual Study Start Date :

Oct 23, 2017

Actual Primary Completion Date :

Jan 26, 2018

Actual Study Completion Date :

Sep 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: CCX168 Administered orally. Other Names: Avacopan Drug: Placebo Administered orally.
Experimental: 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.	Drug: CCX168 Administered orally. Other Names: Avacopan Drug: Placebo Administered orally.
Experimental: 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.	Drug: CCX168 Administered orally. Other Names: Avacopan Drug: Placebo Administered orally.
Experimental: 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.	Drug: CCX168 Administered orally. Other Names: Avacopan Drug: Placebo Administered orally.

Outcome Measures

Primary Outcome Measures

Number of Participants Experiencing Adverse Events [Up to 14 days]
Number of Participants Experiencing Adverse Drug Reactions [Up to 14 days]
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters [Up to 14 days]
Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters [Up to 14 days]
Number of Participants Experiencing Clinically Significant Changes in Clinical Laboratory Parameters [Up to 14 days]
Maximum Plasma Concentration (Cmax) of CCX168 [Up to 14 days]
Cmax of CCX168-M1 (Metabolite) [Up to 14 days]
Time of Cmax (tmax) of CCX168 [Up to 14 days]
Tmax of CCX168-M1 [Up to 14 days]
Area Under the Plasma Concentration Time Curve (AUC) from Time 0 to Infinity (AUC0-inf) of CCX168 [Up to 14 days]
AUC0-inf of CCX168-M1 [Up to 14 days]
AUC from Time 0 to Time of Last Measurable Plasma Concentration (AUC0-tz) of CCX168 [Up to 14 days]
AUC0-tz of CCX168-M1 [Up to 14 days]
AUC During a Dosing Interval of CCX168 [Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7]
AUC During a Dosing Interval of CCX168-M1 [Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7]
Terminal Elimination Half-life of CCX168 [Up to 14 days]
Terminal Elimination Half-life of CCX168-M1 [Up to 14 days]
Apparent Oral Clearance of CCX168 [Up to 14 days]
Apparent Volume of Distribution During the Terminal Phase of CCX168 [Up to 14 days]
Mean Residence Time to Infinity of CCX168 [Up to 14 days]
Accumulation Ratio of CCX168 [Cohorts B and D only: Up to 14 days]
Accumulation Ratio of CCX168-M1 [Cohorts B and D only: Up to 14 days]
Trough Plasma Concentration at the End of Dosing Interval of CCX168 [Cohorts B and D only: Up to 14 days]
Trough Plasma Concentration at the End of Dosing Interval of CCX168-M1 [Cohorts B and D only: Up to 14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.