Clinical trial NCT05988008: A Study of CCX168 in Japanese and Caucasian Healthy Adult Males
Official title: A Phase I Clinical Study of CCX168 in Japanese and Caucasian Healthy Adult Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
Keywords: Human C5a receptor (C5aR)
Vasculitis
Complement
Vascular disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 80
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to 14 days
measure: Number of Participants Experiencing Adverse Drug Reactions
timeFrame: Up to 14 days
measure: Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
timeFrame: Up to 14 days
measure: Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters
timeFrame: Up to 14 days
measure: Number of Participants Experiencing Clinically Significant Changes in Clinical Laboratory Parameters
timeFrame: Up to 14 days
measure: Maximum Plasma Concentration (Cmax) of CCX168
timeFrame: Up to 14 days
measure: Cmax of CCX168-M1 (Metabolite)
timeFrame: Up to 14 days
measure: Time of Cmax (tmax) of CCX168
timeFrame: Up to 14 days
measure: Tmax of CCX168-M1
timeFrame: Up to 14 days
measure: Area Under the Plasma Concentration Time Curve (AUC) from Time 0 to Infinity (AUC0-inf) of CCX168
timeFrame: Up to 14 days
measure: AUC0-inf of CCX168-M1
timeFrame: Up to 14 days
measure: AUC from Time 0 to Time of Last Measurable Plasma Concentration (AUC0-tz) of CCX168
timeFrame: Up to 14 days
measure: AUC0-tz of CCX168-M1
timeFrame: Up to 14 days
measure: AUC During a Dosing Interval of CCX168
timeFrame: Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7
measure: AUC During a Dosing Interval of CCX168-M1
timeFrame: Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7
measure: Terminal Elimination Half-life of CCX168
timeFrame: Up to 14 days
measure: Terminal Elimination Half-life of CCX168-M1
timeFrame: Up to 14 days
measure: Apparent Oral Clearance of CCX168
timeFrame: Up to 14 days
measure: Apparent Volume of Distribution During the Terminal Phase of CCX168
timeFrame: Up to 14 days
measure: Mean Residence Time to Infinity of CCX168
timeFrame: Up to 14 days
measure: Accumulation Ratio of CCX168
timeFrame: Cohorts B and D only: Up to 14 days
measure: Accumulation Ratio of CCX168-M1
timeFrame: Cohorts B and D only: Up to 14 days
measure: Trough Plasma Concentration at the End of Dosing Interval of CCX168
timeFrame: Cohorts B and D only: Up to 14 days
measure: Trough Plasma Concentration at the End of Dosing Interval of CCX168-M1
timeFrame: Cohorts B and D only: Up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sumida City
country: Japan
facility: Sumida Hospital, SOUSEIKAI Global Clinical Research Center
state: Tokyo
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: