A Study of CCX168 in Japanese and Caucasian Healthy Adult Males
Phase 1
Completed
- Conditions
- Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT05988008
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 80
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A: Single Oral Dosing of CCX168 in Japanese Adult Males CCX168 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. Cohort B: Multiple Oral Dosing of CCX168 in Japanese Adult Males Placebo 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. Cohort D: Multiple Oral Dosing of CCX168 in Caucasian Adult Males CCX168 Healthy Caucasian adult males will receive an oral dose of CCX168 30 mg or placebo twice-daily for 7 days under fed conditions. Cohort A: Single Oral Dosing of CCX168 in Japanese Adult Males Placebo 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. Cohort C: Single Oral Dosing of CCX168 in Caucasian Adult Males Placebo Healthy Caucasian adult males will receive 1 of 2 single oral doses of CCX168 (10 mg or 30 mg) or placebo under fasted conditions. Cohort D: Multiple Oral Dosing of CCX168 in Caucasian Adult Males Placebo Healthy Caucasian adult males will receive an oral dose of CCX168 30 mg or placebo twice-daily for 7 days under fed conditions. Cohort B: Multiple Oral Dosing of CCX168 in Japanese Adult Males CCX168 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. Cohort C: Single Oral Dosing of CCX168 in Caucasian Adult Males CCX168 Healthy Caucasian adult males will receive 1 of 2 single oral doses of CCX168 (10 mg or 30 mg) or placebo under fasted conditions.
- Primary Outcome Measures
Name Time Method 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 Apparent Oral Clearance of CCX168 Up to 14 days Number of Participants Experiencing Adverse Events Up to 14 days Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters Up to 14 days Maximum Plasma Concentration (Cmax) of CCX168 Up to 14 days Tmax of CCX168-M1 Up to 14 days Terminal Elimination Half-life of CCX168 Up to 14 days Apparent Volume of Distribution During the Terminal Phase of CCX168 Up to 14 days Number of Participants Experiencing Adverse Drug Reactions 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 Cmax of CCX168-M1 (Metabolite) Up to 14 days Time of Cmax (tmax) of CCX168 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 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 Trough Plasma Concentration at the End of Dosing Interval of CCX168 Cohorts B and D only: Up to 14 days AUC0-tz of CCX168-M1 Up to 14 days Terminal Elimination Half-life of CCX168-M1 Up to 14 days Accumulation Ratio of CCX168-M1 Cohorts B and D only: 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 Trough Plasma Concentration at the End of Dosing Interval of CCX168-M1 Cohorts B and D only: Up to 14 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sumida Hospital, SOUSEIKAI Global Clinical Research Center
🇯🇵Sumida City, Tokyo, Japan