A Phase I Clinical Study of CCX168 in Japanese and Caucasian Healthy Adult Males
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: CCX168 (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: CCX168 (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: CCX168 (Drug)
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.
干预措施: Placebo (Drug)
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.
干预措施: CCX168 (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Experiencing Adverse Events
时间窗: Up to 14 days
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
时间窗: Up to 14 days
Maximum Plasma Concentration (Cmax) of CCX168
时间窗: Up to 14 days
Tmax of CCX168-M1
时间窗: Up to 14 days
Terminal Elimination Half-life of CCX168
时间窗: Up to 14 days
Apparent Volume of Distribution During the Terminal Phase of CCX168
时间窗: Up to 14 days
Number of Participants Experiencing Adverse Drug Reactions
时间窗: Up to 14 days
Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters
时间窗: Up to 14 days
Number of Participants Experiencing Clinically Significant Changes in Clinical Laboratory Parameters
时间窗: Up to 14 days
Cmax of CCX168-M1 (Metabolite)
时间窗: Up to 14 days
Time of Cmax (tmax) of CCX168
时间窗: Up to 14 days
Area Under the Plasma Concentration Time Curve (AUC) from Time 0 to Infinity (AUC0-inf) of CCX168
时间窗: Up to 14 days
AUC During a Dosing Interval of CCX168
时间窗: Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7
AUC During a Dosing Interval of CCX168-M1
时间窗: 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
时间窗: Cohorts B and D only: Up to 14 days
AUC0-inf of CCX168-M1
时间窗: Up to 14 days
AUC from Time 0 to Time of Last Measurable Plasma Concentration (AUC0-tz) of CCX168
时间窗: Up to 14 days
AUC0-tz of CCX168-M1
时间窗: Up to 14 days
Terminal Elimination Half-life of CCX168-M1
时间窗: Up to 14 days
Accumulation Ratio of CCX168-M1
时间窗: Cohorts B and D only: Up to 14 days
Apparent Oral Clearance of CCX168
时间窗: Up to 14 days
Mean Residence Time to Infinity of CCX168
时间窗: Up to 14 days
Accumulation Ratio of CCX168
时间窗: Cohorts B and D only: Up to 14 days
Trough Plasma Concentration at the End of Dosing Interval of CCX168-M1
时间窗: Cohorts B and D only: Up to 14 days
次要结局
未报告次要终点