A Study of CCX168 in Japanese and Caucasian Healthy Adult Males

Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05988008
• Other study ID #: CCX1101
• Status: Completed
• Phase: Phase 1
• Start date: October 23, 2017
• Est. completion date: September 20, 2018

Study information

• Verified date: July 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 20, 2018
• Est. primary completion date: January 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
• Vasculitis

Intervention

Drug:
• CCX168
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
Japan	Sumida Hospital, SOUSEIKAI Global Clinical Research Center	Sumida City	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

Japan, 

Outcome

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

External Links

•   AmgenTrials clinical trials website