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Completed

NCT Number: NCT05988008

A Study of CCX168 in Japanese and Caucasian Healthy Adult Males

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.

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Key information

Conditions

Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis Autoimmune Diseases Cardiovascular Diseases Immune System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sumida Hospital, SOUSEIKAI Global Clinical Research Center

Sumida City, Tokyo, 130-0004, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CCX168

Drug

Administered orally.

Other names: Avacopan

Placebo

Drug

Administered orally.

Primary outcomes

  1. Number of Participants Experiencing Adverse Events

    Time frame: Up to 14 days

  2. Number of Participants Experiencing Adverse Drug Reactions

    Time frame: Up to 14 days

  3. Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters

    Time frame: Up to 14 days

  4. Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters

    Time frame: Up to 14 days

  5. Number of Participants Experiencing Clinically Significant Changes in Clinical Laboratory Parameters

    Time frame: Up to 14 days

  6. Maximum Plasma Concentration (Cmax) of CCX168

    Time frame: Up to 14 days

  7. Cmax of CCX168-M1 (Metabolite)

    Time frame: Up to 14 days

  8. Time of Cmax (tmax) of CCX168

    Time frame: Up to 14 days

  9. Tmax of CCX168-M1

    Time frame: Up to 14 days

  10. Area Under the Plasma Concentration Time Curve (AUC) from Time 0 to Infinity (AUC0-inf) of CCX168

    Time frame: Up to 14 days

  11. AUC0-inf of CCX168-M1

    Time frame: Up to 14 days

  12. AUC from Time 0 to Time of Last Measurable Plasma Concentration (AUC0-tz) of CCX168

    Time frame: Up to 14 days

  13. AUC0-tz of CCX168-M1

    Time frame: Up to 14 days

  14. AUC During a Dosing Interval of CCX168

    Time frame: Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7

  15. AUC During a Dosing Interval of CCX168-M1

    Time frame: Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7

  16. Terminal Elimination Half-life of CCX168

    Time frame: Up to 14 days

  17. Terminal Elimination Half-life of CCX168-M1

    Time frame: Up to 14 days

  18. Apparent Oral Clearance of CCX168

    Time frame: Up to 14 days

  19. Apparent Volume of Distribution During the Terminal Phase of CCX168

    Time frame: Up to 14 days

  20. Mean Residence Time to Infinity of CCX168

    Time frame: Up to 14 days

  21. Accumulation Ratio of CCX168

    Time frame: Cohorts B and D only: Up to 14 days

  22. Accumulation Ratio of CCX168-M1

    Time frame: Cohorts B and D only: Up to 14 days

  23. Trough Plasma Concentration at the End of Dosing Interval of CCX168

    Time frame: Cohorts B and D only: Up to 14 days

  24. Trough Plasma Concentration at the End of Dosing Interval of CCX168-M1

    Time frame: Cohorts B and D only: Up to 14 days

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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