NCT05988021

Brief Summary

The primary objective of this clinical trial is to evaluate the effect of a high-fat, high-calorie meal on the pharmacokinetic (PK) profile of CCX168, following oral administration of a single dose of 30 mg CCX168 to healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2016

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 14, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

August 4, 2023

Last Update Submit

August 4, 2023

Conditions

Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis

Keywords

VasculitisComplementC5aRVascular diseasesCardiovascular diseasesSystemic vasculitisANCA

Outcome Measures

Primary Outcomes (4)

  • Maximum Plasma Concentration (Cmax) of CCX168

    Up to 35 days

  • Time of Cmax (Tmax) of CCX168

    Up to 35 days

  • Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t (AUC0-t)

    Up to 35 days

  • AUC of CCX168 From Time 0 to Infinity (AUC0-inf)

    Up to 35 days

Secondary Outcomes (4)

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

    Up to 35 days

  • Number of Participants Experiencing Adverse Events (AEs)

    Up to 35 days

  • Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters

    Up to 35 days

  • Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters

    Up to 35 days

Study Arms (2)

Cohort 1: Sequence ABCD

EXPERIMENTAL

Participants assigned to sequence ABCD will receive the following treatments: Period 1: Single dose of 30 mg CCX168 after a high-fat, high-calorie meal (Treatment A). Period 2: After a washout period of ≥ 10 days, single dose of 30 mg CCX168 in the fasted state (Treatment B). Period 3: After a washout period of ≥ 10 days, single dose of 3 mg CCX168 in the fasted state (Treatment C). Period 4: 24 hours after the 3 mg CCX168 dose in Period 3, single dose of 100 mg CCX168 on Day 1, and then 100 mg CCX168 twice daily from Day 2 through Day 6. On Day 7, only a morning dose of 100 mg CCX168 (Treatment D).

Drug: CCX168

Cohort 2: Sequence BACD

EXPERIMENTAL

Participants assigned to sequence BACD will receive the following treatments: Period 1: Single dose of 30 mg CCX168 in the fasted state (Treatment B). Period 2: After a washout period of ≥ 10 days, single dose of 30 mg CCX168 after a high-fat, high-calorie meal (Treatment A). Period 3: After a washout period of ≥ 10 days, single dose of 3 mg CCX168 in the fasted state (Treatment C). Period 4: 24 hours after the 3 mg CCX168 dose in Period 3, single dose of 100 mg CCX168 on Day 1, and then 100 mg CCX168 twice daily from Day 2 through Day 6. On Day 7, only a morning dose of 100 mg CCX168 (Treatment D).

Drug: CCX168

Interventions

CCX168DRUG

Administered orally.

Cohort 1: Sequence ABCDCohort 2: Sequence BACD

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female participants, aged 18-55 years inclusive, who are in generally good health, whose body mass index is 19.0 to 32.0 kg/m\^2 inclusive;
  • Willing and able to give written Informed Consent and to comply with the requirements of the study protocol;
  • Negative result of the human immunodeficiency virus screen, the hepatitis B screen, and the hepatitis C screen;
  • Judged to be healthy by the Investigator, based on medical history, physical examination (including ECG, and clinical laboratory assessments. Participants with clinical laboratory values that are outside of normal limits and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance may be entered into the study;
  • Female participants of childbearing potential, or male participants with partners of childbearing potential may participate if adequate contraception is used during, and for at least 90 days after, any administration of study medication.

You may not qualify if:

  • Women who are pregnant, lactating, or have a positive serum pregnancy test at screening or check-in (Day -2);
  • Myocardial infarction or active ischemic heart disease within 12 months before screening;
  • Significant abnormal ECG: Pacemaker, any conduction abnormality associated with a QRS ≥120 msec, poorly-defined or abnormal T wave morphology precluding end of T measurement, abnormal rhythm for age, evidence of previous myocardial infarction (Q waves, S-T segment changes), sinus pauses \> 2.5 seconds, ventricular couplets, triplets or other arrhythmia, symptomatic or asymptomatic;
  • Has any of the following abnormalities:
  • Heart rate \<40 or \>100 bpm
  • PR interval \<110 or ≥220 msec
  • QRS duration ≥120 msec
  • QTcF interval \<350 or \>450 msec;
  • History of additional significant risk factors for torsade de pointes, including heart failure, hypokalemia, hypocalcemia, hypomagnesemia, family history of long QT syndrome;
  • Used a prescription and/or over-the-counter medication, with the exception of ibuprofen, hormonal contraceptives, and multi-vitamins, within 14 days prior to check-in;
  • History within the three months prior to check-in of use of tobacco and/or nicotine-containing products;
  • History within one year prior to check-in of illicit drug use;
  • History of alcohol abuse at any time in the past;
  • Has a history or presence of any form of cancer within the 5 years prior to check-in, with the exception of excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis;
  • For at least 14 days prior to check-in and throughout the blood sample collection period, participants will not be allowed to eat any food or drink any beverage containing alcohol, grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard greens) and charbroiled meats;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Related Links

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisVasculitisVascular DiseasesCardiovascular DiseasesSystemic Vasculitis

Interventions

avacopan

Condition Hierarchy (Ancestors)

Skin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

December 3, 2015

Primary Completion

February 9, 2016

Study Completion

May 25, 2016

Last Updated

August 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
More information

Locations

US(1)