NCT05984251

Brief Summary

The primary objective of this study will be to evaluate the safety and tolerability of single and multiple oral doses of CCX168, over a range of dose levels, in healthy male and female participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2009

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 21, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2011

Completed
12.3 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

August 2, 2023

Last Update Submit

August 2, 2023

Conditions

VasculitisSystemic Lupus Erythematosus (SLE)

Keywords

ComplementC5aRVascular diseasesCardiovascular diseases

Outcome Measures

Primary Outcomes (4)

  • Number of Participants Experiencing Adverse Events (AEs)

    Up to 43 days

  • Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters

    Up to 29 days

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

    Up to 29 days

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

    Up to 29 days

Secondary Outcomes (14)

  • Maximum Plasma Concentration (Cmax) of CCX168

    Period 1: Up to Day 8; Period 2: Up to Day 15

  • Time of Cmax of CCX168

    Period 1: Up to Day 8; Period 2: Up to Day 15

  • Terminal Phase Rate Constant of CCX168

    Period 1: Up to Day 8; Period 2: Up to Day 15

  • Apparent Terminal Half-life of CCX168

    Period 1: Up to Day 8; Period 2: Up to Day 15

  • Apparent Oral Clearance of CCX168

    Period 1: Up to Day 8; Period 2: Up to Day 15

  • +9 more secondary outcomes

Study Arms (5)

Cohort 1

EXPERIMENTAL

During Period 1, participants will receive a single dose of CCX168 1 mg or placebo. During the second study period, participants will receive the same dose as during the first period but once daily (QD) for a period of 7 days continuously.

Drug: CCX168Drug: Placebo

Cohort 2

EXPERIMENTAL

During Period 1, participants will receive a single dose of CCX168 3 mg or placebo. During the second study period, participants will receive the same dose as during the first period but QD for a period of 7 days continuously.

Drug: CCX168Drug: Placebo

Cohort 3

EXPERIMENTAL

During Period 1, participants will receive a single dose of CCX168 10 mg or placebo. During the second study period, participants will receive the same dose as during the first period but QD for a period of 7 days continuously.

Drug: CCX168Drug: Placebo

Cohort 4

EXPERIMENTAL

During Period 1, participants will receive a single dose of CCX168 30 mg or placebo. During the second study period, participants will receive the same dose as during the first period or placebo twice daily (BID) for a period of 7 days continuously.

Drug: CCX168Drug: Placebo

Cohort 5

EXPERIMENTAL

During Period 1, participants will receive a single dose of CCX168 100 mg or placebo. During the second study period, participants will receive the same dose as during the first period or placebo BID for a period of 7 days continuously.

Drug: CCX168Drug: Placebo

Interventions

CCX168DRUG

Administered orally.

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5
PlaceboDRUG

Administered orally.

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female participants, aged 19-45 years inclusive, who are in generally good health, whose body mass index is 19 to 29 kg/m\^2;
  • 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, and
  • Female participants of childbearing potential, and male participants with partners of childbearing potential, may participate if adequate contraception is used during, and for at least the four weeks after, any administration of study medication.

You may not qualify if:

  • Women who are pregnant, breastfeeding, or have a positive serum pregnancy test at Screening and/or on Study Day -1;
  • Expected requirement for use of any medication (with the exception of continuing use by female participants of hormonal contraceptives in accordance with a regimen that has been stable for at least the three months prior to Screening) during the study period;
  • History within the three months prior to study entry of use of tobacco and/or nicotine containing products;
  • History within one year prior to study entry of illicit drug use;
  • History of alcohol abuse at any time in the past;
  • History of any form of cancer;
  • Consumed alcoholic beverages, or any food or drink containing grapefruit or grapefruit juice within 24 hours of screening;
  • History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the participant at unacceptable risk for study participation;
  • Donated or lost more than 350 mL of blood or blood products within 56 days prior to Screening, or donated plasma within 7 days of randomization;
  • Participant's hemoglobin less than 12 g/dL (or less than 7.45 mmol/L);
  • Participated in any clinical study of an investigational product within 30 days prior to randomization;
  • Participant has any evidence of hepatic disease; aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, or bilirubin \> 1.5 x the upper limit of normal;
  • Participant has any evidence of renal impairment; serum creatinine \> 1.5 x upper limit of normal, and
  • Participant's urine tested positive at Screening and/or on Study Day -1 for any of the following: opioids, amphetamines, cannabinoids, benzodiazepines, barbiturates, cocaine, cotinine, or alcohol (Breathalyzer test allowed for alcohol).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit (CRU) AG

Allschwil, CH-4123, Switzerland

Location

Related Links

MeSH Terms

Conditions

VasculitisLupus Erythematosus, SystemicVascular DiseasesCardiovascular Diseases

Interventions

avacopan

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 9, 2023

Study Start

December 21, 2009

Primary Completion

September 19, 2010

Study Completion

April 11, 2011

Last Updated

August 9, 2023

Record last verified: 2023-08

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

CH(1)