Anti-neutrophil Cytoplasmic Antibody-associated VasculitisPhase 1NCT05988021
A Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168
A Phase 1 study testing CCX168 in people with Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis, run by Amgen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
- What is being tested?
- CCX168
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2015to 25 May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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;
- History or presence of unexplained syncope or family history of sudden death, or any medical condition or disease which, in the opinion of the Investigator, may place the participants 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 dosing;
- Participant's hemoglobin less than 11.5 g/dL for women or less than 13.0 g/dL for men at screening or check-in, confirmed by a repeat measurement;
- Participated in any clinical study of an investigational product within 30 days prior to dosing, or within 5 half-lives after dosing;
- Participant has any evidence of hepatic disease; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or bilirubin greater than 1.5 times the upper limit of normal at screening or check-in;
- Participant's white blood cell count is below the lower limit of normal at screening or check-in, confirmed by a repeat measurement;
- Participant has any evidence of renal impairment; serum creatinine greater than 1.5 times the upper limit of normal at screening or check-in;
- Participant's urine tested positive at screening and/or on check-in for any of the following: opioids, amphetamines and methamphetamines, cannabinoids, benzodiazepines, barbiturates, cocaine, cotinine, ecstasy, methadone, phencyclidine, tri-cyclic antidepressants, or alcohol (Breathalyzer test allowed for alcohol).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Phase 1 Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168
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.
- Being tested
- CCX168
- Keywords
- Vasculitis, Complement, C5aR, Vascular diseases, Cardiovascular diseases, Systemic vasculitis, ANCA
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Vasculitis, Vascular Diseases, Cardiovascular Diseases, Systemic Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCX168Drug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: CCX168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of CCX168
Measured: Up to 35 days
Time of Cmax (Tmax) of CCX168
Measured: Up to 35 days
Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t (AUC0-t)
Measured: Up to 35 days
AUC of CCX168 From Time 0 to Infinity (AUC0-inf)
Measured: Up to 35 days
Secondary outcomes (4)
Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Measured: Up to 35 days
Number of Participants Experiencing Adverse Events (AEs)
Measured: Up to 35 days
Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
Measured: Up to 35 days
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
Measured: Up to 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start3 Dec 2015
- Primary completion9 Feb 2016
- Study completion25 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-neutrophil Cytoplasmic Antibody-associated VasculitisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988021
- Sponsor's protocol ID
- CL007_168
- Status last verified
- Jul 2023
- First submitted
- 4 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 1 Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168
- ClinicalTrials.gov ID
- NCT05988021
- Acronym / sponsor ID
- CL007_168
- Keywords
- Vasculitis, Complement, C5aR, Vascular diseases, Cardiovascular diseases, Systemic vasculitis, ANCA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2015 (actual)
- Primary completion
- 9 Feb 2016 (actual)
- Study completion
- 25 May 2016 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Sequence ABCD | Experimental | Drug: CCX168Participants 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). |
| Cohort 2: Sequence BACD | Experimental | Drug: CCX168Participants 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (23 listed)
- 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:
- History of additional significant risk factors for torsade de pointes, including heart failure, hypokalemia, hypocalcemia, hypomagnesemia, family history of long QT syndrome;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCX168Administered orally. | Drug | Cohort 1: Sequence ABCD, Cohort 2: Sequence BACD |
Primary outcome
Maximum Plasma Concentration (Cmax) of CCX168
Time frame: Up to 35 days
Time of Cmax (Tmax) of CCX168
Time frame: Up to 35 days
Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t (AUC0-t)
Time frame: Up to 35 days
AUC of CCX168 From Time 0 to Infinity (AUC0-inf)
Time frame: Up to 35 days
4 secondary outcomes
Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Up to 35 days
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to 35 days
Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
Time frame: Up to 35 days
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
Time frame: Up to 35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CCX168 in people with Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis, run by Amgen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of CCX168 (time frame: Up to 35 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.