Anti-neutrophil Cytoplasmic Antibody-associated VasculitisPhase 1NCT05988008
A Study of CCX168 in Japanese and Caucasian Healthy Adult Males
A Phase 1 study testing CCX168 in people with Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis, run by Amgen at 1 site in Japan.
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… Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy 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?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- 23 Oct 2017to 20 Sep 2018
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Sumida Hospital, SOUSEIKAI Global Clinical Research Center
Sumida City, Tokyo, 130-0004
About this study
Official title: A Phase I Clinical 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.
- Being tested
- CCX168, Placebo
- Keywords
- Human C5a receptor (C5aR), Vasculitis, Complement, Vascular disease
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Vasculitis, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCX168Drug
Also called Avacopan
Administered orally.
PlaceboDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Single Oral Dosing of CCX168 in Japanese Adult Males | Experimental | Healthy Japanese adult males will receive 1 of 3 single oral doses of CCX168 (10 mg, 30 mg or 100 mg) or placebo. Each dose level will be administered under fasted conditions. Single doses of CCX168 30 mg will be administered under fasted and fed conditions. Receives: Drug: CCX168; Drug: Placebo |
| Cohort B: Multiple Oral Dosing of CCX168 in Japanese Adult Males | Experimental | Healthy Japanese adult males will receive 1 of 2 oral doses of CCX168 (30 mg or 50 mg) or placebo twice-daily for 7 days under fed conditions. Receives: Drug: CCX168; Drug: Placebo |
| Cohort C: Single Oral Dosing of CCX168 in Caucasian Adult Males | Experimental | Healthy Caucasian adult males will receive 1 of 2 single oral doses of CCX168 (10 mg or 30 mg) or placebo under fasted conditions. Receives: Drug: CCX168; Drug: Placebo |
| Cohort D: Multiple Oral Dosing of CCX168 in Caucasian Adult Males | Experimental | Healthy Caucasian adult males will receive an oral dose of CCX168 30 mg or placebo twice-daily for 7 days under fed conditions. Receives: Drug: CCX168; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events
Measured: Up to 14 days
Number of Participants Experiencing Adverse Drug Reactions
Measured: Up to 14 days
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
Measured: Up to 14 days
Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Measured: Up to 14 days
Number of Participants Experiencing Clinically Significant Changes in Clinical Laboratory Parameters
Measured: Up to 14 days
Maximum Plasma Concentration (Cmax) of CCX168
Measured: Up to 14 days
Cmax of CCX168-M1 (Metabolite)
Measured: Up to 14 days
Time of Cmax (tmax) of CCX168
Measured: Up to 14 days
Tmax of CCX168-M1
Measured: Up to 14 days
Area Under the Plasma Concentration Time Curve (AUC) from Time 0 to Infinity (AUC0-inf) of CCX168
Measured: Up to 14 days
AUC0-inf of CCX168-M1
Measured: Up to 14 days
AUC from Time 0 to Time of Last Measurable Plasma Concentration (AUC0-tz) of CCX168
Measured: Up to 14 days
AUC0-tz of CCX168-M1
Measured: Up to 14 days
AUC During a Dosing Interval of CCX168
Measured: Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7
AUC During a Dosing Interval of CCX168-M1
Measured: Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7
Terminal Elimination Half-life of CCX168
Measured: Up to 14 days
Terminal Elimination Half-life of CCX168-M1
Measured: Up to 14 days
Apparent Oral Clearance of CCX168
Measured: Up to 14 days
Apparent Volume of Distribution During the Terminal Phase of CCX168
Measured: Up to 14 days
Mean Residence Time to Infinity of CCX168
Measured: Up to 14 days
Accumulation Ratio of CCX168
Measured: Cohorts B and D only: Up to 14 days
Accumulation Ratio of CCX168-M1
Measured: Cohorts B and D only: Up to 14 days
Trough Plasma Concentration at the End of Dosing Interval of CCX168
Measured: Cohorts B and D only: Up to 14 days
Trough Plasma Concentration at the End of Dosing Interval of CCX168-M1
Measured: Cohorts B and D only: Up to 14 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 start23 Oct 2017
- Primary completion26 Jan 2018
- Study completion20 Sep 2018
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 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
- NCT05988008
- Sponsor's protocol ID
- CCX1101
- Status last verified
- Jul 2023
- First submitted
- 4 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- 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
- A Phase I Clinical Study of CCX168 in Japanese and Caucasian Healthy Adult Males
- ClinicalTrials.gov ID
- NCT05988008
- Acronym / sponsor ID
- CCX1101
- Keywords
- Human C5a receptor (C5aR), Vasculitis, Complement, Vascular disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 20 Sep 2018 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Single Oral Dosing of CCX168 in Japanese Adult Males | Experimental | Drug: CCX168, Drug: PlaceboHealthy Japanese adult males will receive 1 of 3 single oral doses of CCX168 (10 mg, 30 mg or 100 mg) or placebo. Each dose level will be administered under fasted conditions. Single doses of CCX168 30 mg will be administered under fasted and fed conditions. |
| Cohort B: Multiple Oral Dosing of CCX168 in Japanese Adult Males | Experimental | Drug: CCX168, Drug: PlaceboHealthy Japanese adult males will receive 1 of 2 oral doses of CCX168 (30 mg or 50 mg) or placebo twice-daily for 7 days under fed conditions. |
| Cohort C: Single Oral Dosing of CCX168 in Caucasian Adult Males | Experimental | Drug: CCX168, Drug: PlaceboHealthy Caucasian adult males will receive 1 of 2 single oral doses of CCX168 (10 mg or 30 mg) or placebo under fasted conditions. |
| Cohort D: Multiple Oral Dosing of CCX168 in Caucasian Adult Males | Experimental | Drug: CCX168, Drug: PlaceboHealthy Caucasian adult males will receive an oral dose of CCX168 30 mg or placebo twice-daily for 7 days under fed conditions. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (15 listed)
- 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;
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 |
|---|---|---|
| CCX168Also: AvacopanAdministered orally. | Drug | Cohort A: Single Oral Dosing of CCX168 in Japanese Adult Males, Cohort B: Multiple Oral Dosing of CCX168 in Japanese Adult Males, Cohort C: Single Oral Dosing of CCX168 in Caucasian Adult Males, Cohort D: Multiple Oral Dosing of CCX168 in Caucasian Adult Males |
| PlaceboAdministered orally. | Drug | Cohort A: Single Oral Dosing of CCX168 in Japanese Adult Males, Cohort B: Multiple Oral Dosing of CCX168 in Japanese Adult Males, Cohort C: Single Oral Dosing of CCX168 in Caucasian Adult Males, Cohort D: Multiple Oral Dosing of CCX168 in Caucasian Adult Males |
Primary outcome
Number of Participants Experiencing Adverse Events
Time frame: Up to 14 days
Number of Participants Experiencing Adverse Drug Reactions
Time frame: Up to 14 days
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
Time frame: Up to 14 days
Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Up to 14 days
Number of Participants Experiencing Clinically Significant Changes in Clinical Laboratory Parameters
Time frame: Up to 14 days
Maximum Plasma Concentration (Cmax) of CCX168
Time frame: Up to 14 days
Cmax of CCX168-M1 (Metabolite)
Time frame: Up to 14 days
Time of Cmax (tmax) of CCX168
Time frame: Up to 14 days
Tmax of CCX168-M1
Time frame: Up to 14 days
Area Under the Plasma Concentration Time Curve (AUC) from Time 0 to Infinity (AUC0-inf) of CCX168
Time frame: Up to 14 days
AUC0-inf of CCX168-M1
Time frame: Up to 14 days
AUC from Time 0 to Time of Last Measurable Plasma Concentration (AUC0-tz) of CCX168
Time frame: Up to 14 days
AUC0-tz of CCX168-M1
Time frame: Up to 14 days
AUC During a Dosing Interval of CCX168
Time frame: Cohorts B and D only: Up to Hour 12 post-dose on Days 1 - 7
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
Terminal Elimination Half-life of CCX168
Time frame: Up to 14 days
Terminal Elimination Half-life of CCX168-M1
Time frame: Up to 14 days
Apparent Oral Clearance of CCX168
Time frame: Up to 14 days
Apparent Volume of Distribution During the Terminal Phase of CCX168
Time frame: Up to 14 days
Mean Residence Time to Infinity of CCX168
Time frame: Up to 14 days
Accumulation Ratio of CCX168
Time frame: Cohorts B and D only: Up to 14 days
Accumulation Ratio of CCX168-M1
Time frame: Cohorts B and D only: Up to 14 days
Trough Plasma Concentration at the End of Dosing Interval of CCX168
Time frame: Cohorts B and D only: Up to 14 days
Trough Plasma Concentration at the End of Dosing Interval of CCX168-M1
Time frame: Cohorts B and D only: Up to 14 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 Japan.
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 3 inclusion and 15 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 Japan. 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?
Number of Participants Experiencing Adverse Events (time frame: Up to 14 days). The study lists 24 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.