VasculitisPhase 1NCT05984251

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants

A Phase 1 study testing CCX168 in people with Vasculitis and Systemic Lupus Erythematosus (SLE), run by Amgen at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Vasculitis, Systemic Lupus Erythematosus (SLE)
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: 48 participants
Where: 1 siteSwitzerland
Study dates: 21 Dec 2009to 11 Apr 2011
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 19 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 14Show fewer

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).

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Covance Clinical Research Unit (CRU) AG
Allschwil, CH-4123

Other trials in Switzerland

About this study

Official title: A Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Male and Female Subjects

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.

Conditions: Vasculitis, Systemic Lupus Erythematosus (SLE)
Being tested: CCX168, Placebo
Keywords: Complement, C5aR, Vascular diseases, Cardiovascular diseases
Medical subject headings: Vasculitis, Lupus Erythematosus, Systemic, Vascular Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CCX168Drug
Administered orally.
PlaceboDrug
Administered orally.

Study groups in NCT05984251
Study group	Role	What they receive
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. Receives: Drug: CCX168; Drug: 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. Receives: Drug: CCX168; Drug: 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. Receives: Drug: CCX168; Drug: 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. Receives: Drug: CCX168; Drug: 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. 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 (AEs)
Measured: Up to 43 days
Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
Measured: Up to 29 days
Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Measured: Up to 29 days
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
Measured: Up to 29 days

Secondary outcomes (14)

Maximum Plasma Concentration (Cmax) of CCX168
Measured: Period 1: Up to Day 8; Period 2: Up to Day 15
Time of Cmax of CCX168
Measured: Period 1: Up to Day 8; Period 2: Up to Day 15
Terminal Phase Rate Constant of CCX168
Measured: Period 1: Up to Day 8; Period 2: Up to Day 15
Apparent Terminal Half-life of CCX168
Measured: Period 1: Up to Day 8; Period 2: Up to Day 15
Apparent Oral Clearance of CCX168
Measured: Period 1: Up to Day 8; Period 2: Up to Day 15
Apparent Volume of Distribution of CCX168
Measured: Period 1: Up to Day 8; Period 2: Up to Day 15
Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t
Measured: Period 1: Up to Day 8; Period 2: Up to Day 15
AUC of CCX168 From Time 0 to Infinity
Measured: Period 1: Up to Day 8; Period 2: Up to Day 15
AUC of CCX168 From Time 0 to 24 Hours
Measured: Periods 1 and 2: Up to Hour 24
AUC of CCX168 From Time 0 to 12 Hours
Measured: Periods 1 and 2: Up to Hour 12
AUC of CCX168 From Time 12 to 24 Hours
Measured: Periods 1 and 2: Hour 12 to Hour 24
Period 2: AUC of CCX168 From Time 0 to the end of the Dosing Interval
Measured: Cohorts 1-3: Up to Hour 24; Cohorts 4-5: Up to Hour 12
Period 2: Accumulation Ratio of CCX168
Measured: Up to Day 7
Percent Inhibition of complement 5a receptor (C5aR)-dependent Upregulation of CD11b in Peripheral Blood Neutrophils
Measured: Period 1: Up to Hour 24; Period 2: Up to 12 hours after the first dose on Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 200911 Apr 2011

First posted9 Aug 2023
Study start21 Dec 2009
Primary completion19 Sep 2010
Study completion11 Apr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05984251
Sponsor's protocol ID: CL001_168
Status last verified: Aug 2023
First submitted: 2 Aug 2023
Last updated: 9 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vasculitis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Male and Female Subjects
ClinicalTrials.gov ID: NCT05984251
Acronym / sponsor ID: CL001_168
Conditions: Vasculitis, Systemic Lupus Erythematosus (SLE)
Keywords: Complement, C5aR, Vascular diseases, Cardiovascular diseases
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 21 Dec 2009 (actual)
Primary completion: 19 Sep 2010 (actual)
Study completion: 11 Apr 2011 (actual)
First posted: 9 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 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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Cohort 1	Experimental	Drug: CCX168, Drug: PlaceboDuring 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.
Cohort 2	Experimental	Drug: CCX168, Drug: PlaceboDuring 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.
Cohort 3	Experimental	Drug: CCX168, Drug: PlaceboDuring 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.
Cohort 4	Experimental	Drug: CCX168, Drug: PlaceboDuring 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.
Cohort 5	Experimental	Drug: CCX168, Drug: PlaceboDuring 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.

Who may qualify

Ages: 19 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (14 listed)

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;

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, Cohort 2, Cohort 3, Cohort 4, Cohort 5
PlaceboAdministered orally.	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5

Primary outcome

Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to 43 days
Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
Time frame: Up to 29 days
Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Up to 29 days
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
Time frame: Up to 29 days

14 secondary outcomes

Maximum Plasma Concentration (Cmax) of CCX168
Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
Time of Cmax of CCX168
Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
Terminal Phase Rate Constant of CCX168
Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
Apparent Terminal Half-life of CCX168
Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
Apparent Oral Clearance of CCX168
Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
Apparent Volume of Distribution of CCX168
Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t
Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
AUC of CCX168 From Time 0 to Infinity
Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
AUC of CCX168 From Time 0 to 24 Hours
Time frame: Periods 1 and 2: Up to Hour 24
AUC of CCX168 From Time 0 to 12 Hours
Time frame: Periods 1 and 2: Up to Hour 12
AUC of CCX168 From Time 12 to 24 Hours
Time frame: Periods 1 and 2: Hour 12 to Hour 24
Period 2: AUC of CCX168 From Time 0 to the end of the Dosing Interval
Time frame: Cohorts 1-3: Up to Hour 24; Cohorts 4-5: Up to Hour 12
Period 2: Accumulation Ratio of CCX168
Time frame: Up to Day 7
Percent Inhibition of complement 5a receptor (C5aR)-dependent Upregulation of CD11b in Peripheral Blood Neutrophils
Time frame: Period 1: Up to Hour 24; Period 2: Up to 12 hours after the first dose on Day 7

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 9 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 Vasculitis and Systemic Lupus Erythematosus (SLE), run by Amgen at 1 site in Switzerland.

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 14 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 9 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 Switzerland. 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 (AEs) (time frame: Up to 43 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?

On the ClinicalTrials.gov record for NCT05984251.

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 9 Aug 2023.