A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications

NCT06004947 | Completed Phase 1 FDA Drug

• 1 other identifier: CL008_168
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study will be to evaluate the drug-drug interaction potential of CCX168 with concomitant medications, as either a perpetrator or a victim, following oral administration of CCX168 to healthy participants.

Conditions

Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis

Keywords

Renal diseases; Atypical hemolytic uremic syndrome; Immunoglobulin A nephropathy; Complement 5a receptor (C5aR); Complement

Outcome Measures

Primary Outcomes (15)

• Cohort A: Maximum Plasma Concentration (Cmax) of Midazolam

  Up to Day 13

• Cohort A: Cmax of Celecoxib

  Up to Day 13

• Cohort A: Time of Cmax (Tmax) of Midazolam

  Up to Day 13

• Cohort A: Tmax of Celecoxib

  Up to Day 13

• Cohort A: Area under the plasma concentration-time curve (AUC) from Time 0 to infinity of Midazolam

  Up to Day 13

• Cohort A: AUC from Time 0 to infinity of Celecoxib

  Up to Day 13

• Cohort A: Apparent Terminal Half Life of Midazolam

  Up to Day 13

• Cohort A: Apparent Terminal Half Life of Celecoxib

  Up to Day 13

• Cohort A: Cmax of CCX168

  Day 15 up to Day 19

• Cohort A: Tmax of CCX168

  Day 15 up to Day 19

• Cohort A: AUC Over the Dosing Interval of CCX168

  Day 15 up to Day 19

• Cohort B: Cmax of CCX168

  Up to Day 14

• Cohort B: Tmax of CCX168

  Up to Day 14

• Cohort B: AUC from Time 0 to infinity of CCX168

  Up to Day 14

• Cohort B: Apparent Terminal Half Life of CCX168

  Up to Day 14

Secondary Outcomes (3)

• Number of Participants Experiencing Adverse Events (AEs)

  Up to Day 29

• Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters

  Up to Day 19

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

  Up to Day 19

Study Arms (2)

Cohort A

EXPERIMENTAL

A single dose of 2 mg midazolam (a Cytochrome P450 \[CYP\]3A4 probe drug) and a single dose of 200 mg celecoxib (a CYP2C9 probe drug) will be given orally concurrently on Day 1 and Day 13. On Day 3 through Day 18, CCX168 will be given orally at 30 mg twice daily (b.i.d.), and a single dose of 30 mg CCX168 will be given in the morning on Day 19. On Day 16 through Day 19, a once daily (q.d.) dose of 200 mg itraconazole (a CYP3A4 inhibitor) will be given orally.

Drug: CCX168; Drug: Midazolam; Drug: Celecoxib; Drug: Itraconazole

Cohort B

EXPERIMENTAL

A single dose of 30 mg CCX168 will be given on Day 1 and Day 14, while rifampicin (a CYP3A4 inducer) will be given at 600 mg once daily from Day 4 through Day 17.

Drug: CCX168; Drug: Rifampicin

Interventions

CCX168 DRUG

Administered orally.

Cohort A; Cohort B

Midazolam DRUG

Administered orally.

Cohort A

Celecoxib DRUG

Administered orally.

Cohort A

Itraconazole DRUG

Administered orally.

Cohort A

Rifampicin DRUG

Administered orally.

Cohort B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female participants, aged 18-55 years inclusive, who are in generally good health as judged by the Investigator, 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 electrocardiogram, 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:

• Pregnant or breastfeeding;
• 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; herbal supplements must be stopped 7 days prior to check-in;
• 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; strenuous exercise must be stopped 4 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;
• 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 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 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 check-in for any of the following: opioids, amphetamines and methamphetamines, cannabinoids, benzodiazepines, barbiturates, cocaine, cotinine, methylenedioxymethamphetamine (MDMA or "ecstasy"), methadone, phencyclidine, tri-cyclic antidepressants, or alcohol (Breathalyzer test allowed for alcohol).

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Kidney Diseases; Atypical Hemolytic Uremic Syndrome; Glomerulonephritis, IGA

Interventions

avacopan; Midazolam; Celecoxib; Itraconazole; Rifampin

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemolytic-Uremic Syndrome; Uremia; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Glomerulonephritis; Nephritis

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Triazoles; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 22, 2023
• Study Start: January 14, 2016
• Primary Completion: March 15, 2016
• Study Completion: June 10, 2016
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)