Clinical trial NCT06004947: A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications
Official title: An Open-Label, Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
Keywords: Renal diseases
Atypical hemolytic uremic syndrome
Immunoglobulin A nephropathy
Complement 5a receptor (C5aR)
Complement
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-08-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* Participant is known as a CYP2C9 poor metabolizer.

Primary outcomes:
measure: Cohort A: Maximum Plasma Concentration (Cmax) of Midazolam
timeFrame: Up to Day 13
measure: Cohort A: Cmax of Celecoxib
timeFrame: Up to Day 13
measure: Cohort A: Time of Cmax (Tmax) of Midazolam
timeFrame: Up to Day 13
measure: Cohort A: Tmax of Celecoxib
timeFrame: Up to Day 13
measure: Cohort A: Area under the plasma concentration-time curve (AUC) from Time 0 to infinity of Midazolam
timeFrame: Up to Day 13
measure: Cohort A: AUC from Time 0 to infinity of Celecoxib
timeFrame: Up to Day 13
measure: Cohort A: Apparent Terminal Half Life of Midazolam
timeFrame: Up to Day 13
measure: Cohort A: Apparent Terminal Half Life of Celecoxib
timeFrame: Up to Day 13
measure: Cohort A: Cmax of CCX168
timeFrame: Day 15 up to Day 19
measure: Cohort A: Tmax of CCX168
timeFrame: Day 15 up to Day 19
measure: Cohort A: AUC Over the Dosing Interval of CCX168
timeFrame: Day 15 up to Day 19
measure: Cohort B: Cmax of CCX168
timeFrame: Up to Day 14
measure: Cohort B: Tmax of CCX168
timeFrame: Up to Day 14
measure: Cohort B: AUC from Time 0 to infinity of CCX168
timeFrame: Up to Day 14
measure: Cohort B: Apparent Terminal Half Life of CCX168
timeFrame: Up to Day 14
Secondary outcomes:
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to Day 29
measure: Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
timeFrame: Up to Day 19
measure: Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
timeFrame: Up to Day 19
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: