| Eligibility |
Inclusion Criteria:
1. Male or female adults, 18-55 years of age, inclusive.
2. Body mass index (BMI) is 18.5 to 29.9 kg/m^2.
3. Negative result of the human immunodeficiency virus (HIV) screen, the hepatitis B
screen, the hepatitis C screen, and the QuantiFERON®-TB Gold test.
4. A female participant is eligible to participate if she is of:
1. Non-childbearing potential defined as pre-menopausal females with a documented
bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy
(removal of the ovaries) or hysterectomy; hysteroscopic sterilization, or
post-menopausal defined as =12 months of spontaneous amenorrhea (in questionable
cases a blood sample with simultaneous follicle stimulating hormone [FSH] in the
post-menopausal range is confirmatory). Documented verbal history from the
participant is acceptable for all of the criteria stipulated above.
2. Child-bearing potential and agrees to use effective contraception methods from
the signing of informed consent until 120 days after the last dose of study
treatment.
3. Lactating but willing to stop breast feeding prior to the first dose of study
treatment until 120 days after the last dose of study treatment.
5. Female participants must agree not to donate ova starting at Screening and for 120
days after the final study drug administration.
6. Male participants must agree to use highly effective contraception methods. This
criterion must be followed from the time of the first dose of study treatment until
120 days after the last dose of study treatment.
7. Male participants must agree not to donate sperm starting from the time of the first
dose of study treatment and for 120 days after the final study drug administration
8. Judged by the Investigator to be otherwise fit for the study, based on medical
history, physical examination, and clinical laboratory assessments. Participants with
clinical laboratory values that are outside of normal limits (other than those
specified in the Exclusion Criteria) and/or with other abnormal clinical findings that
are judged by the Investigator not to compromise participant participation in the
study, may be entered into the study
9. Willing and able to provide written Informed Consent and to comply with the
requirements of the study protocol.
Exclusion Criteria:
1. Women who are pregnant, breastfeeding, or have a positive serum pregnancy test at
Screening or on Study Day -1 or women who desire to begin a family or breastfeed
during the full length of the study.
2. Expected requirement for use of any medication (with the exception of continued 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 and post-menopausal
females using estrogen replacement therapy) from Screening through the end of the
study.
3. History within the 60 days prior to the first administration of Investigational
Product (IP) of use of cannabis, tobacco and/or nicotine-containing products.
4. History of drug abuse (either illicit or prescription) within two years prior to first
administration of IP.
5. History of alcohol abuse at any time in the past five years from Screening.
6. History or presence of any form of cancer within the 5 years prior to screening, with
the exception of excised basal cell carcinoma or squamous cell carcinoma of the skin,
or carcinoma in situ such as cervical or breast carcinoma in situ that has been
excised or resected completely and is without evidence of local recurrence or
metastasis.
7. History or presence of any medical condition or disease or laboratory abnormality
which, in the opinion of the Investigator, may place the participant at unacceptable
risk for study participation.
8. Donated or lost more than 50 mL of blood or blood products within 56 days prior to
screening, or donated plasma within 7 days of randomization.
9. Hemoglobin less than the lower limit of normal or recent history (6 months prior to
first dose) of iron deficient anemia.
10. Received a live vaccine or a vaccine for coronavirus 19 disease (COVID-19) within 4
weeks prior to Screening
11. Current or recent COVID-19 infection defined as:
1. positive result of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-V2)
test at screening or Day-1, or
2. symptomatic COVID-19 infection within 30 days prior to Day-1, or
3. continuing COVID-19 long haul symptomatology regardless of when the initial
COVID-19 infection occurred
12. Known hypersensitivity to avacopan or inactive ingredients of the avacopan capsules
(including gelatin, polyethylene glycol, or Cremophor).
13. Participated in any clinical study of an Investigational Product within 30 days or of
5 half-lives prior to randomization.
14. Participant has any evidence of hepatic disease; aspartate aminotransaminase (AST),
alanine aminotransaminase (ALT), alkaline phosphatase, or bilirubin > the upper limit
of normal during screening and Day -1.
15. Participant has any evidence of renal impairment, defined as estimated glomerular
filtration rate (eGFR) <90 mL/min/1.73 m^2 during screening or Day-1
16. Participant's urine tested positive at Screening and/or on Study Day -1 for any of the
following: opioids, opiates, amphetamines, cannabinoids, benzodiazepines,
barbiturates, cocaine, cotinine, or alcohol (Breathalyzer test allowed for alcohol).
17. Use of alcohol-, caffeine-, or xanthine-containing products within 1 week prior to Day
-1.
18. Participant has any evidence of gastro-intestinal disease by exam or history (not
including appendectomy or hernia) which could interfere with oral absorption,
digestion, or uptake. Participants with cholecystectomy should be excluded.
19. Use of any prescription medications (with the exception of hormonal contraceptives and
hormonal therapy), over-the-counter nonsteroidal anti-inflammatory drugs, herbal
preparations, St. John's Wort or consumption of grapefruit juice, grapefruit, or
Seville oranges within 14 days before Day 1 (first dose).
20. Use of over-the-counter medications, vitamins, or supplements (including omega-3 fish
oils) within 7 days before Day 1 (first dose)
21. Participants taking strong cytochrome P450 (CYP)3A4 inducers (e.g., phenytoin,
fosphenytoin, rifampin, carbamazepine, St. John's Wort, nevirapine, pentobarbital,
primidone, rifapentine, enzalutamide, lumacaftor, mitotane, apalutamide, quinine,
rimexolone, rifaximin, rifamycin, topiramate, oxcarbazepine) or moderate CYP3A4
inducers (e.g., bosentan, efavirenz, etravirine, modafinil, dexamethasone, etravirine,
nafcillin, dabrafenib, methotrexate, bexarotene, mifepristone) within 2 weeks prior to
Day 1.
22. Participants taking strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin,
conivaptan, grapefruit juice or grapefruit, Seville oranges, indinavir, itraconazole,
ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole,
ritonavir, saquinavir, telaprevir, telithromycin and voriconazole) within 2 weeks
prior to Day 1.
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