Healthy Volunteers
Conditions
Keywords
Avacopan, CCX168, Simvastatin
Brief summary
The primary objective of this clinical study is to evaluate the effect of repeated oral doses of avacopan (30 mg and 60 mg twice daily approximately 12 hours apart \[BID\]) given under fed conditions on the PK of a single dose of simvastatin (40 mg) in healthy volunteers.
Interventions
DRUGAvacopan
Orally via capsules
DRUGSimvastatin
Orally via tablets
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCinf of β-hydroxy-simvastatin Acid | Up to Day 12 |
| Maximum Observed Plasma Concentration (Cmax) of Simvastatin | Up to Day 12 |
| Cmax of β-hydroxy-simvastatin Acid | Up to Day 12 |
| Area Under the Plasma Concentration-time Curve from Time 0 to the Time Point of Last Quantifiable Plasma Concentration (AUClast) of Simvastatin | Up to Day 12 |
| AUClast of β-hydroxy-simvastatin Acid | Up to Day 12 |
| Area Under the Plasma Concentration-time Curve from Time 0 to Infinity (AUCinf) of Simvastatin | Up to Day 12 |
Secondary
| Measure | Time frame |
|---|---|
| Cmax of Avacopan | Up to Day 12 |
| Cmax of Avacopan Metabolite M1 | Up to Day 12 |
| Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCtau) of Avacopan | Up to Day 12 |
| AUCtau of Avacopan Metabolite M1 | Up to Day 12 |
| Number of Participants Experiencing Adverse Events | Up to Day 26 |
Countries
United States
Outcome results
None listed