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Healthy VolunteersPhase 1NCT06207682

Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics (PK) of a Single Dose of Simvastatin

A Phase 1 study testing Avacopan and Simvastatin in people with Healthy Volunteers, run by Amgen at 1 site in United States.

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 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Avacopan and Simvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
28 Jun 2022to 11 Aug 2022
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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female adults, 18-55 years of age, inclusive.
  • Body mass index (BMI) is 18.5 to 29.9 kg/m^2.
  • Negative result of the human immunodeficiency virus (HIV) screen, the hepatitis B screen, the hepatitis C screen, and the QuantiFERON®-TB Gold test.
  • A female participant is eligible to participate if she is of:
  • 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.
  • 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.
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  • 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.
  • Female participants must agree not to donate ova starting at Screening and for 120 days after the final study drug administration.
  • 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.
  • 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
  • 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
  • Willing and able to provide written Informed Consent and to comply with the requirements of the study protocol.

Who cannot join

  • 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.
  • 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.
  • History within the 60 days prior to the first administration of Investigational Product (IP) of use of cannabis, tobacco and/or nicotine-containing products.
  • History of drug abuse (either illicit or prescription) within two years prior to first administration of IP.
  • History of alcohol abuse at any time in the past five years from Screening.
  • 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.
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  • 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.
  • 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.
  • Hemoglobin less than the lower limit of normal or recent history (6 months prior to first dose) of iron deficient anemia.
  • Received a live vaccine or a vaccine for coronavirus 19 disease (COVID-19) within 4 weeks prior to Screening
  • Current or recent COVID-19 infection defined as:
  • positive result of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-V2) test at screening or Day-1, or
  • symptomatic COVID-19 infection within 30 days prior to Day-1, or
  • continuing COVID-19 long haul symptomatology regardless of when the initial COVID-19 infection occurred
  • Known hypersensitivity to avacopan or inactive ingredients of the avacopan capsules (including gelatin, polyethylene glycol, or Cremophor).
  • Participated in any clinical study of an Investigational Product within 30 days or of 5 half-lives prior to randomization.
  • 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.
  • 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
  • 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).
  • Use of alcohol-, caffeine-, or xanthine-containing products within 1 week prior to Day -1.
  • 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.
  • 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).
  • Use of over-the-counter medications, vitamins, or supplements (including omega-3 fish oils) within 7 days before Day 1 (first dose)
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Celerion

    Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: An Open-Label, Phase 1 Study to Evaluate the Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics of a Single Dose of Simvastatin in Healthy Volunteers

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.

Being tested
Avacopan, Simvastatin
Keywords
Avacopan, CCX168, Simvastatin

What participants receive

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

  • AvacopanDrug

    Also called CCX168

    Orally via capsules

  • SimvastatinDrug

    Orally via tablets

Study groups in NCT06207682
Study groupRoleWhat they receive
Arm 1: Avacopan and SimvastatinExperimentalA single dose of 40 mg simvastatin will be given orally in the morning on Day 1 and Day 10. The Day 10 dose of simvastatin will be co-administered with the morning dose of avacopan. On Days 3 through 11, avacopan will be given orally at 30 mg BID.
Receives: Drug: Avacopan; Drug: Simvastatin
Arm 2: Avacopan and SimvastatinExperimentalA single dose of 40 mg simvastatin will be given orally in the morning on Day 1 and Day 10. The Day 10 dose of simvastatin will be co-administered with the morning dose of avacopan. On Days 3 through 11, avacopan will be given orally at 60 mg BID.
Receives: Drug: Avacopan; Drug: Simvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Plasma Concentration (Cmax) of Simvastatin

    Measured: Up to Day 12

  2. Cmax of β-hydroxy-simvastatin Acid

    Measured: Up to Day 12

  3. Area Under the Plasma Concentration-time Curve from Time 0 to the Time Point of Last Quantifiable Plasma Concentration (AUClast) of Simvastatin

    Measured: Up to Day 12

  4. AUClast of β-hydroxy-simvastatin Acid

    Measured: Up to Day 12

  5. Area Under the Plasma Concentration-time Curve from Time 0 to Infinity (AUCinf) of Simvastatin

    Measured: Up to Day 12

  6. AUCinf of β-hydroxy-simvastatin Acid

    Measured: Up to Day 12

Secondary outcomes (5)

  1. Number of Participants Experiencing Adverse Events

    Measured: Up to Day 26

  2. Cmax of Avacopan

    Measured: Up to Day 12

  3. Cmax of Avacopan Metabolite M1

    Measured: Up to Day 12

  4. Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCtau) of Avacopan

    Measured: Up to Day 12

  5. AUCtau of Avacopan Metabolite M1

    Measured: Up to Day 12

Timeline

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

  1. First posted17 Jan 2024
  2. Study start28 Jun 2022
  3. Primary completion11 Aug 2022
  4. Study completion11 Aug 2022

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06207682
Sponsor's protocol ID
CL020_168
Status last verified
Dec 2023
First submitted
5 Jan 2024
Last updated
17 Jan 2024
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.

Publications

  • Miao S, Bekker P, Armas D, Lor M, Han Y, Webster K, Trivedi A. Pharmacokinetic Evaluation of the CYP3A4 and CYP2C9 Drug-Drug Interaction of Avacopan in 2 Open-Label Studies in Healthy Participants. Clin Pharmacol Drug Dev. 2024 May;13(5):517-533. doi: 10.1002/cpdd.1389. Epub 2024 Feb 29.

    PubMed 38423992

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Avacopan and Simvastatin in people with Healthy Volunteers, run by Amgen at 1 site in United States.

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 12 inclusion and 25 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 17 Jan 2024. 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 United States. 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?

Maximum Observed Plasma Concentration (Cmax) of Simvastatin (time frame: Up to Day 12). The study lists 6 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 NCT06207682, which also lists 1 linked publication.

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 17 Jan 2024.

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