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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Amgen
Study ID
NCT06207682
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Avacopan — DRUG
    Orally via capsules
  • Simvastatin — DRUG
    Orally via tablets

Study Details

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.

Key Dates

First listed
Jan 17, 2024
Start date
Jun 28, 2022
Status verified
Dec 2023
Primary completion
Aug 11, 2022
Completion
Aug 11, 2022

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Arm 1: Avacopan and Simvastatin
    A 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.
  • Experimental: Arm 2: Avacopan and Simvastatin
    A 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.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Simvastatin [ Time Frame: Up to Day 12 ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-

Find similar trials in Tempe, AZ

By research site
Celerion· Tempe, AZ

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