Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Amgen
Study ID
NCT05045638
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Rosuvastatin — DRUG
    Oral dose
  • Sotorasib — DRUG
    Oral dose

Study Details

A study to determine the effect of sotorasib on the pharmacokinetics (PK) of rosuvastatin, and to assess the PK of rosuvastatin when administered alone, in healthy participants.

Key Dates

Start date
Aug 20, 2021
Status verified
Oct 2022
Primary completion
Oct 10, 2021
Completion
Oct 10, 2021

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Rosuvastatin alone
  • Experimental: Rosuvastatin + sotorasib

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin [ Time Frame: Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours postdose following administration of rosuvastatin on Days 1 and 6 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Covance Clinical Research Unit - Daytona BeachDaytona BeachFlorida32117-5116-

Find similar trials in Daytona Beach, FL

By research site
Covance Clinical Research Unit - Daytona Beach· Daytona Beach, FL

Related Studies