Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment

Part of paid clinical trials in Tustin, California.

Sponsor
Amgen
Study ID
NCT04887064
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Sotorasib — DRUG
    Sotorasib will be administered as an oral tablet.

Study Details

The main purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of sotorasib administered in participants with moderate or severe hepatic impairment compared to participants with normal hepatic function.

Key Dates

Start date
Apr 22, 2021
Status verified
Jan 2023
Primary completion
Mar 9, 2022
Completion
Mar 9, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Normal Hepatic Function
  • Experimental: Moderate Hepatic Impairment
  • Experimental: Severe Hepatic Impairment

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Sotorasib [ Time Frame: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Orange County Research CenterTustinCalifornia92780-
Clinical Pharmacology Of Miami LLCMiamiFlorida33014-
Orlando Clinical Research CenterOrlandoFlorida32809-
American Research CorporationSan AntonioTexas78215-
Pinnacle Clinical Research - San AntonioSan AntonioTexas78229-

Find similar trials in Tustin, CA

By research site
Orange County Research Center· Tustin, CAClinical Pharmacology Of Miami LLC· Miami, FLOrlando Clinical Research Center· Orlando, FLAmerican Research Corporation· San Antonio, TXPinnacle Clinical Research - San Antonio· San Antonio, TX

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