A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Amgen
Study ID
NCT05048784
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).

Key Dates

Start date
Aug 16, 2021
Status verified
Nov 2022
Primary completion
Feb 18, 2022
Completion
Feb 18, 2022

Study Design

Enrollment
145 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment Sequence ABC
    Participants will be administered sotorasib dose A orally in the following order: * Treatment A - as 3 tablets (test 1) * Treatment B - as 8 tablets (reference) * Treatment C - as 3 tablets (test 2)
  • Experimental: Treatment Sequence BAC
    Participants will be administered sotorasib dose A orally in the following order: * Treatment B - as 8 tablets (reference) * Treatment A - as 3 tablets (test 1) * Treatment C - as 3 tablets (test 2)

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Sotorasib for Treatments A and B [ Time Frame: Predose (Hour 0), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 1 (Period 1) and Day 4 (Period 2) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Covance Clinical Research UnitDaytona BeachFlorida32117-
Covance Clinical Research UnitDallasTexas75247-

Find similar trials in Daytona Beach, FL

By research site
Covance Clinical Research Unit· Daytona Beach, FLCovance Clinical Research Unit· Dallas, TX

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