A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Amgen
Study ID
NCT05327491
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 the study is to compare the pharmacokinetics (PK) of sotorasib administered orally as 1 tablet under fasted conditions to sotorasib administered orally as 2 tablets under fasted conditions.

Key Dates

Start date
Mar 21, 2022
Status verified
Mar 2023
Primary completion
Jul 17, 2022
Completion
Jul 17, 2022

Study Design

Enrollment
146 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Sequence ABC
    Participants will be administered sotorasib orally in the following order: Period 1 - as 1 tablet (test 1) Period 2 - as 2 tablets (reference) Period 3 - as 1 tablet (test 2)
  • Experimental: Treatment Sequence BAC
    Participants will be administered sotorasib orally in the following order: Period 1 - as 2 tablets (reference) Period 2 - as 1 tablet (test 1) Period 3 - as 1 tablet (test 2)

Primary Outcome Measure

Period 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Sotorasib [ Time Frame: Predose, 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 the 1st day of each period (Days 1 and 4) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Labcorp Clinical Research Unit - Daytona BeachDaytona BeachFlorida32117-5116-
Miami Research Associates LLC - Main Campus / Late PhaseSouth MiamiFlorida33143-5026-
Labcorp Clinical Research Unit - DallasDallasTexas75247-4989-
Labcorp Clinical Research Unit - MadisonMadisonWisconsin53704-2526-

Find similar trials in Daytona Beach, FL

By research site
Labcorp Clinical Research Unit - Daytona Beach· Daytona Beach, FLMiami Research Associates LLC - Main Campus / Late Phase· South Miami, FLLabcorp Clinical Research Unit - Dallas· Dallas, TXLabcorp Clinical Research Unit - Madison· Madison, WI

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