A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers

Part of paid clinical trials in Dallas, Texas.

Sponsor
Amgen
Study ID
NCT05497557
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

The primary objective of the study is to evaluate the effects of omeprazole (a proton-pump inhibitor) and an acidic beverage (Coca-Cola) on sotorasib pharmacokinetics (PK) when administered orally in healthy volunteers.

Key Dates

Start date
Jul 14, 2022
Status verified
Apr 2023
Primary completion
Sep 8, 2022
Completion
Sep 8, 2022

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Omeprazole + Sotorasib

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, and 48 hours postdose following administration of sotorasib on Days 1 and 9 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Labcorp Clinical Research Unit Inc.DallasTexas75247-

Find similar trials in Dallas, TX

By research site
Labcorp Clinical Research Unit Inc.· Dallas, TX

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