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

Amgen13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

RosuvastatinDRUG

Oral dose

SotorasibDRUG

Oral dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of Screening. * Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening. * Females of nonchildbearing potential Exclusion criteria: * Inability to swallow oral medication or history of malabsorption syndrome. * History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor. * Poor peripheral venous access. * History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease, including history of myolysis, not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Locations (1)

Covance Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, United States

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin

The pharmacokinetic (PK) parameters were determined using standard non-compartmental methods.

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

Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rosuvastatin

The PK parameters were determined using standard non-compartmental methods.

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

AUC From Time Zero to Infinity (AUCinf) of Rosuvastatin

The PK parameters were determined using standard non-compartmental methods.

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

Secondary Outcomes

Number of Participants Reporting Any Treatment-Emergent Adverse Events (TEAEs)

Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms (ECGs), and vital signs results were recorded as AEs.

Time frame: Day 1 to Day 41

Cmax of Sotorasib

The PK parameters were determined using standard non-compartmental methods.

Time frame: Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 6

AUClast of Sotorasib

The PK parameters were determined using standard non-compartmental methods.

Data from ClinicalTrials.gov

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