Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Lipid Regulating Agents

All Drugs and Chemicals

Antineoplastic Agents

Bone Density Conservation Agents

Rosuvastatin Calcium

Sotorasib

Calcium

Calcium, Dietary

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Enzyme Inhibitors

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Rosuvastatin

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.

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

A Phase I, Open-label, Fixed Sequence Crossover Study to Investigate the Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin, a Breast Cancer Resistance Protein Substrate, in Healthy Subjects

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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

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

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

Amgen

The safety population included all participants who received at least 1 dose of sotorasib or rosuvastatin and had at least 1 postdose safety assessment.

On Day 1, rosuvastatin was administered as a single 10 mg dose. All participants fasted overnight (at least 10 hours) until 4 hours postdose and refrained from consuming water for 1 hour prior to dosing and 2 hours postdose.

On Day 6, sotorasib was administered as a single 960 mg dose and was followed immediately by a single dose of 10 mg rosuvastatin. All participants fasted overnight (at least 10 hours) until 4 hours postdose and refrained from consuming water for 1 hour prior to dosing and 2 hours postdose.

Sotorasib + Rosuvastatin

On Day 1, rosuvastatin was administered as a single 10 mg dose. On Day 6, sotorasib was administered as a single 960 mg dose and was followed immediately by a single dose of 10 mg rosuvastatin. All participants fasted overnight (at least 10 hours) until 4 hours postdose and refrained from consuming water for 1 hour prior to dosing and 2 hours postdose.

All Participants

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Study Director

The ratios of geometric least squares means (GLSMs) and confidence intervals (CIs) were obtained by taking the exponential of the corresponding differences and CIs on the natural-log (ln) scale.

The PK population included all participants who received at least 1 dose of rosuvastatin or sotorasib and had evaluable PK data.

Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin

The ratios of GLSMs and CIs were obtained by taking the exponential of the corresponding differences and CIs on the ln scale.

Spots Global Cancer Trial Database for Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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