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Completed

NCT Number: NCT05045638

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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, 32117-5116, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin

Drug

Oral dose

Sotorasib

Drug

Oral dose

Other names: AMG 510

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin

    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

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

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

    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

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

  3. AUC From Time Zero to Infinity (AUCinf) of Rosuvastatin

    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

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

Secondary outcomes

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

    Time frame: Day 1 to Day 41

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

  2. Cmax of Sotorasib

    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

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

  3. AUClast of Sotorasib

    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

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

  4. AUCinf of Sotorasib

    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

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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2021
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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