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

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT05045638
Collaborator
(none)
13
1
2
1
12.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official 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
Actual Study Start Date :
Sep 9, 2021
Actual Primary Completion Date :
Oct 10, 2021
Actual Study Completion Date :
Oct 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rosuvastatin alone

Drug: Rosuvastatin
Oral dose

Experimental: Rosuvastatin + sotorasib

Drug: Rosuvastatin
Oral dose

Drug: Sotorasib
Oral dose
Other Names:
  • AMG 510
  • Outcome Measures

    Primary Outcome Measures

    1. Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin [Day 1 to Day 11]

    2. Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rosuvastatin [Day 1 to Day 11]

    3. AUC from Time Zero to Infinity (AUCinf) of Rosuvastatin [Day 1 to Day 11]

    Secondary Outcome Measures

    1. Number of Participants Reporting any Adverse Events [36 days]

    2. Number of Participants with Clinically Significant Abnormal Changes from Baseline in Clinical Laboratory Tests [Baseline (Day 1) to Day 11]

    3. Number of Participants with Clinically Significant Abnormal Changes from Baseline in 12-Leads Electrocardiogram (ECG) Findings [Baseline (screening) to Day 1]

    4. Number of Participants with Clinically Significant Abnormal Changes from Baseline in Vital Signs [Baseline (Day 1) to Day 11]

    5. Cmax of Sotorasib [Day 6 to Day 8]

    6. AUClast of Sotorasib [Day 6 to Day 8]

    7. AUCinf of Sotorasib [Day 6 to Day 8]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Covance Clinical Research Unit - Daytona Beach Daytona Beach Florida United States 32117-5116

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT05045638
    Other Study ID Numbers:
    • 20200426
    First Posted:
    Sep 16, 2021
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amgen
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 23, 2021