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A Study of Imlunestrant (LY3484356) in Healthy Women

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05509816
Collaborator
(none)
20
Enrollment
2
Locations
1
Arm
1.9
Anticipated Duration (Months)
10
Patients Per Site
5.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the effect of imlunestrant (LY3484356) when administered orally on the levels of midazolam in the blood stream in healthy women of non-childbearing potential. The study will also evaluate the safety and tolerability of imlunestrant in healthy women of non-childbearing potential. This study will last up to approximately 6 weeks for each participant including the screening period.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Effect of Repeat Dosing of Imlunestrant on CYP3A Activity in Healthy Women of Non-childbearing Potential
Anticipated Study Start Date :
Sep 12, 2022
Anticipated Primary Completion Date :
Nov 8, 2022
Anticipated Study Completion Date :
Nov 8, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Midazolam + Imlunestrant

Midazolam administered orally alone on day 1 followed by imlunestrant administered orally alone on days 3 to 8. On day 9, midazolam is administered orally in combination with imlunestrant orally.

Drug: Midazolam
Administered orally.

Drug: Imlunestrant
Administered orally.
Other Names:
  • LY3484356

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam [Predose up to 48 hours postdose]

      PK: AUC[0-∞] of Midazolam

    2. PK: Maximum Observed Concentration (Cmax) of Midazolam [Predose up to 48 hours postdose]

      PK: Cmax of Midazolam

    Secondary Outcome Measures

    1. PK: AUC[0-∞] of 1'-hydroxymidazolam [Predose up to 48 hours postdose]

      PK: AUC[0-∞] of 1'-hydroxymidazolam

    2. PK: Cmax of 1'-hydroxymidazolam [Predose up to 48 hours postdose]

      PK: Cmax of 1'-hydroxymidazolam

    3. PK: Area Under the Concentration Versus Time Curve From Zero to 24 hours at steady state (AUC[0-24], ss) of Imlunestrant [Predose up to 24 hours postdose]

      PK: AUC[0-24], ss of Imlunestrant

    4. PK: Maximum Observed Concentration at steady state (Cmax, ss) of Imlunestrant [Predose up to 24 hours postdose]

      PK: Cmax, ss of Imlunestrant

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Women not of childbearing potential

    • Participants who are overtly healthy as determined by medical assessment

    • Participants with body mass index (BMI) of 18.0 and 35.0 kilograms per meter squared (kg/m²), inclusive

    Exclusion Criteria:

    • Have known allergies to imlunestrant, related compounds or any components of the formulation or midazolam

    • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder

    • Use or intend to use medications that are substrate drugs of P-glycoprotein

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Labcorp Clinical Research Unit Inc, Daytona Beach Florida United States 32117
    2 Labcorp Clinical Research Unit Inc. Dallas Texas United States 75247

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05509816
    Other Study ID Numbers:
    • 18416
    • J2J-MC-JZLK
    First Posted:
    Aug 22, 2022
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 15, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Midazolam

    Study Results

    No Results Posted as of Aug 22, 2022