Clinical trial NCT05444556: A Study of Imlunestrant (LY3484356) in Female Healthy Participants
Official title: The Effect of Imlunestrant on CYP2C8, CYP2C19, CYP2D6, P-gp, and BCRP Activity and the Effect of P-gp Inhibition on Imlunestrant Pharmacokinetics in Healthy Women of Non-childbearing Potential
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-07-06
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the effect of imlunestrant on repaglinide, omeprazole and dextromethorphan, and rosuvastatin and digoxin. The study will also investigate the effect of quinidine on imlunestrant in female healthy participants of non-childbearing potential. The safety and tolerability of imlunestrant will be investigated in female healthy participants of non-childbearing potential. The study will last approximately up to 32 days for each participant excluding the screening period.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy as determined by medical assessment
* Body mass index (BMI) within the range 18.0 to 35.0 kilograms per meter squared (kg/m²)
* Female participants of non childbearing potential.

Exclusion Criteria:

* Have known allergies to imlunestrant, related compounds or any components of the formulation, repaglinide, omeprazole, dextromethorphan, quinidine, rosuvastatin, or digoxin, as appropriate, or history of significant atopy.
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator
* Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing
* Use or intend to use any prescription medications/products within 14 days prior to first dose until completion of the follow-up visit, unless deemed acceptable by the investigator (or designee), including but not limited to medications that inhibit or induce cytochrome P450 (CYP) 2C8, CYP2C19, CYP2D6, P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP).

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Repaglinide
timeFrame: Predose up to 24 hours postdose
measure: PK: Maximum Observed Concentration (Cmax) of Repaglinide
timeFrame: Predose up to 24 hours postdose
measure: PK: AUC[0-∞] of Omeprazole
timeFrame: Predose up to 48 hours postdose
measure: PK: Cmax of Omeprazole
timeFrame: Predose up to 48 hours postdose
measure: PK: AUC[0-∞] of 5-hydroxyomeprazole
timeFrame: Predose up to 48 hours postdose
measure: PK: Cmax of 5-hydroxyomeprazole
timeFrame: Predose up to 48 hours postdose
measure: PK: AUC[0-∞] of Dextromethorphan
timeFrame: Predose up to 48 hours postdose
measure: PK: Cmax of Dextromethorphan
timeFrame: Predose up to 48 hours postdose
measure: PK: AUC[0-∞] of Dextrorphan
timeFrame: Predose up to 48 hours postdose
measure: PK: Cmax of Dextrorphan
timeFrame: Predose up to 48 hours postdose
measure: PK: AUC[0-∞] of Imlunestrant
timeFrame: Predose up to 168 hours postdose
measure: PK: Cmax of Imlunestrant
timeFrame: Predose up to 168 hours postdose
measure: PK: AUC[0-∞] of Rosuvastatin
timeFrame: Predose up to 120 hours postdose
measure: PK: Cmax of Rosuvastatin
timeFrame: Predose up to 120 hours postdose
measure: PK: AUC[0-∞] of Digoxin
timeFrame: Predose up to 120 hours postdose
measure: PK: Cmax of Digoxin
timeFrame: Predose up to 120 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Clinical Los Angeles, Inc
state: California
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: San Antonio
country: United States
facility: ICON Early Phase Services
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: