Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2022-09-12
2022-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Midazolam + Imlunestrant
Participants received 400 milligram (mg) Imlunestrant (2 × 200 mg) tablets administered once daily (QD) orally for 7 days on Days 3 to 9 and a single dose of 0.5 mg midazolam solution orally on Day 1 and Day 9 as per below dosing sequence:
Day 1: 0.5 mg midazolam alone Days 3 to 8: 400 mg imlunestrant QD alone Day 9: 0.5 mg midazolam + 400 mg imlunestrant There was a washout period of 8 days between doses of midazolam.
Midazolam
Administered orally.
Imlunestrant
Administered orally.
Interventions
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Midazolam
Administered orally.
Imlunestrant
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
FEMALE
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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LabCorp CRU, Inc.
Daytona Beach, Florida, United States
LabCorp CRU, Inc.
Dallas, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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J2J-MC-JZLK
Identifier Type: OTHER
Identifier Source: secondary_id
18416
Identifier Type: -
Identifier Source: org_study_id