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| ID | Type | Description | Link |
|---|---|---|---|
| J2J-MC-JZLK | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam + Imlunestrant | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Administered orally. |
| |
| Imlunestrant |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam | PK: AUC[0-∞] of Midazolam | Day 1: Predose, 0.25hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose |
| PK: Maximum Observed Concentration (Cmax) of Midazolam | PK: Cmax of Midazolam | Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose |
| Measure | Description | Time Frame |
|---|---|---|
| PK: AUC[0-∞] of 1'-Hydroxymidazolam | PK: AUC[0-∞] of 1'-hydroxymidazolam | Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose |
| PK: Cmax of 1'-Hydroxymidazolam |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LabCorp CRU, Inc. | Daytona Beach | Florida | 32117 | United States | ||
| LabCorp CRU, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Midazolam + Imlunestrant | Participants received 400 mg Imlunestrant (2 × 200 mg) tablets administered QD orally for 7 days on Days 3 to 9 and a single 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam | PK: AUC[0-∞] of Midazolam | All participants who received at least one dose of study drug (midazolam) and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Day 1: Predose, 0.25hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose |
|
Baseline Up to Day 18
All participants who received at least one dose of study drug (imlunestrant or midazolam). Participants were analyzed according to the treatment they actually received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.5 mg Midazolam | Participants received single dose of 0.5 mg midazolam solution orally on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 08005455979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 8, 2022 | Jan 8, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2022 | Jan 8, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| C000719756 | Imlunestrant |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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This is a fixed sequence, crossover study
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| Drug |
Administered orally. |
|
|
PK: Cmax of 1'-hydroxymidazolam |
| Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose |
| PK: Area Under the Concentration Versus Time Curve From Zero to 24 Hours at Steady State (AUC[0-24], ss) of Imlunestrant When Dosed in the Presence of Midazolam | PK: AUC[0-24], ss of Imlunestrant | Day 9: Predose, 0.25 h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose |
| PK: Maximum Observed Concentration at Steady State (Cmax, ss) of Imlunestrant When Dosed in the Presence of Midazolam | PK: Cmax, ss of Imlunestrant when dosed in the presence of Midazolam is evaluated. | Day 9: Predose, 0.25 h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose |
| Dallas |
| Texas |
| 75247 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Participants received 0.5 mg midazolam solution orally in combination with 400 mg Imlunestrant (2 × 200 mg) tablets administered orally on Day 9.
|
|
|
| Primary | PK: Maximum Observed Concentration (Cmax) of Midazolam | PK: Cmax of Midazolam | All participants who received at least one dose of study drug (midazolam) and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose |
|
|
|
|
| Secondary | PK: AUC[0-∞] of 1'-Hydroxymidazolam | PK: AUC[0-∞] of 1'-hydroxymidazolam | All participants who received at least one dose of study drug (midazolam) and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose |
|
|
|
|
| Secondary | PK: Cmax of 1'-Hydroxymidazolam | PK: Cmax of 1'-hydroxymidazolam | All participants who received at least one dose of study drug (midazolam) and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose; Day 9: Predose, 0.25h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24, 36, 48h postdose |
|
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve From Zero to 24 Hours at Steady State (AUC[0-24], ss) of Imlunestrant When Dosed in the Presence of Midazolam | PK: AUC[0-24], ss of Imlunestrant | All participants who received at least one dose of study drug (imlunestrant or midazolam) and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 9: Predose, 0.25 h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose |
|
|
|
| Secondary | PK: Maximum Observed Concentration at Steady State (Cmax, ss) of Imlunestrant When Dosed in the Presence of Midazolam | PK: Cmax, ss of Imlunestrant when dosed in the presence of Midazolam is evaluated. | All participants who received at least one dose of study drug (imlunestrant or midazolam) and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 9: Predose, 0.25 h, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 400 mg Imlunestrant | Participants received 400 mg imlunestrant (2 × 200 mg) tablets administered QD orally for 7 days on Days 3 to 8. | 0 | 20 | 0 | 20 | 5 | 20 |
| EG002 | 0.5 mg Midazolam + 400 mg Imlunestrant | Participants received 0.5 mg midazolam solution orally in combination with 400 mg Imlunestrant (2 × 200 mg) tablets administered orally on Day 9. | 0 | 20 | 0 | 20 | 1 | 20 |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
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| D006571 | Heterocyclic Compounds |