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| ID | Type | Description | Link |
|---|---|---|---|
| J2J-MC-JZLI | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imlunestrant + Repaglinide (Cohort 1) | Experimental | Participants received: Day 1: A single oral dose of 0.5 mg repaglinide administered alone. Day 3: A single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally. |
|
| mlunestrant + Omeprazole & Dextromethorphan (Cohort 2) | Experimental | Participants received: Day 1: A single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning. Day 3: A single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally. |
|
| Imlunestrant + Quinidine (Cohort 3) | Experimental | Participants received: Day 1: A single oral dose of 400 mg imlunestrant, administered in the morning. Days 15 to 17 and 19 to 24: Twice-daily oral doses of 200 mg quinidine, administered alone. Day 18: A single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen). |
|
| Imlunestrant + Rosuvastatin & Digoxin (Cohort 4) | Experimental | Participants received: Day 1: A single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin, administered in the morning. Day 10: A single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imlunestrant | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Repaglinide (Cohort 1) | PK: AUC[0-∞] of Repaglinide | Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
| PK: Maximum Observed Concentration (Cmax) of Repaglinide (Cohort 1) | PK: Cmax of Repaglinide | Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
| PK: AUC[0-∞] of Omeprazole (Cohort 2) | PK: AUC[0-∞] of Omeprazole | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
| PK: Cmax of Omeprazole (Cohort 2) | PK: Cmax of Omeprazole | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
| PK: AUC[0-∞] of Omeprazole Metabolite: 5-hydroxyomeprazole (Cohort 2) | 5-hydroxyomeprazole is a major metabolite of omeprazole. | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
| PK: Cmax of Omeprazole Metabolite: 5-hydroxyomeprazole (Cohort 2) | 5-hydroxyomeprazole is a major metabolite of omeprazole. | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
| PK: AUC[0-∞] of Dextromethorphan (Cohort 2) |
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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 |
|---|---|---|---|---|---|---|
| Altasciences Clinical Los Angeles, Inc | Cypress | California | 90630 | United States | ||
| Qps-Mra, Llc |
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| ID | Title | Description |
|---|---|---|
| FG000 | Imlunestrant + Repaglinide (Cohort 1) | Participants received: Day 1: A single oral dose of 0.5 mg repaglinide administered alone. Day 3: A single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally. |
| FG001 | Imlunestrant + Omeprazole & Dextromethorphan (Cohort 2) | Participants received: Day 1: A single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning. Day 3: A single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally. |
| FG002 | Imlunestrant + Quinidine (Cohort 3) | Participants received: Day 1: A single oral dose of 400 mg imlunestrant, administered in the morning. Days 15 to 17 and 19 to 24: Twice-daily oral doses of 200 mg quinidine, administered alone. Day 18: A single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen). |
| FG003 | Imlunestrant + Rosuvastatin & Digoxin (Cohort 4) | Participants received: Day 1: A single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin, administered in the morning. Day 10: A single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Imlunestrant + Repaglinide (Cohort 1) | Participants received: Day 1: A single oral dose of 0.5 mg repaglinide administered alone. Day 3: A single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally. |
| BG001 | Imlunestrant + Omeprazole & Dextromethorphan (Cohort 2) |
| 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 Repaglinide (Cohort 1) | PK: AUC[0-∞] of Repaglinide | All participants in Cohort 1 who received at least one dose of repaglinide and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
|
Cohort 1: up to 11 days, Cohort 2: up to 12 days, Cohort 3: up to 32 days, Cohort 4: up to 22 days
All participants who received at least one dose of study drug and have at least one post dose safety assessment. Based on the planned safety analysis, adverse events were collected per dose level of treatment regimen
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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 Repaglinide: Cohort 1 | Participants received a single oral dose of 0.5 mg repaglinide administered alone on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | 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 | Jun 26, 2022 | Nov 13, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2023 | Nov 13, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000719756 | Imlunestrant |
| C072379 | repaglinide |
| D009853 | Omeprazole |
| D003915 | Dextromethorphan |
| D011802 | Quinidine |
| D000068718 | Rosuvastatin Calcium |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
|
| Repaglinide | Drug | Administered orally. |
|
| Omeprazole | Drug | Administered orally. |
|
| Dextromethorphan | Drug | Administered orally. |
|
| Quinidine | Drug | Administered orally. |
|
| Rosuvastatin | Drug | Administered orally. |
|
| Digoxin | Drug | Administered orally. |
|
PK: AUC[0-∞] of Dextromethorphan |
| Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
| PK: Cmax of Dextromethorphan (Cohort 2) | PK: Cmax of Dextromethorphan | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
| PK: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Tlast (AUC[0-tlast]) of Dextromethorphan Metabolite: Dextrorphan (Cohort 2) | Dextrorphan is a major metabolite of Dextromethorphan. | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
| PK: Cmax of Dextromethorphan Metabolite: Dextrorphan (Cohort 2) | Dextrorphan is a major metabolite of Dextromethorphan. | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
| PK: AUC[0-∞] of Imlunestrant (Cohort 3) | PK: AUC[0-∞] of Imlunestrant | Day 1 and Day 18: Predose, 1, 2, 3, 4, 5, 6 ,8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 h post dose |
| PK: Cmax of Imlunestrant (Cohort 3) | PK: Cmax of Imlunestrant | Day 1 and Day 18: Predose, 1, 2, 3, 4, 5, 6 ,8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 h post dose |
| PK: AUC[0-∞] of Rosuvastatin (Cohort 4) | PK: AUC[0-∞] of Rosuvastatin | Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose |
| PK: Cmax of Rosuvastatin (Cohort 4) | PK: Cmax of Rosuvastatin | Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose |
| PK: AUC[0-∞] of Digoxin (Cohort 4) | PK: AUC[0-∞] of Digoxin | Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose |
| PK: Cmax of Digoxin (Cohort 4) | PK: Cmax of Digoxin | Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose |
| South Miami |
| Florida |
| 33143-4875 |
| United States |
| ICON Early Phase Services | San Antonio | Texas | 78209 | United States |
Participants received: Day 1: A single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning. Day 3: A single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally. |
| BG002 | Imlunestrant + Quinidine (Cohort 3) | Participants received: Day 1: A single oral dose of 400 mg imlunestrant, administered in the morning. Days 15 to 17 and 19 to 24: Twice-daily oral doses of 200 mg quinidine, administered alone. Day 18: A single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen). |
| BG003 | Imlunestrant + Rosuvastatin & Digoxin (Cohort 4) | Participants received: Day 1: A single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin, administered in the morning. Day 10: A single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally. |
| BG004 | Total | Total of all reporting groups |
| 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 a single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally on Day 3.
|
|
| Primary | PK: Maximum Observed Concentration (Cmax) of Repaglinide (Cohort 1) | PK: Cmax of Repaglinide | All participants in Cohort 1 who received at least one dose of repaglinide and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per millilitre (ng/mL) | Day 1 and Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose |
|
|
|
| Primary | PK: AUC[0-∞] of Omeprazole (Cohort 2) | PK: AUC[0-∞] of Omeprazole | All participants in Cohort 2, who received at least one dose of omeprazole and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
|
|
|
| Primary | PK: Cmax of Omeprazole (Cohort 2) | PK: Cmax of Omeprazole | All participants in Cohort 2, who received at least one dose of omeprazole and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
|
|
|
| Primary | PK: AUC[0-∞] of Omeprazole Metabolite: 5-hydroxyomeprazole (Cohort 2) | 5-hydroxyomeprazole is a major metabolite of omeprazole. | All participants in Cohort 2, who received at least one dose of omeprazole and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
|
|
|
| Primary | PK: Cmax of Omeprazole Metabolite: 5-hydroxyomeprazole (Cohort 2) | 5-hydroxyomeprazole is a major metabolite of omeprazole. | All participants in Cohort 2, who received at least one dose of omeprazole and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
|
|
|
| Primary | PK: AUC[0-∞] of Dextromethorphan (Cohort 2) | PK: AUC[0-∞] of Dextromethorphan | All Cohort 2 participants who received at least one dose of dextromethorphan and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
|
|
|
| Primary | PK: Cmax of Dextromethorphan (Cohort 2) | PK: Cmax of Dextromethorphan | All Cohort 2 participants who received at least one dose of dextromethorphan and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Tlast (AUC[0-tlast]) of Dextromethorphan Metabolite: Dextrorphan (Cohort 2) | Dextrorphan is a major metabolite of Dextromethorphan. | All Cohort 2 participants who received at least one dose of dextromethorphan and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
|
|
|
| Primary | PK: Cmax of Dextromethorphan Metabolite: Dextrorphan (Cohort 2) | Dextrorphan is a major metabolite of Dextromethorphan. | All Cohort 2 participants who received at least one dose of dextromethorphan and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, and 24 h postdose; Day 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 h postdose |
|
|
|
| Primary | PK: AUC[0-∞] of Imlunestrant (Cohort 3) | PK: AUC[0-∞] of Imlunestrant | All cohort 3 participants who received at least one dose of imlunestrant and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1 and Day 18: Predose, 1, 2, 3, 4, 5, 6 ,8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 h post dose |
|
|
|
| Primary | PK: Cmax of Imlunestrant (Cohort 3) | PK: Cmax of Imlunestrant | All cohort 3 participants who received at least one dose of imlunestrant and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 and Day 18: Predose, 1, 2, 3, 4, 5, 6 ,8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 h post dose |
|
|
|
| Primary | PK: AUC[0-∞] of Rosuvastatin (Cohort 4) | PK: AUC[0-∞] of Rosuvastatin | All cohort 4 participants who received at least one dose of rosuvastatin and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose |
|
|
|
| Primary | PK: Cmax of Rosuvastatin (Cohort 4) | PK: Cmax of Rosuvastatin | All cohort 4 participants who received at least one dose of rosuvastatin and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose |
|
|
|
| Primary | PK: AUC[0-∞] of Digoxin (Cohort 4) | PK: AUC[0-∞] of Digoxin | All cohort 4 participants who received at least one dose of digoxin and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose |
|
|
|
| Primary | PK: Cmax of Digoxin (Cohort 4) | PK: Cmax of Digoxin | All cohort 4 participants who received at least one dose of digoxin and had evaluable PK data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 h post dose; Day 10: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 h post dose |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 2 |
| 27 |
| EG001 | 800 mg Imlunestrant + 0.5 mg Repaglinide: Cohort 1 | Participants received a single oral dose of 800 mg imlunestrant, followed approximately 2 hours later by 0.5 mg repaglinide, both administered orally on Day 3. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | 20 mg Omeprazole + 30 mg Dextromethorphan: Cohort 2 | Participants received a single oral dose of 20 mg omeprazole and 30 mg dextromethorphan, administered in the morning on Day 1. | 0 | 27 | 0 | 27 | 3 | 27 |
| EG003 | 800 mg Imlunestrant + 20 mg Omeprazole + 30 mg Dextromethorphan: Cohort 2 | Participants received a single oral dose of 800 mg imlunestrant, followed immediately by 20 mg omeprazole and 30 mg dextromethorphan, all administered orally on Day 3. | 0 | 27 | 0 | 27 | 3 | 27 |
| EG004 | 400 mg Imlunestrant (Day 1): Cohort 3 | Participants received a single oral dose of 400 mg imlunestrant administered alone on Day 1. | 0 | 32 | 0 | 32 | 9 | 32 |
| EG005 | 200 mg Quinidine BID (Days 15 to 17): Cohort 3 | Participants received twice-daily oral doses of 200 mg quinidine, administered alone from days 15 to 17. | 0 | 32 | 0 | 32 | 3 | 32 |
| EG006 | 400 mg Imlunestrant + 200 mg Quinidine BID (Day 18): Cohort 3 | Participants received a single oral dose of 400 mg imlunestrant administered in combination with 200 mg quinidine (quinidine was dosed twice on this day as part of the regular regimen) on day 18. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG007 | 200 mg Quinidine BID (Days 19 to 24): Cohort 3 | Participants received BID oral doses of 200 mg quinidine, administered alone from Days 19 to 24. | 0 | 31 | 0 | 31 | 4 | 31 |
| EG008 | 10 mg Rosuvastatin + 0.25 mg Digoxin: Cohort 4 | Participants received a single oral dose of 10 mg rosuvastatin and 0.25 mg digoxin on Day 1. | 0 | 27 | 0 | 27 | 0 | 27 |
| EG009 | 400 mg Imlunestrant + 10 mg Rosuvastatin + 0.25 mg Digoxin: Cohort 4 | Participants received a single oral dose of 400 mg imlunestrant, administered in combination with 10 mg rosuvastatin and 0.25 mg digoxin, all administered orally on Day 10. | 0 | 26 | 0 | 26 | 1 | 26 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002930 | Cinchona Alkaloids |
| D011812 | Quinuclidines |
| D011804 | Quinolines |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D011743 | Pyrimidines |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |