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| ID | Type | Description | Link |
|---|---|---|---|
| J2J-MC-JZLD | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the amount of LY3484356 that is found in the blood stream and how long the body takes to get rid of it when given with and without food. Participants are healthy females of non-childbearing potential. The study will also evaluate the tolerability and safety of LY3484356 by collecting the information about any side effects that may occur. The participant's involvement with the study will last approximately 27 days, not including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Sequence 1: 400 mg LY3484356 Fasted/ 400 mg LY3484356 Fed | Experimental | Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 administered as single doses orally with (fed) or without food (fasted) as below: Period 1: Single dose of 400 mg LY3484356 in the fasted state. Period 2: Single dose of 400 mg LY3484356 in the fed state. There was a washout period of 4 days between doses of LY3484356 |
|
| Cohort 1 Sequence 2: 400 mg LY3484356 Fed/ 400 mg LY3484356 Fasted | Experimental | Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 administered as single doses orally with (fed) or without food (fasted) as below: Period 1: Single dose of 400 mg LY3484356 in the fed state. Period 2: Single dose of 400 mg LY3484356 in the fasted state. There was a washout period of 4 days between doses of LY3484356. |
|
| Cohort 2: LY3484356 + Omeprazole | Experimental | Participants received single dose of LY3484356 and a single dose of omeprazole alone and in combination administered orally as below: Day 1: 400 mg LY3484356 alone Days 5 to 8: 40 mg omeprazole alone once daily Day 9: 400 mg LY3484356 + 40 mg omeprazole once There was a washout period of 8 days between doses of LY3484356. |
|
| Cohort 3: LY3484356 + Itraconazole | Experimental | Participants received single dose of LY3484356 and a single dose of Itraconazole alone and in combination administered orally as below: Day 1: 200 mg LY3484356 alone Days 5 to 9: 200 mg itraconazole alone (twice on Day 5 [dose separated by approximately 12 hours], then once daily on Days 6 through 9) Day 10: 200 mg LY3484356 + 200 mg itraconazole once (coadministered with the morning dose) Days 11 to 16: 200 mg itraconazole alone once daily. There was a washout period of 9 days between doses of LY3484356. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3484356 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 (Cohort 1) | PK: AUC[0-∞] of LY3484356 | Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours (h) postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose |
| PK: AUC[0-∞] of LY3484356 (Cohort 2) | PK: AUC[0-∞] of LY3484356 | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
| PK: AUC[0-∞] of LY3484356 (Cohort 3) | PK: AUC[0-∞] of LY3484356 | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
| PK: AUC[0-∞] of LY3484356 (Cohort 4) | AUC[0-∞] of LY3484356 | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
| PK: Time of Maximum Observed Concentration (Tmax) of LY3484356 (Cohort 1) | PK: Tmax of LY3484356 | Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose |
| PK: Tmax of LY3484356 (Cohort 2) | PK: Tmax of LY3484356 | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
| PK: Tmax of LY3484356 (Cohort 3) |
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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 | ||
| Covance Dallas |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 Sequence 1: 400 mg LY3484356 Fasted/ 400 mg LY3484356 Fed | Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 received as single dose with (fed) or without food (fasted) administered orally as below: Period 1: Single dose of 400 mg LY3484356 in the fasted state. Period 2: Single dose of 400 mg LY3484356 in the fed state. There was a washout period of 4 days between doses of LY3484356 |
| FG001 | Cohort 1 Sequence 2: 400 mg LY3484356 Fed/ 400 mg LY3484356 Fasted | Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 received as single dose with (fed) or without food (fasted) administered orally as below: Period 1: Single dose of 400 mg LY3484356 in the fed state. Period 2: Single dose of 400 mg LY3484356 in the fasted state. There was a washout period of 4 days between doses of LY3484356. |
| FG002 | Cohort 2: LY3484356 + Omeprazole | Participants received single dose of LY3484356 and a single oral dose of omeprazole alone and in combination administered orally as below: Day 1: 400 mg LY3484356 alone Days 5 to 8: 40 mg omeprazole alone once daily Day 9: 400 mg LY3484356 + 40 mg omeprazole once There was a washout period of 8 days between doses of LY3484356. |
| FG003 | Cohort 3: LY3484356 + Itraconazole | Participants received single dose of LY3484356 and a single oral dose of Itraconazole alone and in combination administered orally as below: Day 1: 200 mg LY3484356 alone Days 5 to 9: 200 mg itraconazole alone (twice on Day 5 [dose separated by approximately 12 hours], then once daily on Days 6 through 9) Day 10: 200 mg LY3484356 + 200 mg itraconazole once (coadministered with the morning dose) Days 11 to 16: 200 mg itraconazole alone once daily. There was a washout period of 9 days between doses of LY3484356. |
| FG004 | Cohort 4: LY3484356 + Carbamazepine | Participants received single dose of LY3484356 and a single oral dose of carbamazepine alone and in combination administered orally as below: Day 1: 400 mg LY3484356 alone Days 6 to 8: 100 mg carbamazepine twice daily (BID) alone Days 9 to 11: 200 mg carbamazepine BID alone Days 12 to 17: 300 mg carbamazepine BID alone Day 18: 300 mg carbamazepine BID + 400 mg LY3484356 (coadministered with morning dose) Days 19 to 22: 300 mg carbamazepine BID alone Day 23: 300 mg carbamazepine alone (morning dose only). There was a washout period of 17 days between doses of LY3484356. |
| FG005 | Cohort 5: Carbamazepine + Midazolam | Participants received single dose of Carbamazepine and a single oral dose of midazolam alone and in combination administered orally as below: Day 1: 1.2 mg midazolam alone Days 2 to 4: 100 mg carbamazepine BID alone Days 5 to 7: 200 mg carbamazepine BID alone Days 8 to 10: 300 mg carbamazepine BID alone Day 11: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose) Days 12 to 13: 300 mg carbamazepine BID alone Day 14: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| |||||||||||||||||||||
| Period 2 |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Sequence 1/Sequence 2 | Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 received as single dose with (fed) or without food (fasted) administered orally as below: Cohort 1 Sequence 1: Period 1: Single dose of 400 mg LY3484356 in the fed state. Period 2: Single dose of 400 mg LY3484356 in the fasted state. Cohort 1 Sequence 2: Period 1: Single dose of 400 mg LY3484356 in the fasted state. Period 2: Single dose of 400 mg LY3484356 in the fed state. There was a washout period of 4 days between doses of LY3484356 |
| 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 LY3484356 (Cohort 1) | PK: AUC[0-∞] of LY3484356 | All enrolled participants in cohort 1 who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours (h) postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose |
|
Cohort 1: up to 19 days, Cohort 2: up to 24 days, Cohort 3: up to 27 days, Cohort 4: up to 37 days, and Cohort 5: up to 25 days
All enrolled participants who received at least one dose of study drug. Based on the planned safety analysis, adverse events were collected per each 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 | Cohort 1: 400 mg LY3484356 Fasted | Participants received single oral dose of 400 mg LY3484356 in the fasted state. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis e | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | 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 | Oct 6, 2021 | Jan 4, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 10, 2021 | Jan 4, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000719756 | Imlunestrant |
| D009853 | Omeprazole |
| D017964 | Itraconazole |
| D002220 | Carbamazepine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Cohort 4: LY3484356 + Carbamazepine | Experimental | Participants received single dose of LY3484356 and a single dose of carbamazepine alone and in combination administered orally as below: Day 1: 400 mg LY3484356 alone Days 6 to 8: 100 mg carbamazepine BID alone Days 9 to 11: 200 mg carbamazepine BID alone Days 12 to 17: 300 mg carbamazepine BID alone Day 18: 300 mg carbamazepine BID + 400 mg LY3484356 (coadministered with morning dose) Days 19 to 22: 300 mg carbamazepine BID alone Day 23: 300 mg carbamazepine alone (morning dose only). There was a washout period of 17 days between doses of LY3484356. |
|
| Cohort 5: Carbamazepine + Midazolam | Experimental | Participants received single dose of Carbamazepine and a single dose of midazolam alone and in combination administered orally as below: Day 1: 1.2 mg midazolam alone Days 2 to 4: 100 mg carbamazepine BID alone Days 5 to 7: 200 mg carbamazepine BID alone Days 8 to 10: 300 mg carbamazepine BID alone Day 11: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose) Days 12 to 13: 300 mg carbamazepine BID alone Day 14: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose). |
|
| Omeprazole | Drug | Administered orally. |
|
| Itraconazole | Drug | Administered orally. |
|
| Carbamazepine | Drug | Administered orally. |
|
| Midazolam | Drug | Administered orally. |
|
PK: Tmax of LY3484356 |
| Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
| PK: Tmax of LY3484356 (Cohort 4) | Tmax of LY3484356 | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
| PK: Maximum Observed Concentration (Cmax) of LY3484356 (Cohort 1) | Cmax of LY3484356 | Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose |
| PK: Cmax of LY3484356 (Cohort 2) | Cmax of LY3484356 | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
| PK: Cmax of LY3484356 (Cohort 3) | Cmax of LY3484356 | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
| PK: Cmax of LY3484356 (Cohort 4) | Cmax of LY3484356 | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
| Dallas |
| Texas |
| 75247 |
| United States |
| Adverse Event |
|
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Cohort 2: LY3484356 + Omeprazole | Participants received single dose of LY3484356 and a single dose of omeprazole alone and in combination administered orally as below: Day 1: 400 mg LY3484356 alone Days 5 to 8: 40 mg omeprazole alone once daily Day 9: 400 mg LY3484356 + 40 mg omeprazole once There was a washout period of 8 days between doses of LY3484356. |
| BG002 | Cohort 3: LY3484356 + Itraconazole | Participants received single dose of LY3484356 and a single dose of Itraconazole alone and in combination administered orally as below: Day 1: 200 mg LY3484356 alone Days 5 to 9: 200 mg itraconazole alone (twice on Day 5 [dose separated by approximately 12 hours], then once daily on Days 6 through 9) Day 10: 200 mg LY3484356 + 200 mg itraconazole once (coadministered with the morning dose) Days 11 to 16: 200 mg itraconazole alone once daily. There was a washout period of 9 days between doses of LY3484356 |
| BG003 | Cohort 4: LY3484356 + Carbamazepine | Participants received single dose of LY3484356 and a single dose of carbamazepine alone and in combination administered orally as below: Day 1: 400 mg LY3484356 alone Days 6 to 8: 100 mg carbamazepine BID alone Days 9 to 11: 200 mg carbamazepine BID alone Days 12 to 17: 300 mg carbamazepine BID alone Day 18: 300 mg carbamazepine BID + 400 mg LY3484356 (coadministered with morning dose) Days 19 to 22: 300 mg carbamazepine BID alone Day 23: 300 mg carbamazepine alone (morning dose only). There was a washout period of 17 days between doses of LY3484356. |
| BG004 | Cohort 5: Carbamazepine + Midazolam | Participants received single dose of Carbamazepine and a single dose of midazolam alone and in combination administered orally as below: Day 1: 1.2 mg midazolam alone Days 2 to 4: 100 mg carbamazepine BID alone Days 5 to 7: 200 mg carbamazepine BID alone Days 8 to 10: 300 mg carbamazepine BID alone Day 11: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose) Days 12 to 13: 300 mg carbamazepine BID alone Day 14: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose) |
| BG005 | 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 single oral dose of 400 mg LY3484356 in the fed state. |
|
|
| Primary | PK: AUC[0-∞] of LY3484356 (Cohort 2) | PK: AUC[0-∞] of LY3484356 | All enrolled participants in cohort 2 who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
|
|
|
| Primary | PK: AUC[0-∞] of LY3484356 (Cohort 3) | PK: AUC[0-∞] of LY3484356 | All enrolled participants in cohort 3 who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
|
|
|
| Primary | PK: AUC[0-∞] of LY3484356 (Cohort 4) | AUC[0-∞] of LY3484356 | All enrolled participants in cohort 4 who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
|
|
|
| Primary | PK: Time of Maximum Observed Concentration (Tmax) of LY3484356 (Cohort 1) | PK: Tmax of LY3484356 | All enrolled participants in cohort 1 who received at least one dose of study drug and had evaluable PK data. | Posted | Median | Full Range | hours | Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose |
|
|
|
| Primary | PK: Tmax of LY3484356 (Cohort 2) | PK: Tmax of LY3484356 | All enrolled participants in cohort 2 who received at least one dose of study drug and had evaluable PK data. | Posted | Median | Full Range | hours | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
|
|
|
| Primary | PK: Tmax of LY3484356 (Cohort 3) | PK: Tmax of LY3484356 | All enrolled participants in cohort 3 who received at least one dose of study drug and had evaluable PK data. | Posted | Median | Full Range | hours | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
|
|
|
| Primary | PK: Tmax of LY3484356 (Cohort 4) | Tmax of LY3484356 | All enrolled participants in cohort 4 who received at least one dose of study drug and had evaluable PK data. | Posted | Median | Full Range | hours | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
|
|
|
| Primary | PK: Maximum Observed Concentration (Cmax) of LY3484356 (Cohort 1) | Cmax of LY3484356 | All enrolled participants in cohort 1 who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per millilitre (ng/mL) | Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose |
|
|
|
| Primary | PK: Cmax of LY3484356 (Cohort 2) | Cmax of LY3484356 | All enrolled participants in cohort 2 who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
|
|
|
| Primary | PK: Cmax of LY3484356 (Cohort 3) | Cmax of LY3484356 | All enrolled participants in cohort 3 who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
|
|
|
| Primary | PK: Cmax of LY3484356 (Cohort 4) | Cmax of LY3484356 | All enrolled participants in cohort 4 who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Cohort 1: 400 mg LY3484356 Fed | Participants received single oral dose of 400 mg LY3484356 in the fed state. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG002 | Cohort 2: 400 mg LY3484356 (Day 1) | Participants received 400 mg LY3484356 alone administered orally (Day 1). | 0 | 10 | 0 | 10 | 2 | 10 |
| EG003 | Cohort 2: 40 mg Omeprazole (Days 5 to 8) | Participants received 40 mg omeprazole administered orally once daily (Days 5 to 8). | 0 | 10 | 0 | 10 | 2 | 10 |
| EG004 | Cohort 2: 400 mg LY3484356 + 40 mg Omeprazole (Day 9) | Participants received 400 mg LY3484356 + 40 mg omeprazole administered orally (Day 9). | 0 | 9 | 0 | 9 | 1 | 9 |
| EG005 | Cohort 3: 200 mg LY3484356 (Day 1) | Participants received 200 mg LY3484356 administered orally (Day 1) | 0 | 20 | 0 | 20 | 5 | 20 |
| EG006 | Cohort 3: 200 mg Itraconazole (Days 5 to 9) | Participants received 200 mg itraconazole administered orally alone (twice on Day 5 [dose separated by approximately 12 hours], then once daily on Days 6 through 9) | 0 | 20 | 0 | 20 | 8 | 20 |
| EG007 | Cohort 3: 200 mg LY3484356 + 200 mg Itraconazole (Days 10 to 16) | Participants received 200 mg LY3484356 + 200 mg itraconazole administered orally once (co-administered with the morning dose) (Day 10), then 200 mg itraconazole administered orally alone once daily (Days 11 to 16). | 0 | 20 | 0 | 20 | 2 | 20 |
| EG008 | Cohort 4: 400 mg LY3484356 (Day 1) | Participants received 400 mg LY3484356 administered orally (Day 1) | 0 | 29 | 0 | 29 | 2 | 29 |
| EG009 | Cohort 4: 100 mg Carbamazepine (Days 6 to 8) | Participants received 100 mg carbamazepine administered orally BID (Days 6 to 8). | 0 | 28 | 0 | 28 | 1 | 28 |
| EG010 | Cohort 4: 200 mg Carbamazepine (Days 9 to 11) | Participants received 200 mg carbamazepine administered orally BID (Days 9 to 11). | 0 | 28 | 0 | 28 | 6 | 28 |
| EG011 | Cohort 4: 300 mg Carbamazepine + 400 mg LY3484356 (Days 12 to 22) | Participants received 300 mg carbamazepine administered orally BID (Days 12 to 17), then 300 mg carbamazepine BID + 400 mg LY3484356 (co-administered with morning dose) administered orally (Day 18) followed by 300 mg carbamazepine administered orally BID (Day 19 to 22). | 0 | 28 | 1 | 28 | 16 | 28 |
| EG012 | Cohort 4: 300 mg Carbamazepine (Day 23) | Participants received 300 mg carbamazepine (morning dose only) administered orally (Day 23). | 0 | 20 | 0 | 20 | 3 | 20 |
| EG013 | Cohort 5: 1.2 mg Midazolam (Day 1) | Participants received 1.2 mg midazolam administered orally (Day 1). | 0 | 15 | 0 | 15 | 0 | 15 |
| EG014 | Cohort 5: 100 mg Carbamazepine (Days 2 to 4) | Participants received 100 mg carbamazepine administered orally BID (Days 2 to 4). | 0 | 15 | 0 | 15 | 1 | 15 |
| EG015 | Cohort 5: 200 mg Carbamazepine (Days 5 to 7) | Participants received 200 mg carbamazepine administered orally BID (Days 5 to 7). | 0 | 15 | 0 | 15 | 0 | 15 |
| EG016 | Cohort 5: 300 mg Carbamazepine (Days 8 to 10) | Participants received 300 mg carbamazepine administered orally BID (Days 8 to 10). | 0 | 15 | 0 | 15 | 2 | 15 |
| EG017 | Cohort 5: 300 mg Carbamazepine + 1.2 mg Midazolam (Day 11) | Participants received 300 mg carbamazepine BID + 1.2 mg midazolam (co-administered with morning dose) administered orally (Day 11) | 0 | 15 | 0 | 15 | 1 | 15 |
| EG018 | Cohort 5: 300 mg Carbamazepine (Days 12 to 13) | Participants received 300 mg carbamazepine administered orally BID (Days 12 to 13) | 0 | 15 | 0 | 15 | 2 | 15 |
| EG019 | Cohort 5: 300 mg Carbamazepine + 1.2 mg Midazolam (Day 14) | Participants received 300 mg carbamazepine BID + 1.2 mg midazolam (co-administered with morning dose) administered orally (Day 14). | 0 | 14 | 0 | 14 | 0 | 14 |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Pharyngeal hypoaesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.1 | 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 |
| D014230 | Triazoles |
| D001393 | Azoles |
| D010879 | Piperazines |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
|
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