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| ID | Type | Description | Link |
|---|---|---|---|
| J3D-MC-FNAA | Other Identifier | Eli Lilly and Company | |
| 2020-003957-30 | EudraCT Number |
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Terminated due to safety findings
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The main purpose of this study in healthy participants is to learn more about the safety of LY3509754 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3509754 gets into the bloodstream and how long it takes the body to eliminate it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3509754 - Part A | Experimental | Escalating doses of 10, 30, 100, 300, 1000, and 2000 milligrams (mg) of LY3509754 were administered orally. |
|
| Placebo - Part A | Placebo Comparator | Placebo was administered orally. |
|
| LY3509754 plus Itraconazole - Part B | Experimental | 10 mg of LY3509754 and 200 mg of Itraconazole were administered orally. |
|
| Placebo plus Itraconazole - Part B | Placebo Comparator | Placebo and 200 mg Itraconazole were administered orally. |
|
| LY3509754 plus Midazolam - Part C | Experimental | Multiple doses of LY3509754 (100, 300, and 1000 mg) were administered orally. Some participants also received 1.2 mg midazolam orally. |
|
| Placebo plus Midazolam - Part C |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3509754 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | An SAE is any adverse event (AE) from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module. | Baseline up to Day 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3509754 in Parts A and B | PK: Cmax of LY3509754 in Parts A and B. | Part A: Pre-dose (P), 0.5,1,2,3,4,5,6,8,12,16,24,36,48,72,96 hours (h) post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96,120,144,168 h Post Day 10 dose. |
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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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Covance Dallas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38294091 | Derived | Datta-Mannan A, Regev A, Coutant DE, Dropsey AJ, Foster J, Jones S, Poorbaugh J, Schmitz C, Wang E, Woodman ME. Safety, Tolerability, and Pharmacokinetics of an Oral Small Molecule Inhibitor of IL-17A (LY3509754): A Phase I Randomized Placebo-Controlled Study. Clin Pharmacol Ther. 2024 May;115(5):1152-1161. doi: 10.1002/cpt.3185. Epub 2024 Jan 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A - Placebo (Fasted) | Participants received single oral dose of placebo under fasting condition. |
| FG001 | Part A - Placebo (Fed) | Participants received single oral dose of placebo under fed condition. |
| FG002 | Part A - 10 Milligram (mg) LY3509754 (Fasted) | Participants received a single oral dose of 10 mg LY3509754 under fasting condition. |
| FG003 | Part A - 30 mg LY3509754 (Fasted) | Participants received a single oral dose of 30 mg LY3509754 under fasting condition. |
| FG004 | Part A - 100 mg LY3509754 (Fasted) | Participants received a single oral dose of 100 mg LY3509754 under fasting condition. |
| FG005 | Part A - 300 mg LY3509754 (Fasted and Fed) | Participants received a single oral dose of 300 mg LY3509754 under fasting condition. There was a washout period of at least 5 days. Participants received a single oral dose of 300 mg LY3509754 under fed condition. |
| FG006 | Part A - 1000 mg LY3509754 (Fasted) | Participants received a single oral dose of 1000 mg LY3509754 under fasting condition. |
| FG007 | Part A - 2000 mg LY3509754 (Fasted) | Participants received a single oral dose of 2000 mg LY3509754 under fasting condition. |
| FG008 | Part B - Placebo + 200 mg Itraconazole (Day 10) | Participants received a single oral dose of placebo on Day 1 followed by daily doses of 200 mg itraconazole as oral solution for 10 days twice daily (BID) on Day 4 and once daily (QD) from Days 5 through 13. Participants received a single oral dose of placebo on Day 10. |
| FG009 | Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10) | Participants received a single oral dose of 10 mg LY3509754 on Day 1 followed by daily doses of 200 mg itraconazole as oral solution for 10 days BID on Day 4 and QD from Days 5 through 13. Participants received a single oral dose of placebo on Day 10. |
| FG010 | Part C - QD [Cohorts 1 and 3] | Participants received oral doses of placebo QD for 14 Days. |
| FG011 | Part C - 100 mg LY3509754 QD [Cohort 1] | Participants received oral doses of 100 mg LY3509754 QD for 14 Days. |
| FG012 | Part C - Placebo QD + 1.2 mg Midazolam [Cohort 2] | Participants received a single dose of 1.2 mg midazolam given as oral solution on Day -2 followed by oral doses of placebo QD from Day 1 to 15. Participants then received a single dose of 1.2 mg midazolam given as oral solution on Day 15. |
| FG013 | Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam [Cohort 2] | Participants received a single dose of 1.2 mg midazolam given as oral solution on Day -2 followed by oral doses of 300 mg LY3509754 QD from Day 1 to 15. Participants then received a single dose of 1.2 mg midazolam given as oral solution on Day 15. |
| FG014 | Part C - 1000 mg LY3509754 QD [Cohort 3] | Participants received oral doses of 1000 mg LY3509754 QD for 14 Days. |
| FG015 | Part D (Japanese) - Placebo QD | Participants received oral doses of placebo QD for 14 Days. |
| FG016 | Part D (Japanese) - 400 mg LY3509754 QD | Participants received oral doses of 400 mg LY3509754 QD for 14 Days. |
| FG017 | Part D (Japanese) - 1000 mg LY3509754 QD | Participants received oral doses of 1000 mg LY3509754 QD for 14 Days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A - Placebo (Fasted) | Participants received single oral dose of placebo under fasting condition. |
| BG001 | Part A - Placebo (Fed) | Participants received single oral dose of placebo under fed condition. |
| 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 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | An SAE is any adverse event (AE) from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline up to Day 26 |
|
Baseline to Up To Day 26
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.
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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 | Part A - Placebo (Fasted) | Participants received single oral dose of placebo under fasting condition. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous detachment | Eye disorders | MedDRA 23.0 | Systematic Assessment |
Terminated [Terminated due to safety findings].
| 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 | Dec 1, 2021 | Oct 11, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2021 | Oct 11, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo Comparator |
Multiple doses of placebo were administered orally. Some participants also received 1.2 mg midazolam orally. |
|
| LY3509754 (Japanese) - Part D | Experimental | Multiple doses of LY3509754 (400 and 1000 mg) were administered orally to Japanese participants. |
|
| Placebo (Japanese) - Part D | Placebo Comparator | Placebo was administered orally to Japanese participants. |
|
| Placebo | Drug | Administered orally |
|
| Itraconazole | Drug | Administered orally |
|
| Midazolam | Drug | Administered orally |
|
| PK: Cmax of LY3509754 in Parts C and D | PK: Cmax of LY3509754 in Parts C and D. | Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose. |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Post-dose AUC(0-24) of LY3509754 in Parts A and B | PK: AUC(0-24) of LY3509754 in Parts A and B. | Part A: P, 0.5,1,2,3,4,5,6,8,12,16,24 h post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 10 dose. |
| PK: AUC(0-24) of LY3509754 in Parts C and D | PK: AUC(0-24) of LY3509754 in Parts C and D. | Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose. |
| Dallas |
| Texas |
| 75247 |
| United States |
| Withdrawal by Subject |
|
| BG002 | Part A - 10 mg LY3509754 (Fasted) | Participants received a single oral dose of 10 mg LY3509754 under fasting condition. |
| BG003 | Part A - 30 mg LY3509754 (Fasted) | Participants received a single oral dose of 30 mg LY3509754 under fasting condition. |
| BG004 | Part A - 100 mg LY3509754 (Fasted) | Participants received a single oral dose of 100 mg LY3509754 under fasting condition. |
| BG005 | Part A - 300 mg LY3509754 (Fasted and Fed) | Participants received a single oral dose of 300 mg LY3509754 under fasting condition. There was a washout period of at least 5 days. Participants received a single oral dose of 300 mg LY3509754 under fed condition. |
| BG006 | Part A - 1000 mg LY3509754 (Fasted) | Participants received a single oral dose of 1000 mg LY3509754 under fasting condition. |
| BG007 | Part A - 2000 mg LY3509754 (Fasted) | Participants received a single oral dose of 2000 mg LY3509754 under fasting condition. |
| BG008 | Part B - Placebo + 200 mg Itraconazole (Day 10) | Participants received a single oral dose of placebo on Day 1 followed by daily doses of 200 mg itraconazole as oral solution for 10 days BID on Day 4 and QD from Days 5 through 13. Participants received a single oral dose of placebo on Day 10. |
| BG009 | Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10) | Participants received a single oral dose of 10 mg LY3509754 on Day 1 followed by daily doses of 200 mg itraconazole as oral solution for 10 days BID on Day 4 and QD from Days 5 through 13. Participants received a single oral dose of placebo on Day 10. |
| BG010 | Part C - Placebo QD [Cohorts 1 and 3] | Participants received oral doses of placebo QD for 14 Days. |
| BG011 | Part C - 100 mg LY3509754 QD [Cohort 1] | Participants received oral doses of 100 mg LY3509754 QD for 14 Days. |
| BG012 | Part C - Placebo QD + 1.2 mg Midazolam [Cohort 2] | Participants received a single dose of 1.2 mg midazolam given as oral solution on Day -2 followed by oral doses of placebo QD from Day 1 to 15. Participants then received a single dose of 1.2 mg midazolam given as oral solution on Day 15. |
| BG013 | Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam [Cohort 2] | Participants received a single dose of 1.2 mg midazolam given as oral solution on Day -2 followed by oral doses of 300 mg LY3509754 QD from Day 1 to 15. Participants then received a single dose of 1.2 mg midazolam given as oral solution on Day 15. |
| BG014 | Part C - 1000 mg LY3509754 QD [Cohort 3] | Participants received oral doses of 1000 mg LY3509754 QD for 14 Days. |
| BG015 | Part D (Japanese) - Placebo QD | Participants received oral doses of placebo QD for 14 Days. |
| BG016 | Part D (Japanese) - 400 mg LY3509754 QD | Participants received oral doses of 400 mg LY3509754 QD for 14 Days. |
| BG017 | Part D (Japanese) - 1000 mg LY3509754 QD | Participants received oral doses of 1000 mg LY3509754 QD for 14 Days. |
| BG018 | 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 |
|
| OG000 |
| Part A - Placebo (Fasted) |
Participants received single oral dose of placebo under fasting condition. |
| OG001 | Part A - Placebo (Fed) | Participants received single oral dose of placebo under fed condition. |
| OG002 | Part A - 10 Milligram (mg) LY3509754 (Fasted) | Participants received a single oral dose of 10 mg LY3509754 under fasting condition. |
| OG003 | Part A - 30 mg LY3509754 (Fasted) | Participants received a single oral dose of 30 mg LY3509754 under fasting condition. |
| OG004 | Part A - 100 mg LY3509754 (Fasted) | Participants received a single oral dose of 100 mg LY3509754 under fasting condition. |
| OG005 | Part A - 300 mg LY3509754 (Fasted) | Participants received a single oral dose of 300 mg LY3509754 under fasting condition. |
| OG006 | Part A - 300 mg LY3509754 (Fed) | Participants received a single oral dose of 300 mg LY3509754 under fed condition. |
| OG007 | Part A - 1000 mg LY3509754 (Fasted) | Participants received a single oral dose of 1000 mg LY3509754 under fasting condition. |
| OG008 | Part A - 2000 mg LY3509754 (Fasted) | Participants received a single oral dose of 2000 mg LY3509754 under fasting condition. |
| OG009 | Part B - Placebo Alone (Day 1) | Participants received a single oral dose of placebo on Day 1. |
| OG010 | Part B - Placebo + 200 mg Itraconazole (Day 10) | Participants received a single oral dose of placebo and 200 mg itraconazole oral solution on Day 10. |
| OG011 | Part B - 200 mg Itraconazole (Days 4 to 13) | Participants received 200 mg itraconazole as an oral solution BID on Day 4 and QD on Days 5 through 13. |
| OG012 | Part B - 10 mg LY3509754 Alone (Day 1) | Participants received a single oral dose of 10 mg LY3509754 on Day 1. |
| OG013 | Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10) | Participants received a single oral dose of 10 mg LY3509754 and 200 mg itraconazole oral solution on Day 10. |
| OG014 | Part C - Placebo QD [Cohorts 1 and 3] | Participants received oral doses of placebo QD for 14 Days. |
| OG015 | Part C - 100 mg LY3509754 QD [Cohort 1] | Participants received oral doses of 100 mg LY3509754 QD for 14 Days. |
| OG016 | Part C - 1.2 mg Midazolam (Day -2) [Cohort 2] | Participants received 1.2 mg midazolam as an oral solution on Day -2. |
| OG017 | Part C - Placebo QD (Days 1 to 14) [Cohort 2] | Participants received oral doses of placebo QD for 14 Days upon receiving 1.2 mg midazolam on Day -2. |
| OG018 | Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2] | Participants received oral doses 300 mg of LY3509754 QD for 14 Days upon receiving 1.2 mg midazolam on Day -2. |
| OG019 | Part C - Placebo QD + 1.2 mg Midazolam (Day 15) [Cohort 2] | Participants received a single oral dose of placebo QD along with 1.2 mg midazolam given as oral solution on Day 15. |
| OG020 | Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam (Day 15) [Cohort 2] | Participants received a single oral dose of 300 mg LY3509754 QD along with 1.2 mg midazolam given as oral solution on Day 15. |
| OG021 | Part C - 1000 mg LY3509754 QD [Cohort 3] | Participants received oral doses of 1000 mg LY3509754 QD for 14 Days. |
| OG022 | Part D (Japanese) - Placebo QD | Participants received oral doses of placebo QD for 14 Days. |
| OG023 | Part D (Japanese) - 400 mg LY3509754 QD | Participants received oral doses of 400 mg LY3509754 QD for 14 Days. |
| OG024 | Part D (Japanese) - 1000 mg LY3509754 QD | Participants received oral doses of 1000 mg LY3509754 QD for 14 Days. |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3509754 in Parts A and B | PK: Cmax of LY3509754 in Parts A and B. | All participants who received at least one dose of LY3509754 or itraconazole and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Part A: Pre-dose (P), 0.5,1,2,3,4,5,6,8,12,16,24,36,48,72,96 hours (h) post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96,120,144,168 h Post Day 10 dose. |
|
|
|
| Secondary | PK: Cmax of LY3509754 in Parts C and D | PK: Cmax of LY3509754 in Parts C and D. | All participants who received at least one dose of LY3509754 or midazolam and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose. |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Post-dose AUC(0-24) of LY3509754 in Parts A and B | PK: AUC(0-24) of LY3509754 in Parts A and B. | All participants who received at least one dose of LY3509754 or itraconazole and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram *hour per milliliter (ng*h/mL) | Part A: P, 0.5,1,2,3,4,5,6,8,12,16,24 h post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 10 dose. |
|
|
|
| Secondary | PK: AUC(0-24) of LY3509754 in Parts C and D | PK: AUC(0-24) of LY3509754 in Parts C and D. | All participants who received at least one dose of LY3509754 or midazolam and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose. |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Part A - Placebo (Fed) | Participants received single oral dose of placebo under fed condition. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | Part A - 10 Milligram (mg) LY3509754 (Fasted) | Participants received a single oral dose of 10 mg LY3509754 under fasting condition. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Part A - 30 mg LY3509754 (Fasted) | Participants received a single oral dose of 30 mg LY3509754 under fasting condition. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | Part A - 100 mg LY3509754 (Fasted) | Participants received a single oral dose of 100 mg LY3509754 under fasting condition. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG005 | Part A - 300 mg LY3509754 (Fasted) | Participants received a single oral dose of 300 mg LY3509754 under fasting condition. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG006 | Part A - 300 mg LY3509754 (Fed) | Participants received a single oral dose of 300 mg LY3509754 under fed condition. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG007 | Part A - 1000 mg LY3509754 (Fasted) | Participants received a single oral dose of 1000 mg LY3509754 under fasting condition. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG008 | Part A - 2000 mg LY3509754 (Fasted) | Participants received a single oral dose of 2000 mg LY3509754 under fasting condition. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG009 | Part B - Placebo Alone (Day 1) | Participants received a single oral dose of placebo on Day 1. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG010 | Part B - Placebo + 200 mg Itraconazole (Day 10) | Participants received a single oral dose of placebo and 200 mg itraconazole oral solution on Day 10. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG011 | Part B - 200 mg Itraconazole (Days 4 to 13) | Participants received 200 mg itraconazole as an oral solution BID on Day 4 and QD on Days 5 through 13. | 0 | 11 | 0 | 11 | 4 | 11 |
| EG012 | Part B - 10 mg LY3509754 Alone (Day 1) | Participants received a single oral dose of 10 mg LY3509754 on Day 1. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG013 | Part B - 10 mg LY3509754 + 200 mg Itraconazole (Day 10) | Participants received a single oral dose of 10 mg LY3509754 and 200 mg itraconazole oral solution on Day 10. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG014 | Part C - Placebo QD [Cohorts 1 and 3] | Participants received oral doses of placebo QD for 14 Days. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG015 | Part C - 100 mg LY3509754 QD [Cohort 1] | Participants received oral doses of 100 mg LY3509754 QD for 14 Days. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG016 | Part C - 1.2 mg Midazolam (Day -2) [Cohort 2] | Participants received 1.2 mg midazolam as an oral solution on Day -2. | 0 | 10 | 0 | 10 | 1 | 10 |
| EG017 | Part C - Placebo QD (Days 1 to 14) [Cohort 2] | Participants received oral doses of placebo QD for 14 Days upon receiving 1.2 mg midazolam on Day -2. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG018 | Part C - 300 mg LY3509754 QD (Days 1 to 14) [Cohort 2] | Participants received oral doses of 300 mg LY3509754 QD for 14 Days upon receiving 1.2 mg midazolam on Day -2. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG019 | Part C - Placebo QD + 1.2 mg Midazolam (Day 15) [Cohort 2] | Participants received a single oral dose of placebo QD along with 1.2 mg midazolam given as oral solution on Day 15. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG020 | Part C - 300 mg LY3509754 QD + 1.2 mg Midazolam (Day 15) [Cohort 2] | Participants received a single oral dose of 300 mg LY3509754 QD along with 1.2 mg midazolam given as oral solution on Day 15. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG021 | Part C - 1000 mg LY3509754 QD [Cohort 3] | Participants received oral doses of 1000 mg LY3509754 QD for 14 Days. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG022 | Part D (Japanese) - Placebo QD | Participants received oral doses of placebo QD for 15 Days. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG023 | Part D (Japanese) - 400 mg LY3509754 QD | Participants received oral doses of 400 mg LY3509754 QD for 15 Days. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG024 | Part D (Japanese) - 1000 mg LY3509754 QD | Participants received oral doses of 1000 mg LY3509754 QD for 15 Days. | 0 | 6 | 0 | 6 | 4 | 6 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Saliva altered | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Medical device site irritation | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vessel puncture site haemorrhage | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Asymptomatic COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Asymptomatic bacteriuria | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Hepatitis e | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Gingival injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Mouth injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Influenza b virus test positive | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
Not provided
| D010879 |
| Piperazines |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |