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| ID | Type | Description | Link |
|---|---|---|---|
| J2M-MC-GZKA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study in healthy participants is to learn more about the safety of LY3478045 and any side effects that might be associated with it. The study will also measure how much LY3478045 gets into the bloodstream and how long it takes the body to get rid of it.
This study has two parts: Part A (one dose) will last about six weeks and Part B (more than one dose) will last about eight weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3478045 (Part A) | Experimental | Participants received single ascending oral dose of 20 milligram (mg), 60mg, 180 mg, 500 mg, 700 mg LY3478045 on Day 1. |
|
| Placebo (Part A) | Placebo Comparator | Participants received single oral dose of placebo on Day 1. |
|
| LY3478045 (Part B) | Experimental | Participants received multiple ascending oral dose of 60mg and 300 mg LY3478045 once-daily (QD)for 14 days. |
|
| Placebo (Part B) | Placebo Comparator | Participants received oral dose of placebo QD for 14 days. |
|
| LY3478045 + Atorvastatin (Part B) | Experimental | Participants received multiple ascending oral doses of 160 mg, 360 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. |
|
| Placebo + Atorvastatin (Part B) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3478045 | 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 | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is reported in the Reported Adverse Events module. | Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3478045 | PK: AUC(0-inf) of LY3478045 was reported. | Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post 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 |
|---|---|---|---|---|---|---|
| Covance Dallas | Dallas | Texas | 75247 | United States |
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The study included two parts (Part A and Part B). A single ascending oral dose of LY3478045 was administered in Part A, and multiple ascending oral doses of LY3478045 were administered once daily (QD) in Part B. Participants in a few reporting arms of Part B received a 40-milligram (mg) oral dose of atorvastatin 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Part A) | Participants received single oral dose of placebo on Day 1. |
| FG001 | 20 mg LY3478045 (Part A) | Participants received single oral dose of 20 mg LY3478045 on Day 1. |
| FG002 | 60 mg LY3478045 (Part A) | Participants received single oral dose of 60 mg LY3478045 on Day 1. |
| FG003 | 180 mg LY3478045 (Part A) | Participants received single oral dose of 180 mg LY3478045 on Day 1. |
| FG004 | 500 mg LY3478045 (Part A) | Participants received single oral dose of 500 mg LY3478045 on Day 1. |
| FG005 | 700 mg LY3478045 (Part A) | Participants received single oral dose of 700 mg LY3478045 on Day 1. |
| FG006 | Placebo Once-daily (QD) (Part B) | Participants received oral dose of Placebo QD for 14 days. |
| FG007 | Placebo QD + 40 mg Atorvastatin (Part B) | Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. |
| FG008 | 60 mg LY3478045 QD (Part B) | Participants received oral dose of 60 mg LY3478045 QD for 14 days. |
| FG009 | 160 mg LY3478045 QD + 40 mg Atorvastatin (Part B) | Participants received oral dose of 160 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. |
| FG010 | 300 mg LY3478045 QD (Part B) | Participants received oral dose of 300 mg LY3478045 QD for 14 days. |
| FG011 | 360 mg LY3478045 QD + 40 mg Atorvastatin (Part B) | Participants received oral dose of 360 mg LY3478045 for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Part A) | Participants received single oral dose of placebo on Day 1. |
| BG001 | 20 mg LY3478045 (Part A) | Participants received single oral dose of 20 mg LY3478045 on Day 1. |
| 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 | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is reported in the Reported Adverse Events module. | All enrolled participants who received at least one dose of study drug. | Posted | Number | participants | Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B) |
|
Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
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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 | Placebo (Part A) | Participants received single oral dose of placebo on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 22.1 | 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 | Aug 11, 2021 | Feb 13, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2021 | Feb 13, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo Comparator |
Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. |
|
| Placebo | Drug | Administered orally. |
|
| Atorvastatin | Drug | Administered orally. |
|
| PK: Maximum Concentration (Cmax) of LY3478045 | PK: Cmax of LY3478045 was reported. | Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose |
| BG002 | 60 mg LY3478045 (Part A) | Participants received single oral dose of 60 mg LY3478045 on Day 1. |
| BG003 | 180 mg LY3478045 (Part A) | Participants received single oral dose of 180 mg LY3478045 on Day 1. |
| BG004 | 500 mg LY3478045 (Part A) | Participants received single oral dose of 500 mg LY3478045 on Day 1. |
| BG005 | 700 mg LY3478045 (Part A) | Participants received single oral dose of 700 mg LY3478045 on Day 1. |
| BG006 | Placebo QD (Part B) | Participants received oral dose of placebo QD for 14 days. |
| BG007 | Placebo QD + 40 mg Atorvastatin (Part B) | Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. |
| BG008 | 60 mg LY3478045 QD (Part B) | Participants received oral dose of 60 mg LY3478045 QD for 14 days. |
| BG009 | 160 mg LY3478045 QD + 40 mg Atorvastatin (Part B) | Participants received oral dose of 160 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. |
| BG010 | 300 mg LY3478045 QD (Part B) | Participants received oral dose of 300 mg LY3478045 QD for 14 days. |
| BG011 | 360 mg LY3478045 QD + 40 mg Atorvastatin (Part B) | Participants received oral dose of 360 mg LY3478045 for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. |
| BG012 | 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 |
|
| OG002 | 60 mg LY3478045 (Part A) | Participants received single oral dose of 60 mg LY3478045 on Day 1. |
| OG003 | 180 mg LY3478045 (Part A) | Participants received single oral dose of 180 mg LY3478045 on Day 1. |
| OG004 | 500 mg LY3478045 (Part A) | Participants received single oral dose of 500 mg LY3478045 on Day 1. |
| OG005 | 700 mg LY3478045 (Part A) | Participants received single oral dose of 700 mg LY3478045 on Day 1. |
| OG006 | Placebo QD (Part B) | Participants received oral dose of placebo QD for 14 days. |
| OG007 | Placebo QD + 40 mg Atorvastatin (Part B) | Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. |
| OG008 | 60 mg LY3478045 QD (Part B) | Participants received oral dose of 60 mg LY3478045 QD for 14 days. |
| OG009 | 160 mg LY3478045 QD + 40 mg Atorvastatin (Part B) | Participants received oral dose of 160 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. |
| OG010 | 300 mg LY3478045 QD (Part B) | Participants received oral dose of 300 mg LY3478045 QD for 14 days. |
| OG011 | 360 mg LY3478045 QD + 40 mg Atorvastatin (Part B) | Participants received oral dose of 360 mg LY3478045 for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3478045 | PK: AUC(0-inf) of LY3478045 was reported. | All participants 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*h/ mL) | Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) of LY3478045 | PK: Cmax of LY3478045 was reported. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | 20 mg LY3478045 (Part A) | Participants received single oral dose of 20 mg LY3478045 on Day 1. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | 60 mg LY3478045 (Part A) | Participants received single oral dose of 60 mg LY3478045 on Day 1. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | 180 mg LY3478045 (Part A) | Participants received single oral dose of 180 mg LY3478045 on Day 1. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | 500 mg LY3478045 (Part A) | Participants received single oral dose of 500 mg LY3478045 on Day 1. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG005 | 700 mg LY3478045 (Part A) | Participants received single oral dose of 700 mg LY3478045 on Day 1. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG006 | Placebo QD (Part B) | Participants received oral dose of placebo QD for 14 days. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG007 | Placebo QD + 40 mg Atorvastatin (Part B) | Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG008 | 60 mg LY3478045 QD (Part B) | Participants received oral dose of 60 mg LY3478045 QD for 14 days. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG009 | 160 mg LY3478045 QD + 40 mg Atorvastatin (Part B) | Participants received oral dose of 160 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG010 | 300 mg LY3478045 QD (Part B) | Participants received oral dose of 300 mg LY3478045 QD for 14 days. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG011 | 360 mg LY3478045 QD + 40 mg Atorvastatin (Part B) | Participants received oral dose of 360 mg LY3478045 for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. | 0 | 6 | 1 | 6 | 1 | 6 |
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oral dysaesthesia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Medical device site irritation | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
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| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |