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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004290-46 | EudraCT Number | ||
| J2D-MC-CVAC | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to learn more about how the drug is absorbed in to the blood stream and how it is eliminated from the body. The safety and tolerability of LY3526318 will also be evaluated when given by mouth either by single or multiple doses to healthy participants. The study will have two parts. Each participant will enroll in only one part. For each participant, Part A will last up to 44 days and Part B will last up to 50 days, including screening and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3526318 (Part A) | Experimental | 250 mg, 100 milligram (mg) LY3526318 administered orally as single ascending doses under fasted or fed condition. |
|
| LY3526318 (Part B) | Experimental | 250 mg LY3526318 administered orally as multiple doses under fasted or fed condition. |
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| Placebo (Part A) | Placebo Comparator | Placebo administered orally under fasted or fed condition. |
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| Placebo (Part B) | Placebo Comparator | Placebo administered orally under fasted or fed condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3526318 | Drug | Administered orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part A - SAD, Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318 | Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318 | Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose |
| Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 | Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 | Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose |
| Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau ]) of LY3526318 | Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau ]) of LY3526318 | Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose |
| Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 | Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 | Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Part A, SAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. |
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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 |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | 9728 | Netherlands |
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This study consists of 2 parts:
Both parts were randomized, double-blind, and placebo-controlled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A SAD: P1-L2-L3-L4 | P1: Participants received placebo administered orally under fasted condition during period 1. L2: Participants received 250 milligram (mg) LY3526318 administered orally under fasted condition during period 2. L3: Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast during period 3. L4: Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast during period 4. |
| FG001 | Part A SAD: L1-P1-L3-L4 | L1: Participants received 100 mg LY3526318 administered orally under fasted condition during period 1. P1: Participants received placebo administered orally under fasted condition during period 2. L3: Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast during period 3. L4: Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast during period 4. |
| FG002 | Part A SAD: L1-L2-P3-L4 | L1: Participants received 100 mg LY3526318 administered orally under fasted condition during period 1. L2: Participants received 250 mg LY3526318 administered orally under fasted conditions during period 2. P3: Participants received placebo administered orally in fed state after a light breakfast during period 3. L4: Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast during period 4. |
| FG003 | Part A SAD: L1-L2-L3-P4 | L1: Participants received 100 mg LY3526318 administered orally under fasted condition during period 1. L2: Participants received 250 mg LY3526318 administered orally under fasted condition during period 2. L3: Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast during period 3. P4: Participants received placebo administered orally in fed state after a high-fat breakfast during period 4. |
| FG004 | Part B MAD: Placebo | Participants received placebo administered orally under fasted conditions on Day 1 and Day 5 and in fed state after participants ate a standard breakfast without respect to dosing time on Day 2 to Day 4. |
| FG005 | Part B MAD: 250 mg LY3526318 | Participants received 250 mg LY3526318 administered orally under fasted conditions on Day 1 and Day 5 and in fed state after participants ate a standard breakfast without respect to dosing time on Day 2 to Day 4. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A SAD: Sequence P1-L2-L3-L4 | P1: Participants received placebo administered orally under fasted condition during period 1. L2: Participants received 250 mg LY3526318 administered orally under fasted condition during period 2. L3: Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast during period 3. L4: Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast during period 4. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Part A - SAD, Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318 | Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318 | Part A - SAD: All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours per milliliter (ng*h/mL) | Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose |
|
Baseline Up To 14 Days
All randomized 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 | Part A - SAD: Placebo Fed (Light Breakfast) | Participants received placebo administered orally in fed state after a light breakfast. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | 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 | Mar 11, 2021 | Apr 13, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2021 | Apr 13, 2022 | SAP_001.pdf |
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| Placebo |
| Drug |
Administered orally. |
|
| Single oral dose to up to 11 days of follow-up |
| Part B, MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. | Up to 14 days following first dose |
| Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Maximum Concentration (Cmax) | Part A, Effect of a meal on pharmacokinetics of LY3526318: Maximum Concentration (Cmax) | Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose |
| Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) | Part A, Effect of a meal on pharmacokinetics of LY3526318: Area under the concentration time curve from time 0 to infinity (AUC 0-∞) | Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose |
| Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax) | Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax) | Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Part A SAD: L1-P1-L3-L4 | L1: Participants received 100 mg LY3526318 administered orally under fasted condition during period 1. P1: Participants received placebo administered orally under fasted condition during period 2. L3: Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast during period 3. L4: Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast during period 4. |
| BG002 | Part A SAD: L1-L2-P3-L4 | L1: Participants received 100 mg LY3526318 administered orally under fasted condition during period 1. L2: Participants received 250 mg LY3526318 administered orally under fasted conditions during period 2. P3: Participants received placebo administered orally in fed state after a light breakfast during period 3. L4: Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast during period 4. |
| BG003 | Part A: L1-L2-L3-P4 | L1: Participants received 100 mg LY3526318 administered orally under fasted condition during period 1 L2: Participants received 250 mg LY3526318 administered orally under fasted condition during period 2. L3: Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast during period 3. P4: Participants received placebo administered orally in fed state after a high-fat breakfast during period 4. |
| BG004 | Part B MAD: Placebo | Participants received placebo administered orally under fasted conditions on Day 1 and Day 5 and in fed state after participants ate a standard breakfast without respect to dosing time on Day 2 to Day 4 |
| BG005 | Part B MAD: 250 mg LY3526318 | Participants received 250 mg LY3526318 administered orally under fasted conditions on Day 1 and Day 5 and in fed state after participants ate a standard breakfast without respect to dosing time on Day 2 to Day 4. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
|
Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast. |
| OG002 | Part A - SAD: 250 mg LY3526318 Fasted | Participants received 250 mg LY3526318 administered orally under fasted condition. |
| OG003 | Part A - SAD: 100 mg LY3526318 Fasted | Participants received 100 mg LY3526318 administered orally under fasted condition. |
|
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| Primary | Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 | Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 | Part A - SAD: 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) | Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose |
|
|
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| Primary | Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau ]) of LY3526318 | Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau ]) of LY3526318 | Part B - MAD: All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose |
|
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| Primary | Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 | Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 | Part B - MAD: 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) | Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose |
|
|
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| Secondary | Part A, SAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. | Part A, SAD: All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Single oral dose to up to 11 days of follow-up |
|
|
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| Secondary | Part B, MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. | Part B, MAD: All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Up to 14 days following first dose |
|
|
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| Secondary | Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Maximum Concentration (Cmax) | Part A, Effect of a meal on pharmacokinetics of LY3526318: Maximum Concentration (Cmax) | Part A, SAD: All participants who received 250 mg LY3526318 and had evaluable PK data. | Posted | Number | 90% Confidence Interval | unitless | Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose |
|
|
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| Secondary | Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) | Part A, Effect of a meal on pharmacokinetics of LY3526318: Area under the concentration time curve from time 0 to infinity (AUC 0-∞) | Part A, SAD: All participants who received 250 mg LY3526318 and had evaluable PK data. | Posted | Number | 90% Confidence Interval | unitless | Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose |
|
|
|
| Secondary | Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax) | Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax) | Part A, SAD: All participants who received 250 mg LY3526318 and had evaluable PK data | Posted | Number | 90% Confidence Interval | hours | Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | Part A - SAD: Placebo Fed (High Fat Meal) | Participants received placebo administered orally in fed state after a high-fat breakfast. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | Part A - SAD: Placebo Fasted | Participants received placebo administered orally under fasted condition. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG003 | Part A - SAD: 250 mg LY3526318 Fed (Light Breakfast) | Participants received 250 mg LY3526318 administered orally in fed state after a light breakfast. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG004 | Part A - SAD: 250 mg LY3526318 Fed (High Fat Meal) | Participants received 250 mg LY3526318 administered orally in fed state after a high-fat breakfast. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG005 | Part A - SAD: 250 mg LY3526318 Fasted | Participants received 250 mg LY3526318 administered orally under fasted condition. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG006 | Part A - SAD: 100 mg LY3526318 Fasted | Participants received 100 mg LY3526318 administered orally under fasted condition. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG007 | Part B MAD: Placebo | Participants received placebo administered orally under fasted conditions on Day 1 and Day 5 and in fed state after participants ate a standard breakfast without respect to dosing time on Day 2 to Day 4. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG008 | Part B MAD:250 mg LY3526318 | Participants received 250 mg LY3526318 administered orally under fasted conditions on Day 1 and Day 5 and in fed state after participants ate a standard breakfast without respect to dosing time on Day 2 to Day 4. | 0 | 6 | 0 | 6 | 4 | 6 |
| Toothache | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Catheter site haematoma | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Catheter site related reaction | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| SAEs |
|