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| ID | Type | Description | Link |
|---|---|---|---|
| J1X-MC-GZHF | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety and tolerability of LY3493269 in healthy participants. The blood tests will be performed to check how much LY3493269 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3493269. The study will last up to approximately 71 days for each participant, including screening
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received placebo orally once daily (QD) for three consecutive days. |
|
| 8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC) | Experimental | Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days. |
|
| 24 mg LY3493269 + 600 mg SNAC | Experimental | Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days. |
|
| 12 mg LY3493269 + 300 mg SNAC | Experimental | Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days. |
|
| 4 mg LY3493269 + 300 mg SNAC | Experimental | Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3493269 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) | TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. A summary of serious adverse events (SAEs), TEAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Adverse Events section of this record. | Baseline through Day 44 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC [0-24]) of LY3493269 | PK: AUC (0-24) of LY3493269 | Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose |
| PK: Maximum Concentration (Cmax) of LY3493269 |
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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 |
|---|---|---|---|---|---|---|
| Lilly Centre for Clinical Pharmacology | Singapore | 138623 | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo orally once daily (QD) for three consecutive days. |
| FG001 | 8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC) | Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days. |
| FG002 | 24 mg LY3493269 + 600 mg SNAC | Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days. |
| FG003 | 12 mg LY3493269 + 300 mg SNAC | Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days. |
| FG004 | 4 mg LY3493269 + 300 mg SNAC | Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days. |
| 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 | Participants received placebo orally QD for three consecutive days. |
| BG001 | 8 mg LY3493269 + 600 mg SNAC | Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days. |
| 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 Treatment-Emergent Adverse Event(s) (TEAEs) | TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. A summary of serious adverse events (SAEs), TEAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Adverse Events section of this record. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through Day 44 |
|
Baseline to 44 Days
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
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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 | Participants received placebo orally QD for three consecutive days. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 8005455979 | 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 5, 2021 | Nov 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2021 | Nov 27, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C111140 | N-(8-(2-hydroxybenzoyl)amino)caprylate |
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| Placebo | Drug | Administered orally. |
|
| Salcaprozate Sodium | Drug | Administered orally. |
|
PK: Cmax of LY3493269 |
| Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose |
| BG002 | 24 mg LY3493269 + 600 mg SNAC | Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days. |
| BG003 | 12 mg LY3493269 + 300 mg SNAC | Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days. |
| BG004 | 4 mg LY3493269 + 300 mg SNAC | Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days. |
| BG005 | 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 |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| 8 mg LY3493269 + 600 mg SNAC |
Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days. |
| OG002 | 24 mg LY3493269 + 600 mg SNAC | Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days. |
| OG003 | 12 mg LY3493269 + 300 mg SNAC | Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days. |
| OG004 | 4 mg LY3493269 + 300 mg SNAC | Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC [0-24]) of LY3493269 | PK: AUC (0-24) of LY3493269 | All enrolled participants who received at least one dose of LY3493269 and had at least one evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours per milliliter (ng*h/mL) | Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) of LY3493269 | PK: Cmax of LY3493269 | All enrolled participants who received at least one dose of LY3493269 and had at least one evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose |
|
|
|
| 8 |
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | 8 mg LY3493269 + 600 mg SNAC | Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG002 | 24 mg LY3493269 + 600 mg SNAC | Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG003 | 12 mg LY3493269 + 300 mg SNAC | Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG004 | 4 mg LY3493269 + 300 mg SNAC | Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days. | 0 | 8 | 0 | 8 | 6 | 8 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Lip dry | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Catheter site bruise | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Medical device site erythema | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Medical device site laceration | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Medical device site pruritus | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Swelling face | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Ulcer | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Catheter site infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Head discomfort | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Hyperaesthesia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Paraesthesia | 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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| Sleep disorder | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
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