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| ID | Type | Description | Link |
|---|---|---|---|
| J1X-MC-GZHB | 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 LY3493269 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3493269 gets into the bloodstream and how long it takes the body to eliminate it. For each participant, the study will last about 10 weeks and may include 12 visits, including five nights in a row in the clinical research center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3493269 | Experimental | 8, 24 or 48 milligrams (mg) LY3493269 + 250 or 500 mg permeation enhancer sodium caprate(C10) Once daily (QD) administered orally over 3 consecutive study days. |
|
| Placebo | Placebo Comparator | Placebo administered orally over 3 consecutive study days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3493269 | Drug | Administered orally. |
| |
| Placebo |
| 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 an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | Baseline through Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3493269 From Day 1 and Day 3 Doses | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3493269. Note:
|
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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 once daily (QD) administered orally over 3 consecutive study days. |
| FG001 | Cohort 1: 8 Milligrams (mg) LY3493269 + 500 mg C10 | Participants received 8 mg LY3493269 + 500 mg permeation enhancer sodium caprate(C10) QD administered orally over 3 consecutive study days. |
| FG002 | Cohort 2: 24 mg LY3493269 + 500 mg C10 | Participants received 24 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days. |
| FG003 | Cohort 3: 48 mg LY3493269 + 500 mg C10 | Participants received 48 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days. |
| FG004 | Cohort 4: 24 mg LY3493269 + 250 mg C10 | Participants received 24 mg LY3493269 + 250 mg C10 QD administered orally over 3 consecutive study days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo once daily (QD) administered orally over 3 consecutive study days. |
| BG001 | Cohort 1: 8 mg LY3493269 + 500 mg C10 | Participants received 8 milligrams (mg) LY3493269 + 500 mg permeation enhancer sodium caprate(C10) QD administered orally over 3 consecutive study 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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through Day 43 |
|
Baseline Up To 43 Days
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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 once daily (QD) administered orally over 3 consecutive study days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye 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 | Jul 22, 2020 | Sep 16, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2021 | Sep 16, 2021 | SAP_001.pdf |
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| Drug |
Administered orally. |
|
| Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 2. 6, 8, 12 and Day 2 predose; Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hours post dose, Day 4, pre-dose |
| PK: Area Under the Concentration Versus Time Curve From Zero to 24 (AUC[0-24]) of LY3493269 From Day 1 and Day 3 Doses | PK: Area Under the Concentration Versus Time Curve From Zero to 24 (AUC[0-24]) of LY3493269 From Day 1 and Day 3 Doses Note:
| Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and Day 2 predose; Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hours post dose, Day 4, pre-dose |
| Withdrawal by Subject |
|
| BG002 | Cohort 2: 24 mg LY3493269 + 500 mg C10 | Participants received 24 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days. |
| BG003 | Cohort 3: 48 mg LY3493269 + 500 mg C10 | Participants received 48 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days. |
| BG004 | Cohort 4: 24 mg LY3493269 + 250 mg C10 | Participants received 24 mg LY3493269 + 250 mg C10 QD administered orally over 3 consecutive study 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 |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 |
| 8 mg LY3493269 + 500 mg C10 |
Participants received 8 milligrams (mg) LY3493269 + 500 mg permeation enhancer sodium caprate(C10) QD administered orally over 3 consecutive study days. |
| OG002 | 24 mg LY3493269 + 500 mg C10 | Participants received 24 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days. |
| OG003 | 48 mg LY3493269 + 500 mg C10 | Participants received 48 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days. |
| OG004 | 24 mg LY3493269 + 250 mg C10 | Participants received 24 mg LY3493269 + 250 mg C10 QD administered orally over 3 consecutive study days. |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3493269 From Day 1 and Day 3 Doses | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3493269. Note:
| All randomized participants received at least 1 full dose of LY3493269 and had evaluable PK sample. Participants may have been excluded from the PK summary statistics and statistical analysis if they had an adverse event of vomiting that occurred at or before 2 times median time to maximum observed drug Concentration (tmax) | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter (ng/mL) | Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 2. 6, 8, 12 and Day 2 predose; Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hours post dose, Day 4, pre-dose |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve From Zero to 24 (AUC[0-24]) of LY3493269 From Day 1 and Day 3 Doses | PK: Area Under the Concentration Versus Time Curve From Zero to 24 (AUC[0-24]) of LY3493269 From Day 1 and Day 3 Doses Note:
| All randomized participants received at least 1 full dose of LY3493269 and had evaluable PK sample. Participants may have been excluded from the PK summary statistics and statistical analysis if they had an adverse event of vomiting that occurred at or before 2 times median time to maximum observed drug Concentration (tmax). | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms hour per milliliter (ng*h/mL) | Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and Day 2 predose; Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hours post dose, Day 4, pre-dose |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 7 |
| 8 |
| EG001 | 8 mg LY3493269 + 500 mg C10 | Participants received 8 milligrams (mg) LY3493269 + 500 mg permeation enhancer sodium caprate(C10) QD administered orally over 3 consecutive study days. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG002 | 24 mg LY3493269 + 500 mg C10 | Participants received 24 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG003 | 48 mg LY3493269 + 500 mg C10 | Participants received 48 mg LY3493269 + 500 mg C10 QD administered orally over 3 consecutive study days. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG004 | 24 mg LY3493269 + 250 mg C10 | Participants received 24 mg LY3493269 + 250 mg C10 QD administered orally over 3 consecutive study days. | 0 | 8 | 0 | 8 | 8 | 8 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal tenderness | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Epigastric discomfort | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Application site pruritus | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Catheter site bruise | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Catheter site erythema | 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 phlebitis | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Catheter site pruritus | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Medical device site erythema | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Medical device site injury | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Medical device site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Medical device site pruritus | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Medical device site reaction | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Pyrexia | 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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| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Poor quality sleep | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal 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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| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Day 3 |
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| Day 3 |
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