Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J1X-MC-GZHI | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Following preplanned review of the safety and pharmacokinetic data from Part A, it was determined that sufficient data had been obtained. The decision was made to not proceed with Part B and the study was terminated early.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to conduct blood tests to measure how much LY3493269 is in the bloodstream and how the body handles and eliminates LY3493269 when administered orally as test compared to reference formulations in healthy participants in fed and/or fasted states. The study will also evaluate the safety and tolerability of LY3493269 in these participants. The study will last up to 43 days excluding the screening period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted) | Experimental |
|
|
| Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted) | Experimental |
|
|
| Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted) | Experimental |
|
|
| Part B: LY3493269 | Experimental | The formulation of the LY3493269 test capsule (1,2) or reference tablet were planned to be determined based on the initial review of safety and pharmacokinetic data from Part A. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3493269 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3493269 | PK: AUC (0-∞) of LY3493269 | Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48, 72,120, 288, 624 and 960 hours (h) post-dose |
| Part A: PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUCÏ„) of LY3493269 | PK: AUCÏ„ of LY3493269 | Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14 and 24 hours (h) post-dose |
| Part A: PK: Maximum Observed Drug Concentration (Cmax) of LY3493269 | Cmax of LY3493269 | Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 12, 14 and 24 hours (h) post-dose |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
The study was planned to be conducted in two parts (Part A and Part B) -
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted) |
|
| FG001 | Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted) |
|
| FG002 | Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted) |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted) |
|
| BG001 |
| 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 | Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3493269 | PK: AUC (0-∞) 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, 9, 10, 12, 14, 24, 48, 72,120, 288, 624 and 960 hours (h) post-dose |
|
Part A: Baseline to end of follow-up (up to 43 days)
All enrolled participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.
Not provided
| 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: 4 mg LY3493269 Test Capsule 1 + 280 mg C10 (Fasted) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment | The adverse event was deemed by the investigator as not related to study treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
The study was terminated early, and Part B was not executed, as sufficient safety and pharmacokinetic data had already been obtained from Part A.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 18, 2022 | Sep 21, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 5, 2023 | Sep 21, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C031071 | decanoic acid |
| D015260 | Neprilysin |
| C111140 | N-(8-(2-hydroxybenzoyl)amino)caprylate |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sodium Caprate (C10) | Drug | Administered orally. |
|
| Salcaprozate Sodium (SNAC) | Drug | Administered orally. |
|
| Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted) |
|
| BG002 | Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted) |
|
| BG003 | 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 |
|
| Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted) |
|
| OG002 | Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted) |
|
|
|
|
| Primary | Part A: PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUCÏ„) of LY3493269 | PK: AUCÏ„ 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, 9, 10, 12, 14 and 24 hours (h) post-dose |
|
|
|
| Primary | Part A: PK: Maximum Observed Drug Concentration (Cmax) of LY3493269 | 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, 9, 10, 12, 14 and 24 hours (h) post-dose |
|
|
|
|
| 0 |
| 11 |
| 1 |
| 11 |
| 9 |
| 11 |
| EG001 | Part A: 4 mg LY3493269 Test Capsule 2 + 280 mg C10 (Fasted) |
| 0 | 15 | 0 | 15 | 11 | 15 |
| EG002 | Part A: 4 mg LY3493269 Reference Tablet + 300 mg SNAC (Fasted) |
| 0 | 14 | 0 | 14 | 11 | 14 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Catheter site bruise | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Catheter site phlebitis | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Early satiety | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hunger | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Medical device site erythema | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Medical device site reaction | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vessel puncture site erythema | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D014408 | Biomarkers, Tumor |
| D015415 | Biomarkers |
Cmax was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs. |
| Mixed Models Analysis |
| Ratio of Geometric Least Squares Means |
| 0.343 |
| 2-Sided |
| 90 |
| 0.206 |
| 0.569 |
| Other |