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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZGL | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with cyclosporine in healthy participants. The study will also evaluate the safety and tolerability of LY3502970 in healthy participants. This study will last up to approximately 76 days for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam + LY3502970 | Experimental | Period 1: 200 micrograms (μg) midazolam administered as oral solution (5mg/5 mL solution ampoule) on Day -1 followed by 3 milligrams (mg) LY3502970 capsule given orally on Day 1. |
|
| Cyclosporine + Midazolam + LY3502970 | Experimental | Period 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970 | PK: AUC of LY3502970 | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose |
| PK: Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970 | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose |
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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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This is a 2-period single arm study with a washout period of at least 14 days between Period 1 and Period 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Midazolam + Cyclosporine + LY3502970 | Period 1: 200 μg Midazolam administered as oral solution (5mg/5 mL solution ampoule) on Days -1, followed by 3 mg LY3502970 capsule given orally on Day 1. Period 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Midazolam + LY3502970 (Period 1) |
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| Cyclosporine + LY3502970 (Period 2) |
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All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Midazolam + Cyclosporine + LY3502970 | Period 1: 200 μg Midazolam administered as oral solution (5mg/5 mL solution ampoule) on Days -1, 16, 19 followed by 3 mg LY3502970 capsule given orally on Day 1. Period 2: 2 -100 mg Cyclosporine capsules administered twice daily (BID) on Days 15 through 19; 3 mg LY3502970 given orally on Day 17; 200 μg Midazolam administered as oral solution on Days 16 and 19; Single oral dose 200 mg cyclosporine on Day 20. |
| 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 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970 | PK: AUC of LY3502970 | 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*hr/mL | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose |
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Baseline up to 76 days
All 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 | 200 ug Midazolam | 200 ug midazolam administered as oral solution [5 milligrams (mg) per milliliter (mL) solution ampoule] on -1 Day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 8005955979 | 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 | Sep 13, 2022 | Nov 20, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 4, 2023 | Nov 20, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| C000729680 | orforglipron |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| LY3502970 | Drug | Administered orally. |
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| Cyclosporine | Drug | Administered orally. |
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| years |
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| Sex: Female, Male | 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 |
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| Primary | PK: Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970 | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96 hours postdose |
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| 0 |
| 31 |
| 0 |
| 31 |
| 4 |
| 31 |
| EG001 | 3 mg LY3502970 (Reference) | 3 mg LY3502970 capsule given orally on Day 1 in Period 1. | 0 | 31 | 0 | 31 | 28 | 31 |
| EG002 | 200 mg Cyclosporine BID + 200 ug Midazolam | 200 mg (2 - 100 mg) cyclosporine capsules administered twice daily (BID) on Days 15 through 19 in combination with 200 µg midazolam administered as oral solution on Days 16 and 19 | 0 | 24 | 0 | 24 | 18 | 24 |
| EG003 | 200 mg Cyclosporine BID + 3 mg LY3502970 (Test) | 200 mg (2 - 100 mg) cyclosporine capsules administered twice daily (BID) on Days 15 through 19 in combination with 3 mg LY3502970 on Day 17. | 0 | 24 | 0 | 24 | 22 | 24 |
| EG004 | 200 mg Cyclosporine | Single oral dose 200 mg (2 - 100 mg) cyclosporine capsules on Day 20. | 0 | 25 | 0 | 25 | 20 | 25 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Catheter site bruise | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Catheter site phlebitis | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Catheter site pruritus | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
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| D006571 | Heterocyclic Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |