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| ID | Type | Description | Link |
|---|---|---|---|
| J2G-MC-JZPA | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The main purpose of this study is to learn about how food affects selpercatinib in healthy participants. The selpercatinib will be administered in fed and fasted states. Participation could last about 7 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selpercatinib (Fasted/Fed) | Experimental | Period 1: 160 milligrams (mg) Selpercatinib administered orally on Day 1 in fasted state. Period 2: 160 mg Selpercatinib administered orally on Day 8 in fed state. |
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| Selpercatinib (Fed/Fasted) | Experimental | Period 1: 160 mg Selpercatinib administered orally on Day 1 in fed state. Period 2: 160 mg Selpercatinib administered orally on Day 8 in fasted state. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selpercatinib | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics(PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib | PK: AUC[0-∞] of Selpercatinib' | PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose; |
| PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib | PK: AUC[0-tlast] of Selpercatinib | PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose; |
| PK: Maximum Concentration (Cmax) of Selpercatinib | PK: Cmax of Selpercatinib. | PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) 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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| ID | Title | Description |
|---|---|---|
| FG000 | Selpercatinib Fasted/Fed | 160 milligrams (mg) Selpercatinib will be administered orally on Day 1 in fasted state and on Day 8 in fed state. |
| FG001 | Selpercatinib Fed/Fasted | 160 mg Selpercatinib will be administered orally on Day 1 in fed state and on Day 8 in fasted state. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Selpercatinib | 160 mg Selpercatinib will be administered orally on Day 1 in fasted state or fed state and on Day 8 in fed state or fasted state. |
| 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 Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib | PK: AUC[0-∞] of Selpercatinib' | All participants who received doses of study drug on Day 1 and Day 8 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram * hour per milliliter (ng*hr/mL | PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose; |
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Screening up to 21 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 | 160 mg Selpercatinib Fasted | 160 milligrams (mg) Selpercatinib will be administered orally on Day 1 in fasted state and on Day 8 in fed state. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-595-5979 | 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 | Nov 22, 2021 | Sep 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2022 | Sep 25, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000656166 | selpercatinib |
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| NOT COMPLETED |
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| years |
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| 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 |
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| Primary | PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Selpercatinib | PK: AUC[0-tlast] of Selpercatinib | All participants who received doses of study drug on Day 1 and Day 8 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose; |
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| Primary | PK: Maximum Concentration (Cmax) of Selpercatinib | PK: Cmax of Selpercatinib. | All participants who received doses of study drug on Day 1 and Day 8 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | PK: Day 1 and Day 8: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours (h) postdose; |
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| 0 |
| 45 |
| 0 |
| 45 |
| 29 |
| 45 |
| EG001 | 160 mg Selpercatinib Fed | 160 mg Selpercatinib will be administered orally on Day 1 in fed state and on Day 8 in fasted state. | 0 | 45 | 0 | 45 | 21 | 45 |
| Catheter site bruise | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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