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| ID | Type | Description | Link |
|---|---|---|---|
| J2G-MC-JZJZ | 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 compare the amount of selpercatinib that gets into the blood stream and how long it takes the body to get rid of it, when given as different formulations. The information about any adverse effects experienced will be collected and the tolerability of selpercatinib will also be evaluated. The study may last up to 56 days including the 28 days of screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selpercatinib (Test) | Experimental | 160 mg Selpercatinib (tablet formulation) given orally on days 1 and 15. |
|
| Selpercatinib (Reference) | Active Comparator | 160 mg Selpercatinib (2 X 80 mg capsule formulation) given orally on days 1 and 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selpercatinib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib | PK: Cmax of Selpercatinib | Day 1 and Day 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 312 hours (h) postdose; |
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Selpercatinib | PK: AUC[0-∞] of Selpercatinib. | Day 1 and Day 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 312 hours (h) postdose; |
| 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 | Day 1 and Day 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 312 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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| LabCorp CRU, Inc. |
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This study included a washout period of 14 days between doses of selpercatinib.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 - Selpercatinib Reference/Test | Sequence 1: 160 mg selpercatinib (2 x 80 mg capsules) in Period 1, 160 mg selpercatinib (1 x 160 mg tablet) in Period 2. |
| FG001 | Sequence 2 - Selpercatinib Test/Reference | Sequence 2: 160 mg selpercatinib (1 x 160 mg tablet) in Period 1, 160 mg Selpercatinib (2 x 80 mg capsules) in Period 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout Period |
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| Period 2 |
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All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 - Selpercatinib Reference/Test | Sequence 1: 160 mg selpercatinib (2 x 80 mg capsules) Reference/160 mg selpercatinib (1 x 160 mg tablet) Test |
| BG001 | Sequence 2: Selpercatinib Test/Reference |
| 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 | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib | PK: Cmax of Selpercatinib | All participants who received at least 1 dose of Selpercatinib and have evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Day 1 and Day 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 312 hours (h) postdose; |
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Baseline up to 28 days
All enrolled participants who received at least one dose of selpercatinib, whether or not they completed all protocol requirements, and have at least one postdose safety assessment.
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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 (2 x 80 mg Reference) | 160 mg selpercatinib (2 x 80 mg capsules) will be administered orally on Day 1 and Day 15. |
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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 | Oct 14, 2021 | Sep 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 20, 2021 | Sep 25, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000656166 | selpercatinib |
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| Daytona Beach |
| Florida |
| 32117 |
| United States |
| Covance Dallas | Dallas | Texas | 75247 | United States |
| LabCorp CRU, Inc. | Madison | Wisconsin | 53704 | United States |
| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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Sequence 2: 160 mg selpercatinib (1 x 160 mg tablet) Test/160 mg selpercatinib (2 x 80 mg capsules) Reference
| BG002 | Total | Total of all reporting groups |
| 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 | Number | participants |
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160 mg Selpercatinib (tablet) administered orally according to the randomization schedule.
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|
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| Primary | 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 at least one dose of selpercatinib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*hr/mL) | Day 1 and Day 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 312 hours (h) postdose; |
|
|
|
|
| Primary | 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 at least one dose of selpercatinib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1 and Day 15: Predose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 312 hours (h) postdose; |
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|
|
|
| 0 |
| 216 |
| 0 |
| 216 |
| 0 |
| 216 |
| EG001 | 160 mg Selpercatinib (1 x 160 mg Test) | 160 mg selpercatinib (1 x 160 mg tablet) will be administered orally on Day 1 and Day 15. | 0 | 212 | 0 | 212 | 0 | 212 |
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