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| ID | Type | Description | Link |
|---|---|---|---|
| J2G-MC-JZJV | 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 determine the effect of selpercatinib on the levels of dabigatran in the blood stream and how long it takes the body to remove dabigatran. This study will also look at how safe and well-tolerated of dabigatran when administered in combination with selpercatinib in healthy participants. This study will last approximately 22 to 25 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran + Selpercatinib | Experimental | Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1 and a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) selpercatinib on Day 8. There was a washout period of 7 days between dosing on Days 1 and 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran | Drug | Administered orally. |
| |
| Selpercatinib |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dabigatran | PK: Cmax of Dabigatran | Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours (h) postdose |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Dabigatran | PK: AUC(0-inf) of Dabigatran | Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Cmax of Selpercatinib | PK: Cmax of Selpercatinib | Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose |
| PK: AUC(0-inf) of Selpercatinib | PK: AUC(0-inf) of Selpercatinib |
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran + Selpercatinib | Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1 and a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) Selpercatinib on Day 8. There was a washout period of 7 days between dosing on Days 1 and 8. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran + Selpercatinib | Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1 and a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) Selpercatinib on Day 8. There was a washout period of 7 days between dosing on Days 1 and 8. |
| 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 Dabigatran | PK: Cmax of Dabigatran | All participants who received at least one dose of dabigatran and had evaluable PK. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours (h) postdose |
|
Baseline up to 25 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 | 150 mg Dabigatran | Participants received a single oral dose of 150 milligrams (mg) dabigatran on Day 1. |
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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 | Mar 5, 2021 | Oct 12, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 23, 2021 | Oct 12, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| C000656166 | selpercatinib |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| Drug |
Administered orally. |
|
|
| Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose |
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Selpercatinib | PK: Tmax of Selpercatinib | Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose |
| 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 |
|
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Dabigatran | PK: AUC(0-inf) of Dabigatran | All participants who received at least one dose of dabigatran had evaluable PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Day 1 and Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose |
|
|
|
|
| Secondary | PK: Cmax of Selpercatinib | PK: Cmax of Selpercatinib | All participants who received at least one dose of Selpercatinib and had evaluable PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose |
|
|
|
| Secondary | PK: AUC(0-inf) of Selpercatinib | PK: AUC(0-inf) of Selpercatinib | All participants who received at least one dose of Selpercatinib and had evaluable PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose |
|
|
|
| Secondary | PK: Time of Maximum Observed Drug Concentration (Tmax) of Selpercatinib | PK: Tmax of Selpercatinib | All participants who received at least one dose of Selpercatinib and had evaluable PK. | Posted | Median | Full Range | hours | Day 8: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h postdose |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | 150 mg Dabigatran + 160 mg Selpercatinib | Participants received a single oral dose of 150 mg dabigatran coadministered with a single oral dose of 2 x 80 mg (160 mg) selpercatinib on Day 8. | 0 | 35 | 0 | 35 | 0 | 35 |
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |