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| ID | Type | Description | Link |
|---|---|---|---|
| J2G-OX-JZJS | Other Identifier | Eli Lilly and Company | |
| LOXO-RET-18026 | Other Identifier | Loxo Oncology, Inc. |
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| Name | Class |
|---|---|
| Loxo Oncology, Inc. | INDUSTRY |
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The main purpose of this study is to assess the effect of selpercatinib on how fast repaglinide gets into the blood stream and how long it takes the body to remove it when administered in healthy participants. Information about safety and tolerability will be collected. The study will last up to 12 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: Repaglinide | Experimental |
|
|
| Period 2: Selpercatinib + Repaglinide | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repaglinide | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Repaglinide | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) | |
| PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Repaglinide | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) | |
| PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Repaglinide | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) | |
| PK: Maximum Observed Concentration (Cmax) of Repaglinide | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) | |
| PK: Time to Reach Maximum Observed Concentration (Tmax) of Repaglinide | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) | |
| PK: Apparent Terminal Elimination Rate Constant (Kel) of Repaglindide | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Area Under the Concentration-time Curve, From Time 0 to the 12 Hour (AUC0-12) of Selpercatinib | Period 2: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) | |
| PK: Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) 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 |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Period 1: Repaglinide |
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| FG001 | Period 2: Selpercatinib + Repaglinide |
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| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| 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 | All Participants |
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| 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): Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Repaglinide | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) |
|
Baseline to Follow-up (up to Day 2 for Period 1; up to Day 11 for Period 2)
Safety analysis population: 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 | Period 1: Repaglinide (Day 1) |
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood glucose decreased | Investigations | MedDRA Version 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 08005455979 | 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 | Feb 20, 2019 | Nov 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 22, 2019 | Aug 22, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C072379 | repaglinide |
| C000656166 | selpercatinib |
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| Selpercatinib | Drug | Administered orally. |
|
|
| PK: Apparent First-order Terminal Elimination Half-life (t½) of Repaglinide | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) |
| PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Repaglinide | PK: CL/F of Repaglinide | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) |
| PK: Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Repaglinide | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) |
| Period 2: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) |
| PK: Maximum Observed Concentration (Cmax) of Selpercatinib | Period 2: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) |
| PK: Time to Reach Maximum Observed Concentration (Tmax) of Selpercatinib | Period 2: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) |
| PK: Area Under the Concentration-time Curve During a Dosing Interval (Tau) at Steady State (AUCtau) of Selpercatinib | Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) |
| PK: Maximum Observed Concentration at Steady-state (Cmax,ss) of Selpertcatinib | Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) |
| PK: Concentration Observed at the End of the Dosing Interval (Ctrough) of Selpercatinib | Period 2: Predose at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 |
| PK: Time to Reach Maximum Observed Concentration at Steady-state (Tmax,ss) of Selpercatinib | Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) |
| PK: Apparent Total Plasma Clearance at Steady State After Oral/Extravascular Administration (CL,ss/F) of Selpercatinib | Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) |
| COMPLETED |
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| NOT COMPLETED |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| 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 Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Repaglinide | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) |
|
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| Primary | PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Repaglinide | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | percent AUC extrapolation | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) |
|
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| Primary | PK: Maximum Observed Concentration (Cmax) of Repaglinide | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) |
|
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| Primary | PK: Time to Reach Maximum Observed Concentration (Tmax) of Repaglinide | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) |
|
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| Primary | PK: Apparent Terminal Elimination Rate Constant (Kel) of Repaglindide | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | One per hour (1/h) | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) |
|
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| Primary | PK: Apparent First-order Terminal Elimination Half-life (t½) of Repaglinide | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) |
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| Primary | PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Repaglinide | PK: CL/F of Repaglinide | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per Hour (L/h) | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) |
|
|
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| Primary | PK: Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Repaglinide | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 hours post dose) |
|
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| Secondary | PK: Area Under the Concentration-time Curve, From Time 0 to the 12 Hour (AUC0-12) of Selpercatinib | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Period 2: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) |
|
|
|
| Secondary | PK: Area Under the Concentration-time Curve, From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Period 2: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) |
|
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|
| Secondary | PK: Maximum Observed Concentration (Cmax) of Selpercatinib | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 2: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) |
|
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| Secondary | PK: Time to Reach Maximum Observed Concentration (Tmax) of Selpercatinib | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Period 2: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) |
|
|
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| Secondary | PK: Area Under the Concentration-time Curve During a Dosing Interval (Tau) at Steady State (AUCtau) of Selpercatinib | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) |
|
|
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| Secondary | PK: Maximum Observed Concentration at Steady-state (Cmax,ss) of Selpertcatinib | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) |
|
|
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| Secondary | PK: Concentration Observed at the End of the Dosing Interval (Ctrough) of Selpercatinib | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome. 'Number analyzed' signifies participants with available data at specified timepoints. | Posted | Mean | Standard Deviation | ng/mL | Period 2: Predose at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 |
|
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| Secondary | PK: Time to Reach Maximum Observed Concentration at Steady-state (Tmax,ss) of Selpercatinib | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) |
|
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| Secondary | PK: Apparent Total Plasma Clearance at Steady State After Oral/Extravascular Administration (CL,ss/F) of Selpercatinib | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per Hours (L/h) | Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose) |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 7 |
| 16 |
| EG001 | Period 2: Selpercatinib (Day 1 to Day 9) |
| 0 | 16 | 0 | 16 | 7 | 16 |
| EG002 | Period 2: Selpercatinib + Repaglinide (Day 10) |
| 0 | 13 | 0 | 13 | 11 | 13 |
| Electrocardiogram QT prolonged | Investigations | MedDRA Version 21.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 21.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA Version 21.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA Version 21.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA Version 21.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 21.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 21.1 | Systematic Assessment |
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Not provided
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| Day 3 |
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| Day 4 |
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| Day 5 |
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| Day 6 |
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| Day 7 |
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| Day 8 |
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| Day 9 |
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