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| ID | Type | Description | Link |
|---|---|---|---|
| J2G-OX-JZJR | Other Identifier | Eli Lilly and Company | |
| LOXO-RET-18017 | 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 midazolam 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 about 6 weeks, inclusive of screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: Midazolam | Experimental |
|
|
| Period 2: Selpercatinib + Midazolam | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | 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 Midazolam and Its Metabolite 1-hydroxymidazolam (1-OH-midazolam) | PK: PK: AUC0-t of midazolam and its metabolite 1-OH-midazolam was reported. | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
| PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Midazolam and Its Metabolite 1-OH-midazolam | PK: PK: AUC0-inf of midazolam and its metabolite 1-OH-midazolam was reported. | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
| PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Midazolam and Its Metabolite 1-OH-midazolam | PK: PK: AUC%extrap of midazolam and its metabolite 1-OH-midazolam was reported. | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
| PK: Maximum Observed Concentration (Cmax) of Midazolam and Its Metabolite 1-OH-midazolam | PK: Cmax of midazolam and its metabolite 1-OH-midazolam was reported. | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
| PK: Time to Reach Maximum Observed Concentration (Tmax) of Midazolam and Its Metabolite 1-OH-midazolam | PK: Tmax of midazolam and its metabolite 1-OH-midazolam was reported. |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Area Under the Concentration-time Curve, From Time 0 to the 12 Hour (AUC0-12) of Selpercatinib | PK: AUC0-12 of Selpercatinib was reported. | 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 |
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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: Midazolam |
|
| FG001 | Period 2: Selpercatinib + Midazolam |
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Period 2 |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants |
|
| 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 Midazolam and Its Metabolite 1-hydroxymidazolam (1-OH-midazolam) | PK: PK: AUC0-t of midazolam and its metabolite 1-OH-midazolam was reported. | 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, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 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.
Not provided
| 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: Midazolam (Day 1) |
|
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperacusis | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
Not provided
| 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 | Jul 30, 2018 | Aug 29, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 17, 2018 | Sep 19, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| C000656166 | selpercatinib |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
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| Selpercatinib | Drug | Administered orally. |
|
|
| Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
| PK: Apparent Terminal Elimination Rate Constant (Kel) of Midazolam and Its Metabolite 1-OH-midazolam | PK: Kel of midazolam and its metabolite 1-OH-midazolam was reported. | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
| PK: Apparent Terminal Elimination Half-life (t½) of Midazolam and Its Metabolite 1-OH-midazolam | PK: t½ of midazolam and its metabolite 1-OH-midazolam was reported. | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
| PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Midazolam | PK: CL/F of midazolam was reported. | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
| PK: Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Midazolam | PK: Vz/F of midazolam was reported. | Period 1: Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
PK: AUC0-tau of Selpercatinib was reported. |
| Period 2: Day 9 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose); Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
| PK: Maximum Observed Concentration (Cmax) of Selpercatinib | PK: Cmax of Selpercatinib was reported. | 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 at Steady-state (Cmax,ss) of Selpercatinib | PK: Cmax,ss of Selpercatinib was reported. | Period 2: Day 9 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose); Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
| PK: Concentration Observed at the End of the Dosing Interval (Ctrough) of Selpercatinib | PK: Ctrough of Selpercatinib was reported. | 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 (Tmax) of Selpercatinib | PK: tmax of Selpercatinib was reported. | 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 at Steady-state (Tmax,ss) of Selpercatinib | PK: Tmax,ss of Selpercatinib was reported. | Period 2: Day 9 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose); Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
| PK: Apparent Total Plasma Clearance at Steady State After Oral/Extravascular Administration (CL,ss/F) of Selpercatinib | PK: CL,ss/F of Selpercatinib was reported. | Period 2: Day 9 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose); Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| 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 |
|
| OG001 |
| Period 2: Selpercatinib+ Midazolam |
|
|
|
| Primary | PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Midazolam and Its Metabolite 1-OH-midazolam | PK: PK: AUC0-inf of midazolam and its metabolite 1-OH-midazolam was reported. | 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, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
|
|
|
| Primary | PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Midazolam and Its Metabolite 1-OH-midazolam | PK: PK: AUC%extrap of midazolam and its metabolite 1-OH-midazolam was reported. | 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, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
|
|
|
| Primary | PK: Maximum Observed Concentration (Cmax) of Midazolam and Its Metabolite 1-OH-midazolam | PK: Cmax of midazolam and its metabolite 1-OH-midazolam was reported. | 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, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
|
|
|
| Primary | PK: Time to Reach Maximum Observed Concentration (Tmax) of Midazolam and Its Metabolite 1-OH-midazolam | PK: Tmax of midazolam and its metabolite 1-OH-midazolam was reported. | 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, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
|
|
|
| Primary | PK: Apparent Terminal Elimination Rate Constant (Kel) of Midazolam and Its Metabolite 1-OH-midazolam | PK: Kel of midazolam and its metabolite 1-OH-midazolam was reported. | 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, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
|
|
|
| Primary | PK: Apparent Terminal Elimination Half-life (t½) of Midazolam and Its Metabolite 1-OH-midazolam | PK: t½ of midazolam and its metabolite 1-OH-midazolam was reported. | 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, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
|
|
|
| Primary | PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Midazolam | PK: CL/F of midazolam was reported. | 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, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
|
|
|
| Primary | PK: Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Midazolam | PK: Vz/F of midazolam was reported. | 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, 6, 8, 12, 16, 24 hours post dose); Period 2: Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
|
|
|
| Secondary | PK: Area Under the Concentration-time Curve, From Time 0 to the 12 Hour (AUC0-12) of Selpercatinib | PK: AUC0-12 of Selpercatinib was reported. | 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 During a Dosing Interval (Tau) at Steady State (AUCtau) of Selpercatinib | PK: AUC0-tau of Selpercatinib was reported. | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Period 2: Day 9 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose); Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
|
|
|
| Secondary | PK: Maximum Observed Concentration (Cmax) of Selpercatinib | PK: Cmax of Selpercatinib was reported. | 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) |
|
|
|
| Secondary | PK: Maximum Observed Concentration at Steady-state (Cmax,ss) of Selpercatinib | PK: Cmax,ss of Selpercatinib was reported. | All participants who complied sufficiently with the protocol and displayed an evaluable PK profile for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 2: Day 9 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose); Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
|
|
|
| Secondary | PK: Concentration Observed at the End of the Dosing Interval (Ctrough) of Selpercatinib | PK: Ctrough of Selpercatinib was reported. | 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 | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Period 2: Predose at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 |
|
|
|
| Secondary | PK: Time to Reach Maximum Observed Concentration (Tmax) of Selpercatinib | PK: tmax of Selpercatinib was reported. | 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) |
|
|
|
| Secondary | PK: Time to Reach Maximum Observed Concentration at Steady-state (Tmax,ss) of Selpercatinib | PK: Tmax,ss of Selpercatinib was reported. | 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 9 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose); Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
|
|
|
| Secondary | PK: Apparent Total Plasma Clearance at Steady State After Oral/Extravascular Administration (CL,ss/F) of Selpercatinib | PK: CL,ss/F of Selpercatinib was reported. | 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 | Geometric Mean | Geometric Coefficient of Variation | Liter per Hours (L/h) | Period 2: Day 9 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post dose); Day 10 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose) |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 5 |
| 16 |
| EG001 | Period 2: Selpercatinib (Day 1 to Day 9) |
| 0 | 16 | 0 | 16 | 12 | 16 |
| EG002 | Period 2: Selpercatinib + Midazolam (Day 10) |
| 0 | 15 | 0 | 15 | 4 | 15 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Asymptomatic bacteriuria | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
Not provided
| D006571 | Heterocyclic Compounds |
|
| 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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