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| ID | Type | Description | Link |
|---|---|---|---|
| J2G-OX-JZJD | Other Identifier | Eli Lilly and Company | |
| LOXO-RET-18022 | 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 how selpercatinib gets into the blood stream and how long it takes the body to remove it when administered to participants with impaired hepatic function compared to healthy participants. Information about safety and tolerability will be collected. The study will last up to about 7 weeks, inclusive of screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 160 milligram (mg) Selpercatinib: Normal Hepatic Function | Experimental | 160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1. |
|
| 160 mg Selpercatinib: Mild Hepatic Impairment | Experimental | 160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh [CP] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1. |
|
| 160 mg Selpercatinib: Moderate Hepatic Impairment | Experimental | 160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1. |
|
| 160 mg Selpercatinib: Severe Hepatic Impairment | Experimental | 160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1. |
|
| 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 was reported. | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| PK: Time to Reach Cmax (Tmax) of Selpercatinib | PK: Tmax of Selpercatinib was reported. | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| PK: Area Under the Concentration-time Curve (AUC), From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib | PK: AUC0-t was calculated using the linear trapezoidal rule for increasing and decreasing concentrations. | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| PK: AUC Extrapolated to Infinity (AUC0-∞) of Selpercatinib | PK: Area under the plasma concentration time curve extrapolated to infinity, calculated as AUC(0-t) + Ct/λZ, where Ct is the last measurable concentration and λZ is the apparent terminal elimination rate constant. | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| PK: Percentage Extrapolation for AUC (%AUCextrap) of Selpercatinib | PK: %AUCextrap of Selpercatinib was reported. | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| PK: Apparent Terminal Elimination Rate Constant (λz) of Selpercatinib |
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Inclusion Criteria:
Female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
Males who are capable of fathering a child must agree to use one of the following methods of contraception from the time of the dose administration through 6 months after dose administration:
Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study
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 |
|---|---|---|---|---|---|---|
| Orange County Research Institute | Anaheim | California | 92801 | United States | ||
| National Institute of Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | 160 Milligram (mg) Selpercatinib: Normal Hepatic Function | 160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1. |
| FG001 | 160 mg Selpercatinib: Mild Hepatic Impairment | 160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh [CP] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1. |
| FG002 | 160 mg Selpercatinib: Moderate Hepatic Impairment | 160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1. |
| FG003 | 160 mg Selpercatinib: Severe Hepatic Impairment | 160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 160 mg Selpercatinib: Normal Hepatic Function | 160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1. |
| BG001 | 160 mg Selpercatinib: Mild Hepatic Impairment |
| 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 was reported. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose 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: Normal Hepatic Function | 160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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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 | Dec 19, 2018 | Oct 31, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2019 | Oct 31, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000656166 | selpercatinib |
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|
PK: Apparent terminal elimination rate constant, where λZ is the magnitude of the slope of the linear regression of the log concentration versus-time profile during the terminal phase. |
| Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| PK: Apparent Terminal Elimination Half-life (t1/2) of Selpercatinib | PK: Apparent terminal elimination half-life (whenever possible), where t1/2 = natural log (ln)(2)/λZ. | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| PK: Apparent Systemic Clearance (CL/F) of Selpercatinib | CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in liter/hour (L/hr). | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| PK: Apparent Volume of Distribution During the Terminal Phase (Vd/F) of Selpercatinib | PK: Vd/F was calculated as CL/F/λZ. | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| PK: Mean Residence Time (MRT) of Selpercatinib | PK: MRT represents the average time the drug (selpercatinib) stays in the body. | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module. | Baseline up to Week 7 |
| Monterey Park |
| California |
| 91754 |
| United States |
| Orange County Research Center | Tustin | California | 92780 | United States |
| Riverside Clinical Research | Edgewater | Florida | 32132 | United States |
| Clinical Pharmacology of Miami | Miami | Florida | 33014 | United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| The Texas Liver Institute | San Antonio | Texas | 78215 | United States |
160 mg selpercatinib administered orally to participants with mild hepatic impairment per CP classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
| BG002 | 160 mg Selpercatinib: Moderate Hepatic Impairment | 160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1. |
| BG003 | 160 mg Selpercatinib: Severe Hepatic Impairment | 160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1. |
| BG004 | Total | Total of all reporting groups |
| 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 | Number | participants |
|
160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh [CP] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
| OG002 | 160 mg Selpercatinib: Moderate Hepatic Impairment | 160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1. |
| OG003 | 160 mg Selpercatinib: Severe Hepatic Impairment | 160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1. |
|
|
|
| Primary | PK: Time to Reach Cmax (Tmax) of Selpercatinib | PK: Tmax of Selpercatinib was reported. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Median | Full Range | hour | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
| Primary | PK: Area Under the Concentration-time Curve (AUC), From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib | PK: AUC0-t was calculated using the linear trapezoidal rule for increasing and decreasing concentrations. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/ mL) | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
|
| Primary | PK: AUC Extrapolated to Infinity (AUC0-∞) of Selpercatinib | PK: Area under the plasma concentration time curve extrapolated to infinity, calculated as AUC(0-t) + Ct/λZ, where Ct is the last measurable concentration and λZ is the apparent terminal elimination rate constant. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/ mL) | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
|
| Primary | PK: Percentage Extrapolation for AUC (%AUCextrap) of Selpercatinib | PK: %AUCextrap of Selpercatinib was reported. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Mean | Standard Deviation | percentage of (%) of AUCextrap | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
| Primary | PK: Apparent Terminal Elimination Rate Constant (λz) of Selpercatinib | PK: Apparent terminal elimination rate constant, where λZ is the magnitude of the slope of the linear regression of the log concentration versus-time profile during the terminal phase. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hour (1/h) | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
| Primary | PK: Apparent Terminal Elimination Half-life (t1/2) of Selpercatinib | PK: Apparent terminal elimination half-life (whenever possible), where t1/2 = natural log (ln)(2)/λZ. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Mean | Standard Deviation | hour | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
| Primary | PK: Apparent Systemic Clearance (CL/F) of Selpercatinib | CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in liter/hour (L/hr). | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per Hour (L/h) | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
| Primary | PK: Apparent Volume of Distribution During the Terminal Phase (Vd/F) of Selpercatinib | PK: Vd/F was calculated as CL/F/λZ. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
| Primary | PK: Mean Residence Time (MRT) of Selpercatinib | PK: MRT represents the average time the drug (selpercatinib) stays in the body. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
| Primary | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module. | All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment. | Posted | Number | participants | Baseline up to Week 7 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | 160 mg Selpercatinib: Mild Hepatic Impairment | 160 mg selpercatinib administered orally to participants with mild hepatic impairment per CP classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG002 | 160 mg Selpercatinib: Moderate Hepatic Impairment | 160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | 160 mg Selpercatinib: Severe Hepatic Impairment | 160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1. | 0 | 8 | 0 | 8 | 0 | 8 |
| Dry mouth | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
Not provided
| t-test, 2 sided |
| 0.8341 |
| Geometric Mean Ratio |
| 92.4 |
| 2-Sided |
| 90 |
| 46.4 |
| 183.9 |
Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale. |
| Other |
| t-test, 2 sided | 0.1159 | Geometric Mean Ratio | 169.1 | 2-Sided | 90 | 97.1 | 294.6 | Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale. | Other |
| t-test, 2 sided |
| 0.8322 |
| Geometric Mean Ratio |
| 92.3 |
| 2-Sided |
| 90 |
| 46.5 |
| 183.3 |
Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale. |
| Other |
| t-test, 2 sided | 0.1131 | Geometric Mean Ratio | 169.6 | 2-Sided | 90 | 97.6 | 294.6 | Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale. | Other |