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| ID | Type | Description | Link |
|---|---|---|---|
| J2G-OX-JZJL | Other Identifier | Eli Lilly and Company | |
| LOXO-RET-19075 | 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 learn about how H2 antagonist (ranitidine) and proton pump inhibitor (PPI) (omeprazole) affect Selpercatinib in healthy participants. Information about safety and tolerability will be collected. The study will last up to about 9 weeks, inclusive of screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 160 milligram (mg) Selpercatinib | Experimental | Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1). |
|
| 150 mg Ranitidine dosed with 160 mg Selpercatinib | Experimental | Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12). |
|
| 40 mg Omeprazole dosed with 160 mg Selpercatinib | Experimental | Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selpercatinib | 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 Selpercatinib | PK: AUC0-t of Selpercatinib. The analysis of variance (ANOVA) model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric least squares (LS) means and the difference between treatment geometric LS means, as well as their corresponding 90% confidence intervals (CIs). The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses. | PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
| PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib | PK: AUC0-inf of Selpercatinib. The ANOVA model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric LS means and the difference between treatment geometric LS means, as well as their corresponding 90% CIs. The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses. | PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
| PK: Percentage of Area Under the Plasma Concentration-Time Curve (AUC) That is Due to Extrapolation From Last Measurable Concentration to Infinity (%AUCextrap) of Selpercatinib | PK: %AUCextrap of Selpercatinib | PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
| PK: Maximum Observed Plasma Concentration (Cmax) 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 Unit, Inc. | Madison | Wisconsin | 53704 | United States |
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This is a fixed sequence study where participants receive Selpercatinib in Period 1, Selpercatinib in combination with Ranitidine in Period 2, and Selpercatinib in combination with Omeprazole in Period 3.
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| ID | Title | Description |
|---|---|---|
| FG000 | 160 mg Selpercatinib | Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1). |
| FG001 | 150 mg Ranitidine Dosed With 160 mg Selpercatinib | Participants received 150 mg ranitidine twice a day (BID) orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12). |
| FG002 | 40 mg Omeprazole Dosed With 160 mg Selpercatinib | Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - Day 1 to Day 8 |
| ||||||||||||||||
| Period 2 - Day 8 to Day 19 |
| ||||||||||||||||
| Period 3 - Day 19 to Day 29 |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1). Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12). Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Selpercatinib | PK: AUC0-t of Selpercatinib. The analysis of variance (ANOVA) model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric least squares (LS) means and the difference between treatment geometric LS means, as well as their corresponding 90% confidence intervals (CIs). The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses. | All enrolled or randomized participants who received at least one dose of study drug with evaluable data for AUC0-t. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanograms per milliliter(h*ng/mL) | PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
|
Baseline through Day 37
All enrolled or randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
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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 | Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 22.0 | 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 | Jun 20, 2019 | Jan 12, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 12, 2019 | Jan 12, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000656166 | selpercatinib |
| D011899 | Ranitidine |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
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|
| Ranitidine | Drug | Administered orally. |
|
| Omeprazole | Drug | Administered orally. |
|
PK: Cmax of Selpercatinib. The ANOVA model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric LS means and the difference between treatment geometric LS means, as well as their corresponding 90% CIs. The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses.
| PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
| PK: Time of Maximum Observed Concentration (Tmax) of Selpercatinib | PK: Tmax of Selpercatinib | PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
| PK: Apparent Volume of Distribution (Vz/F) | PK: Vz/F of Selpercatinib | PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
| PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib | PK: CL/F of Selpercatinib | PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
| PK: Apparent Terminal Elimination Half-life (t½) of Selpercatinib | PK: t½ of Selpercatinib | PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
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| NOT COMPLETED |
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| Participants |
| No |
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| 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 |
|
| OG000 |
| 160 mg Selpercatinib |
Participants received a single oral dose of 160 mg Selpercatinib (Study Day 1). |
| OG001 | 150 mg Ranitidine Dosed With 160 mg Selpercatinib | Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12). |
| OG002 | 40 mg Omeprazole Dosed With 160 mg Selpercatinib | Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23). |
|
|
|
| Primary | PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib | PK: AUC0-inf of Selpercatinib. The ANOVA model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric LS means and the difference between treatment geometric LS means, as well as their corresponding 90% CIs. The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses. | All enrolled or randomized participants who received at least one dose of study drug with evaluable data for AUC0-inf. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
|
|
|
|
| Primary | PK: Percentage of Area Under the Plasma Concentration-Time Curve (AUC) That is Due to Extrapolation From Last Measurable Concentration to Infinity (%AUCextrap) of Selpercatinib | PK: %AUCextrap of Selpercatinib | All enrolled or randomized participants who received at least one dose of study drug with evaluable data for %AUCextrap. | Posted | Median | Full Range | percentage of (%) of AUCextrap | PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
|
|
|
| Primary | PK: Maximum Observed Plasma Concentration (Cmax) of Selpercatinib | PK: Cmax of Selpercatinib. The ANOVA model was performed on the natural log (ln)-transformed PK parameters and included calculation of geometric LS means and the difference between treatment geometric LS means, as well as their corresponding 90% CIs. The ratios of geometric LS mean and 90% CI for the ratio of the PK parameter for each comparison was constructed using the exponentiation of the difference and the CIs from the ANOVA analyses. | All enrolled or randomized participants who received at least one dose of study drug with evaluable data for Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
|
|
|
|
| Primary | PK: Time of Maximum Observed Concentration (Tmax) of Selpercatinib | PK: Tmax of Selpercatinib | All enrolled or randomized participants who received at least one dose of study drug with evaluable data for tmax. | Posted | Median | Full Range | hour | PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
|
|
|
| Primary | PK: Apparent Volume of Distribution (Vz/F) | PK: Vz/F of Selpercatinib | All enrolled or randomized participants who received at least one dose of study drug with evaluable data for Vz/F. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter | PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
|
|
|
| Primary | PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib | PK: CL/F of Selpercatinib | All enrolled or randomized participants who received at least one dose of study drug with evaluable data for CL/F. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter per hour (L/h) | PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
|
|
|
| Primary | PK: Apparent Terminal Elimination Half-life (t½) of Selpercatinib | PK: t½ of Selpercatinib | All enrolled or randomized participants who received at least one dose of study drug with evaluable data for t½. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | PK: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 post Selpercatinib dose on Day 1 - Period 1, Day 12 - Period 2, and Day 23 - Period 3 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 5 |
| 20 |
| EG001 | 150 mg Ranitidine Dosed With 160 mg Selpercatinib | Participants received 150 mg ranitidine twice a day orally for 11 days (Study Days 8 to 18) with a single oral dose of 160 mg Selpercatinib (Study Day 12). | 0 | 20 | 0 | 20 | 11 | 20 |
| EG002 | 40 mg Omeprazole Dosed With 160 mg Selpercatinib | Participants received 40 mg omeprazole once daily for 11 days (Study Days 19 to 29) with a single oral dose of 160 mg Selpercatinib (Study Day 23). | 0 | 17 | 0 | 17 | 4 | 17 |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
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| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Geometric LS Mean Ratio |
| 1.00 |
| 2-Sided |
| 90 |
| 0.888 |
| 1.13 |
| Superiority |
| Geometric LS Mean Ratio |
| 0.782 |
| 2-Sided |
| 90 |
| 0.645 |
| 0.949 |
| Superiority |