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| ID | Type | Description | Link |
|---|---|---|---|
| J2G-OX-JZJG | Other Identifier | Eli Lilly and Company | |
| LOXO-RET-18032 | 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 (LY3527723) on the heart rate-corrected QT (QTc) interval. The study will last up to 41 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1: ABCD | Experimental | Period 1: 320 milligram (mg) Selpercatinib and Selpercatinib matching placebo (Treatment A) Period 2: 640 mg Selpercatinib (Treatment B) Period 3: 400 mg moxifloxacin (Treatment C) Period 4: Selpercatinib matching placebo (Treatment D) Participants received their assigned treatments in each of the above treatment period on Day 1 orally. |
|
| Treatment Sequence 2: BDAC | Experimental | Period 1: 640 mg Selpercatinib (Treatment B) Period 2: Selpercatinib matching placebo (Treatment D) Period 3: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A) Period 4: 400 mg moxifloxacin (Treatment C) Participants received their assigned treatments in each of the above treatment period on Day 1 orally. |
|
| Treatment Sequence 3: CADB | Active Comparator | Period 1: 400 mg moxifloxacin (Treatment C) Period 2: Selpercatinib matching placebo (Treatment D) Period 3: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A) Period 4: 640 mg Selpercatinib (Treatment B) Participants received their assigned treatments in each of the above treatment period on Day 1 orally. Period Title: Treatment Period 1 |
|
| Treatment Sequence 4: DCBA | Placebo Comparator | Period 1: Selpercatinib matching placebo (Treatment D) Period 2: 400 mg moxifloxacin (Treatment C) Period 3: 640 mg Selpercatinib (Treatment B) Period 4: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A) Participants received their assigned treatments in each of the above treatment period on Day 1 orally. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selpercatinib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiodynamics: Placebo-corrected Change From Baseline in QT Interval Corrected Using Fridericia's Correction (QTcF) (ΔΔQTcF) for Treatments A, B, and C | The cardiodynamic assessment was performed through 12-lead electrocardiogram (ECG) extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcF. Placebo-corrected change from baseline in QTcF (ΔΔQTcF) was calculated based on model-predicted effect | Pre-dose, -0.25, -0.5, -0.25, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, and 24 hours post-dose |
| Pharmacokinetics (PK): Area Under the Concentration-time Curve From Time 0 to the Time of the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib | PK: AUC0-t of Selpercatinib is reported. | Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib | PK: AUC0-inf of Selpercatinib is reported. | Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib | PK: AUC%extrap of Selpercatinib is reported. | Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| PK: Maximum Observed Concentration (Cmax) of Selpercatinib | PK: Cmax of Selpercatinib is reported. |
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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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Participants were randomized to 4 treatment sequences (ABCD, BDAC, CADB, and DCBA), with each sequence having 4 periods where participants were crossed over between the periods. There was a washout period of 10 days between dosing in each period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1: ABCD | Period 1: 320 milligram (mg) Selpercatinib and Selpercatinib matching placebo (Treatment A) Period 2: 640 mg Selpercatinib (Treatment B) Period 3: 400 mg moxifloxacin (Treatment C) Period 4: Selpercatinib matching placebo (Treatment D) Participants received their assigned treatments in each of the above treatment period on Day 1 orally. |
| FG001 | Treatment Sequence 2: BDAC | Period 1: 640 mg Selpercatinib (Treatment B) Period 2: Selpercatinib matching placebo (Treatment D) Period 3: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A) Period 4: 400 mg moxifloxacin (Treatment C) Participants received their assigned treatments in each of the above treatment period on Day 1 orally. |
| FG002 | Treatment Sequence 3: CADB | Period 1: 400 mg moxifloxacin (Treatment C) Period 2: Selpercatinib matching placebo (Treatment D) Period 3: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A) Period 4: 640 mg Selpercatinib (Treatment B) Participants received their assigned treatments in each of the above treatment period on Day 1 orally. |
| FG003 | Treatment Sequence 4: DCBA | Period 1: Selpercatinib matching placebo (Treatment D) Period 2: 400 mg moxifloxacin (Treatment C) Period 3: 640 mg Selpercatinib (Treatment B) Period 4: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A) Participants received their assigned treatments in each of the above treatment period on Day 1 orally. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
| ||||||||||||||||
| Treatment Period 2 |
| ||||||||||||||||
| Treatment Period 3 |
| ||||||||||||||||
| Treatment Period 4 |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1: ABCD | Period 1: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A) Period 2: 640 mg Selpercatinib (Treatment B) Period 3: 400 mg moxifloxacin (Treatment C) Period 4: Selpercatinib matching placebo (Treatment D) Participants received their assigned treatments in each of the above treatment period on Day 1 orally. |
| 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 | Cardiodynamics: Placebo-corrected Change From Baseline in QT Interval Corrected Using Fridericia's Correction (QTcF) (ΔΔQTcF) for Treatments A, B, and C | The cardiodynamic assessment was performed through 12-lead electrocardiogram (ECG) extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcF. Placebo-corrected change from baseline in QTcF (ΔΔQTcF) was calculated based on model-predicted effect | All randomized participants who received at least one dose of selpercatinib or moxifloxacin with measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTc value. | Posted | Least Squares Mean | 90% Confidence Interval | milliseconds | Pre-dose, -0.25, -0.5, -0.25, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, and 24 hours post-dose |
|
Baseline up to 41 Days
All participants who received at least one dose of the study drug. Per analysis plan adverse events were analyzed per each dose level.
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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 | 320 mg Selpercatinib | Participants received 320 mg Selpercatinib and administered orally on day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | 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 | Apr 25, 2019 | Aug 19, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 24, 2019 | Aug 19, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000656166 | selpercatinib |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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|
| Moxifloxacin | Drug | Administered orally |
|
| Placebo | Drug | Administered orally. |
|
| Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| PK: Time to Reach Cmax (Tmax) of Selpercatinib | PK: Tmax of Selpercatinib is reported. | Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| PK: Apparent First Order Terminal Elimination Rate Constant (Kel) of Selpercatinib | PK: Kel of Selpercatinib is reported. | Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib | PK: t½ of Selpercatinib is reported. | Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 |
| Treatment Sequence 2: BDAC |
Period 1: 640 mg Selpercatinib (Treatment B) Period 2: Selpercatinib matching placebo (Treatment D) Period 3: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A) Period 4: 400 mg moxifloxacin (Treatment C) Participants received their assigned treatments in each of the above treatment period on Day 1 orally. |
| BG002 | Treatment Sequence 3: CADB | Period 1: 400 mg moxifloxacin (Treatment C) Period 2: Selpercatinib matching placebo (Treatment D) Period 3: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A) Period 4: 640 mg Selpercatinib (Treatment B) Participants received their assigned treatments in each of the above treatment period on Day 1 orally. |
| BG003 | Treatment Sequence 4: DCBA | Period 1: Selpercatinib matching placebo (Treatment D) Period 2: 400 mg moxifloxacin (Treatment C) Period 3: 640 mg Selpercatinib (Treatment B) Period 4: 320 mg Selpercatinib and Selpercatinib matching placebo (Treatment A) Participants received their assigned treatments in each of the above treatment period on Day 1 orally. |
| 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 | Count of Participants | Participants | No |
|
| OG000 | 320 mg Selpercatinib (Treatment A) | Participants received single oral dose of 320 mg selpercatinib. |
| OG001 | 640 mg Selpercatnib (Treatment B) | Participants received single oral dose of 640 mg selpercatinib. |
| OG002 | 400 mg Moxifloxacin (Treatment C) | Participants received single oral dose of 400 mg moxifloxacin. |
|
|
| Primary | Pharmacokinetics (PK): Area Under the Concentration-time Curve From Time 0 to the Time of the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib | PK: AUC0-t of Selpercatinib is reported. | All randomized participants who received at least one dose of selpercatinib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per millilitre (ng*h/mL) | Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
| Primary | PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib | PK: AUC0-inf of Selpercatinib is reported. | All randomized participants who received at least one dose of selpercatinib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
| Primary | PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib | PK: AUC%extrap of Selpercatinib is reported. | All randomized participants who received at least one dose of selpercatinib and had evaluable PK data. | Posted | Mean | Standard Deviation | percentage of AUC0-inf extrapolated | Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
| Primary | PK: Maximum Observed Concentration (Cmax) of Selpercatinib | PK: Cmax of Selpercatinib is reported. | All randomized participants who received at least one dose of selpercatinib and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
| Primary | PK: Time to Reach Cmax (Tmax) of Selpercatinib | PK: Tmax of Selpercatinib is reported. | All randomized participants who received at least one dose of selpercatinib and had evaluable PK data. | Posted | Median | Full Range | hour | Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
| Primary | PK: Apparent First Order Terminal Elimination Rate Constant (Kel) of Selpercatinib | PK: Kel of Selpercatinib is reported. | All randomized participants who received at least one dose of selpercatinib and had evaluable PK data. | Posted | Mean | Standard Deviation | 1/hour | Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
| Primary | PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib | PK: t½ of Selpercatinib is reported. | All randomized participants who received at least one dose of selpercatinib and had evaluable PK data. | Posted | Mean | Standard Deviation | hour | Pre-dose, 0.25, 0.5, 0.75, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 6 |
| 32 |
| EG001 | 640 mg Selpercatinib | Participants received 640 mg Selpercatinib administered orally on day 1. | 0 | 32 | 0 | 32 | 2 | 32 |
| EG002 | 400 mg Moxifloxacin | Participants received 400 mg moxifloxacin administered orally on day 1. | 0 | 32 | 0 | 32 | 0 | 32 |
| EG003 | Selpercatinib Matching Placebo | Participants received Selpercatinib matching placebo administered orally on day 1. | 0 | 32 | 0 | 32 | 4 | 32 |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
Not provided
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |