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| ID | Type | Description | Link |
|---|---|---|---|
| J2G-MC-JZJQ | Other Identifier | Eli Lilly and Company | |
| LOXO-RET-18015 | 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 food on how fast selpercatinib gets into the bloodstream and how long it takes the body to remove it after a high-fat meal, and the effect of a change in gastric pH after multiple doses of omeprazole on how fast selpercatinib gets into the bloodstream and how long it takes the body to remove it when administered under fasted and fed conditions in healthy participants. The study will also evaluate the safety and tolerability of selpercatinib in healthy participants. The study will last up to 33 days excluding the screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1: ABCD | Experimental | Participants received:
Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. |
|
| Treatment Sequence 2: ABDC | Experimental | Participants received:
Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. |
|
| Treatment Sequence 3: BACD | Experimental | Participants received:
Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. |
| 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 was reported. | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
| PK: Area Under the Concentration-time Curve, From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib | PK: AUC0-inf of Selpercatinib was reported. | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
| PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib | PK: AUC%extrap of Selpercatinib was reported. | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
| PK: Maximum Observed Concentration (Cmax) of Selpercatinib | PK: Cmax of Selpercatinib was reported. | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
| PK: Time to Reach Cmax (Tmax) of Selpercatinib | PK: Tmax of Selpercatinib was reported. | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
| PK: Apparent First Order Terminal Elimination Rate Constant (Kel) of Selpercatinib | PK: Kel of Selpercatinib was 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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(contd.) Treatment C was multiple daily oral doses of 40 mg omeprazole with a single oral dose of 160 mg selpercatinib co-administered under fasting conditions, and Treatment D was multiple daily oral doses of 40 mg omeprazole with 160 mg selpercatinib co-administered under fed condition.
A total of 20 participants were enrolled in this study. Participants were randomly assigned to 1 of 4 treatment sequences (ABCD, ABDC, BACD, and BADC). Treatment A was a single oral dose of 160 milligrams (mg) selpercatinib under fasting condition, Treatment B was a single oral dose of 160 mg selpercatinib under fed condition, (contd.)
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1: ABCD | Participants received:
Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. |
| FG001 | Treatment Sequence 2: ABDC | Participants received:
Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. |
| FG002 | Treatment Sequence 3: BACD | Participants received:
Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. |
| FG003 | Treatment Sequence 3: BADC | Participants received:
Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
| ||||||||||||||||
| Treatment Period 2 |
| ||||||||||||||||
| Treatment Period 3 |
| ||||||||||||||||
| Treatment Period 4 |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1: ABCD | Participants received:
Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. |
| 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 Selpercatinib | PK: AUC0-t of Selpercatinib was reported. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
|
Baseline to End of Follow-up (Up To 39 Days)
All participants who received at least one dose of study drug. Per pre-specified analysis, adverse events were analyzed and reported based on the assigned study treatment.
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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 | Treatment A: 160 mg Selpercatinib (Fasted) | Participants received a single oral dose of 160 mg selpercatinib administered in a fasted state. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | 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 | Jun 11, 2018 | Aug 20, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 6, 2018 | Aug 20, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000656166 | selpercatinib |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Treatment Sequence 4: BADC | Experimental | Participants received:
Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. |
|
|
| Omeprazole | Drug | Administered orally |
|
| Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
| PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib | PK: CL/F of Selpercatinib was reported. | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
| PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib | PK: t½ of Selpercatinib was reported. | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
| Received At Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Received At Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Received At Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Treatment Sequence 2: ABDC | Participants received:
Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. |
| BG002 | Treatment Sequence 3: BACD | Participants received:
Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. |
| BG003 | Treatment Sequence 3: BADC | Participants received:
Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4. |
| 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 |
|
Participants received a single oral dose of 160 mg selpercatinib administered in a fed state. |
| OG002 | Treatment C: 160 mg Selpercatinib + 40 mg Omeprazole (Fasted) | Participants received a single oral dose of 160 mg selpercatinib along with multiple daily oral doses of 40 mg omeprazole administered in a fasted state. |
| OG003 | Treatment D: 160 mg Selpercatinib + 40 mg Omeprazole (Fed) | Participants received a single oral dose of 160 mg selpercatinib along with multiple daily oral doses of 40 mg omeprazole administered in a fed state. |
|
|
| Primary | PK: Area Under the Concentration-time Curve, From Time 0 Extrapolated to Infinity (AUC0-inf) of Selpercatinib | PK: AUC0-inf of Selpercatinib was reported. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
|
|
|
| Primary | PK: Percent of AUC0-inf Extrapolated (AUC%Extrap) of Selpercatinib | PK: AUC%extrap of Selpercatinib was reported. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Mean | Standard Deviation | percentage of AUC0-inf extrapolated | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
|
|
|
| Primary | PK: Maximum Observed Concentration (Cmax) of Selpercatinib | PK: Cmax of Selpercatinib was reported. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
|
|
|
| Primary | PK: Time to Reach Cmax (Tmax) of Selpercatinib | PK: Tmax of Selpercatinib was reported. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Median | Full Range | hours (h) | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
|
|
|
| Primary | PK: Apparent First Order Terminal Elimination Rate Constant (Kel) of Selpercatinib | PK: Kel of Selpercatinib was reported. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Mean | Standard Deviation | 1/hour | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
|
|
|
| Primary | PK: Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of Selpercatinib | PK: CL/F of Selpercatinib was reported. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Mean | Standard Deviation | Liters/hour | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
|
|
|
| Primary | PK: Apparent First-order Terminal Elimination Half-life (t½) of Selpercatinib | PK: t½ of Selpercatinib was reported. | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Mean | Standard Deviation | h | Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose in Periods 1, 2, 3, and 4. |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 3 |
| 20 |
| EG001 | Treatment B: 160 mg Selpercatinib (Fed) | Participants received a single oral dose of 160 mg selpercatinib administered in a fed state. | 0 | 20 | 0 | 20 | 6 | 20 |
| EG002 | Treatment C: 160 mg Selpercatinib + 40 mg Omeprazole (Fasted) | Participants received a single oral dose of 160 mg selpercatinib along with multiple daily oral doses of 40 mg omeprazole administered in a fasted state. | 0 | 19 | 0 | 19 | 7 | 19 |
| EG003 | Treatment D: 160 mg Selpercatinib + 40 mg Omeprazole (Fed) | Participants received a single oral dose of 160 mg selpercatinib along with multiple daily oral doses of 40 mg omeprazole administered in a fed state. | 0 | 20 | 0 | 20 | 8 | 20 |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |