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| ID | Type | Description | Link |
|---|---|---|---|
| J2N-MC-JZNK | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Loxo Oncology, Inc. | INDUSTRY |
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The main purpose of this study is to conduct blood tests to measure how much pirtobrutinib (LOXO-305) is in the bloodstream and how the body handles and eliminates pirtobrutinib (LOXO-305) after meals and on an empty stomach. The study will also evaluate the safety and tolerability of pirtobrutinib (LOXO-305). Participants will stay in this study for up to 53 days (screening through follow-up call).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 mg Pirtobrutinib: Treatment AB | Experimental | Participants received a single oral dose of 200 milligrams (mg) of pirtobrutinib administered in the morning on Day 1, under fasted conditions (Treatment A) followed by 200 mg pirtobrutinib administered orally in the morning on Day 8, under fed condition (Treatment B). A washout period of 7 days was maintained between Treatments A and B. |
|
| 200 mg Pirtobrutinib: Treatment BA | Experimental | Participants received a single oral dose of 200 mg pirtobrutinib administered in the morning on Day 1, under fed conditions (Treatment B) followed by 200 mg of pirtobrutinib administered orally in the morning on Day 8, under fasted conditions (Treatment A). A washout period of 7 days was maintained between Treatments A and B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirtobrutinib | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib | PK: AUC0-24 of pirtobrutinib was reported. | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 1 and 8 |
| PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib | PK: AUC0-t of pirtobrutinib was reported. | 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, and 168 hours post-dose on Days 1 and 8 |
| PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Pirtobrutinib | PK: AUC0-inf of pirtobrutinib was reported. | 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, and 168 hours post-dose on Days 1 and 8 |
| PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib | PK: %AUCextrap of pirtobrutinib was reported. | 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, and 168 hours post-dose on Days 1 and 8 |
| PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib | PK: CL/F of pirtobrutinib was reported. | 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, and 168 hours post-dose on Days 1 and 8 |
| PK: Apparent Plasma Terminal Elimination Half-life (t½) of Pirtobrutinib | PK: t½ of pirtobrutinib was reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renee Ward, MD, PhD | Loxo Oncology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Daytona Beach | Florida | 32117 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 200 mg Pirtobrutinib: Treatment AB | Participants received a single oral dose of 200 milligrams (mg) of pirtobrutinib administered in the morning on Day 1, under fasted conditions (Treatment A) followed by 200 mg pirtobrutinib administered orally in the morning on Day 8, under fed condition (Treatment B). A washout period of 7 days was maintained between Treatments A and B. |
| FG001 | 200 mg Pirtobrutinib: Treatment BA | Participants received a single oral dose of 200 mg pirtobrutinib administered in the morning on Day 1, under fed conditions (Treatment B) followed by 200 mg of pirtobrutinib administered orally in the morning on Day 8, under fasted conditions (Treatment A). A washout period of 7 days was maintained between Treatments A and B. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants who received at least 1 dose of Pirtobrutinib.
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| ID | Title | Description |
|---|---|---|
| BG000 | 200 mg Pirtobrutinib: Treatment AB | Participants received a single oral dose of 200 mg of pirtobrutinib administered in the morning on Day 1, under fasted conditions (Treatment A) followed by 200 mg pirtobrutinib administered orally in the morning on Day 8, under fed condition (Treatment B). A washout period of 7 days was maintained between Treatments A and B. |
| 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 24 Hours Post-dose (AUC0-24) of Pirtobrutinib | PK: AUC0-24 of pirtobrutinib was reported. | The PK Population was consisted of all participants who had received 1 dose of pirtobrutinib, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour nanogram per milliliter (h*ng/mL) | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 1 and 8 |
|
Baseline to end of follow-up (up to 24 days)
All participants who received at least 1 dose of Pirtobrutinib.
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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 | 200 mg Pirtobrutinib (Fasted) | Participants received a single oral dose of 200 mg pirtobrutinib was administered in the morning on Day 1 or Day 8, under fasted conditions in Treatment A and B. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 23.0 | 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 | Dec 2, 2020 | Jan 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 11, 2021 | Jan 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000723100 | pirtobrutinib |
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| 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, and 168 hours post-dose on Days 1 and 8 |
| PK: Maximum Observed Concentration (Cmax) of Pirtobrutinib | PK: Cmax of pirtobrutinib was reported. | 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, and 168 hours post-dose on Days 1 and 8 |
| PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib | PK: Tmax of pirtobrutinib was reported. | 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, and 168 hours post-dose on Days 1 and 8 |
| PK: Apparent Terminal Elimination Rate Constant (Lambda Z) of Pirtobrutinib | PK: Lambda Z of pirtobrutinib was reported. | 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, and 168 hours post-dose on Days 1 and 8 |
| PK: Apparent Volume of Distribution at the Terminal Phase (Vz/F) of Pirtobrutinib | PK: Vz/F of pirtobrutinib was reported | 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, and 168 hours post-dose on Days 1 and 8 |
| BG001 |
| 200 mg Pirtobrutinib: Treatment BA |
Participants received a single oral dose of 200 mg pirtobrutinib administered in the morning on Day 1, under fed conditions (Treatment B) followed by 200 mg of pirtobrutinib administered orally in the morning on Day 8, under fasted conditions (Treatment A). A washout period of 7 days was maintained between Treatments A and B. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| 200 mg Pirtobrutinib (Fed) |
Participants received a single oral dose of 200 mg pirtobrutinib was administered in the morning on Day 1 or Day 8, under fed conditions in Treatment A and B. |
|
|
| Primary | PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib | PK: AUC0-t of pirtobrutinib was reported. | The PK Population was consisted of all participants who had received 1 dose of pirtobrutinib, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 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, and 168 hours post-dose on Days 1 and 8 |
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|
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| Primary | PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Pirtobrutinib | PK: AUC0-inf of pirtobrutinib was reported. | The PK Population was consisted of all participants who had received 1 dose of pirtobrutinib, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 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, and 168 hours post-dose on Days 1 and 8 |
|
|
|
| Primary | PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib | PK: %AUCextrap of pirtobrutinib was reported. | The PK Population was consisted of all participants who had received 1 dose of pirtobrutinib, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of AUCextrap | 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, and 168 hours post-dose on Days 1 and 8 |
|
|
|
| Primary | PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib | PK: CL/F of pirtobrutinib was reported. | The PK Population was consisted of all participants who had received 1 dose of pirtobrutinib, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed.. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter per hour (L/h) | 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, and 168 hours post-dose on Days 1 and 8 |
|
|
|
| Primary | PK: Apparent Plasma Terminal Elimination Half-life (t½) of Pirtobrutinib | PK: t½ of pirtobrutinib was reported. | The PK Population was consisted of all participants who had received 1 dose of pirtobrutinib, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | 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, and 168 hours post-dose on Days 1 and 8 |
|
|
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| Primary | PK: Maximum Observed Concentration (Cmax) of Pirtobrutinib | PK: Cmax of pirtobrutinib was reported. | The PK Population was consisted of all participants who had received 1 dose of pirtobrutinib, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | 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, and 168 hours post-dose on Days 1 and 8 |
|
|
|
| Primary | PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib | PK: Tmax of pirtobrutinib was reported. | The PK Population was consisted of all participants who had received 1 dose of pirtobrutinib, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed. | Posted | Median | Full Range | hour | 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, and 168 hours post-dose on Days 1 and 8 |
|
|
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| Primary | PK: Apparent Terminal Elimination Rate Constant (Lambda Z) of Pirtobrutinib | PK: Lambda Z of pirtobrutinib was reported. | The PK Population was consisted of all participants who had received 1 dose of pirtobrutinib, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed. | Posted | Number | 1/hour (1/h) | 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, and 168 hours post-dose on Days 1 and 8 |
|
|
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| Primary | PK: Apparent Volume of Distribution at the Terminal Phase (Vz/F) of Pirtobrutinib | PK: Vz/F of pirtobrutinib was reported | The PK Population was consisted of all participants who had received 1 dose of pirtobrutinib, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter | 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, and 168 hours post-dose on Days 1 and 8 |
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| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | 200 mg Pirtobrutinib (Fed) | Participants received a single oral dose of 200 mg pirtobrutinib was administered in the morning on Day 1 or Day 8, under fed conditions in Treatment A and B. | 0 | 20 | 0 | 20 | 2 | 20 |
| Dysgeusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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