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| ID | Type | Description | Link |
|---|---|---|---|
| J2N-OX-JZNS | 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 assess the safety and tolerability of pirtobrutinib and to look at the amount of the study drug, pirtobrutinib, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. For each participant, the total duration of the study will be 46 days, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: 300 mg Pirtobrutinib | Experimental | Participants received a single dose of Pirtobrutinib 300 milligram (mg) administered orally on Day 1. |
|
| Cohort 2: 600 mg Pirtobrutinib | Experimental | Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1. |
|
| Cohort 3: 800 mg Pirtobrutinib | Experimental | Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1. |
|
| Cohort 4: 900 mg Pirtobrutinib | Experimental | Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirtobrutinib | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | TEAE is defined as an adverse event (AE) which starts on or after the first administration of study drug. A serious adverse event is defined as any AE occurring at any dose that results in any of the following outcomes: death; a life-threatening adverse drug experience; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacity; a congenital anomaly/birth defect; an important medical event that may require medical or surgical intervention to prevent any of the above outcomes. | Baseline up to 46 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib | PK: AUC0-24 of Pirtobrutinib. | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24 hours post-dose) |
| PK: Area Under the Concentration Versus Time Curve From Hour Zero to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib |
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Inclusion Criteria:
Exclusion Criteria:
History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
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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 | Cohort 1: 300 mg Pirtobrutinib | Participants received a single dose of Pirtobrutinib 300 milligram (mg) administered orally on Day 1. |
| FG001 | Cohort 2: 600 mg Pirtobrutinib | Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1. |
| FG002 | Cohort 3: 800 mg Pirtobrutinib | Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1. |
| FG003 | Cohort 4: 900 mg Pirtobrutinib | Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: 300 mg Pirtobrutinib | Participants received a single dose of Pirtobrutinib 300 mg administered orally on Day 1. |
| BG001 | Cohort 2: 600 mg Pirtobrutinib | Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1. |
| 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 | Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | TEAE is defined as an adverse event (AE) which starts on or after the first administration of study drug. A serious adverse event is defined as any AE occurring at any dose that results in any of the following outcomes: death; a life-threatening adverse drug experience; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacity; a congenital anomaly/birth defect; an important medical event that may require medical or surgical intervention to prevent any of the above outcomes. | All enrolled participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline up to 46 days |
|
Upto 46 days
All enrolled participants who received at least one dose of study drug.
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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 | Cohort 1: 300 mg Pirtobrutinib | Participants received a single dose of Pirtobrutinib 300 mg administered orally on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 23.0 | 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 | Aug 4, 2020 | Oct 10, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2020 | Oct 4, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000723100 | pirtobrutinib |
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|
PK: AUC0-t of Pirtobrutinib. |
| Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Pirtobrutinib | PK: AUC0-inf of Pirtobrutinib. | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
| PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib | PK: %AUCextrap of pirtobrutinib. | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
| PK: Maximum Observed Plasma Concentration (Cmax) of Pirtobrutinib | PK: Cmax of Pirtobrutinib. | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
| PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib | PK: Tmax of Pirtobrutinib. | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
| PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 1) | PK: λZ of Pirtobrutinib. | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
| PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 2) | PK: λZ of Pirtobrutinib. | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
| PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 3) | PK: λZ of Pirtobrutinib. | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
| PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 4) | PK: λZ of Pirtobrutinib. | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
| PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib | PK: CL/F of Pirtobrutinib. | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
| PK: Apparent Volume of Distribution at Terminal Phase (Vz/F) of Pirtobrutinib | PK: Vz/F of Pirtobrutinib. | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
| PK: Apparent Plasma Terminal Elimination Half-life (t1/2) of Pirtobrutinib | PK: t1/2 of Pirtobrutinib. | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
| BG002 | Cohort 3: 800 mg Pirtobrutinib | Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1. |
| BG003 | Cohort 4: 900 mg Pirtobrutinib | Participants received a single dose of Pirtobrutinib 900 mg administered orally 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 |
|
| OG001 | Cohort 2: 600 mg Pirtobrutinib | Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1. |
| OG002 | Cohort 3: 800 mg Pirtobrutinib | Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1. |
| OG003 | Cohort 4: 900 mg Pirtobrutinib | Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib | PK: AUC0-24 of Pirtobrutinib. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24 hours post-dose) |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve From Hour Zero to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib | PK: AUC0-t of Pirtobrutinib. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Pirtobrutinib | PK: AUC0-inf of Pirtobrutinib. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
|
|
|
| Secondary | PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib | PK: %AUCextrap of pirtobrutinib. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of AUCextrap | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
|
|
|
| Secondary | PK: Maximum Observed Plasma Concentration (Cmax) of Pirtobrutinib | PK: Cmax of Pirtobrutinib. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
|
|
|
| Secondary | PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib | PK: Tmax of Pirtobrutinib. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed. | Posted | Median | Full Range | hours | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
|
|
|
| Secondary | PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 1) | PK: λZ of Pirtobrutinib. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed. | Posted | Number | 1/hour (1/h) | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
|
|
|
| Secondary | PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 2) | PK: λZ of Pirtobrutinib. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed. | Posted | Number | 1/hour (1/h) | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
|
|
|
| Secondary | PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 3) | PK: λZ of Pirtobrutinib. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed. | Posted | Number | 1/hour (1/h) | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
|
|
|
| Secondary | PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 4) | PK: λZ of Pirtobrutinib. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed. | Posted | Number | 1/hour (1/h) | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
|
|
|
| Secondary | PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib | PK: CL/F of Pirtobrutinib. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter per hour (L/h) | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
|
|
|
| Secondary | PK: Apparent Volume of Distribution at Terminal Phase (Vz/F) of Pirtobrutinib | PK: Vz/F of Pirtobrutinib. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
|
|
|
| Secondary | PK: Apparent Plasma Terminal Elimination Half-life (t1/2) of Pirtobrutinib | PK: t1/2 of Pirtobrutinib. | All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Cohort 2: 600 mg Pirtobrutinib | Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Cohort 3: 800 mg Pirtobrutinib | Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Cohort 4: 900 mg Pirtobrutinib | Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1. | 0 | 6 | 0 | 6 | 3 | 6 |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
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| Subject 4 |
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| Subject 5 |
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| Subject 6 |
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| Title | Measurements |
|---|---|
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| Subject 4 |
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| Subject 5 |
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| Subject 6 |
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| Title | Measurements |
|---|---|
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| Subject 4 |
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| Subject 5 |
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| Subject 6 |
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| Title | Measurements |
|---|---|
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| Subject 4 |
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| Subject 5 |
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| Subject 6 |
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