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| ID | Type | Description | Link |
|---|---|---|---|
| J2N-OX-JZNL | 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 evaluate the effect of pirtobrutinib (LOXO-305) on single oral dose of repaglinide (CYP2C8 substrate) when administered as multiple doses by conducting the blood tests to measure how much pirtobrutinib (LOXO-305) is in the bloodstream and how the body handles and eliminates pirtobrutinib (LOXO-305) in adult healthy participants. The study will also evaluate the safety and tolerability of pirtobrutinib (LOXO-305). The study is conducted in two periods. Participants will stay in this study for up to 54 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: 0.5 mg Repaglinide | Experimental | Participants received a single oral dose of 0.5 milligrams (mg) repaglinide tablet, in the morning on Day 1. |
|
| Period 2: 200 mg Pirtobrutinib QD | Experimental | Participants received oral doses of 200 mg pirtobrutinib tablets, once daily (QD) in the morning from Day 2 to Day 11. |
|
| Period 2: 200 mg Pirtobrutinib QD + 0.5 mg Repaglinide | Experimental | Participants received oral doses of 200 mg pirtobrutinib QD and 0.5 mg repaglinide tablets, in the morning on Day 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repaglinide | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Repaglinide | PK: AUC(0-t) of repaglinide was reported. | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
| PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Repaglinide | PK: AUC(0-inf) of repaglinide was reported. | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
| PK: Percentage of AUC0-inf Extrapolated (AUC%Extrap) of Repaglinide | PK: AUC-inf (%extrap) of repaglinide was reported. | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
| PK: Maximum Observed Concentration (Cmax) of Repaglinide | PK: Cmax of repaglinide was reported. | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
| PK: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Repaglinide | PK: Tmax of repaglinide was reported. | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
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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 | Daytona Beach | Florida | 32117 | United States |
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A total of 16 participants were enrolled in two period. In Period 1, participants received repaglinide only and in Period 2, participants received pirtobrutinib only followed by pirtobrutinib + repaglinide.
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| ID | Title | Description |
|---|---|---|
| FG000 | Period 1: 0.5 mg Repaglinide | Participants received a single oral dose of 0.5 milligrams (mg) repaglinide tablet, in the morning on Day 1. |
| FG001 | Period 2: 200 mg Pirtobrutinib QD | Participants received oral doses of 200 mg pirtobrutinib tablets, once daily (QD) in the morning from Day 2 to Day 11. |
| FG002 | Period 2: 200 mg Pirtobrutinib QD + 0.5 mg Repaglinide | Participants received oral doses of 200 mg pirtobrutinib QD and 0.5 mg repaglinide tablets, in the morning on Day 12. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Day 1) |
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| Washout Period (11 Days) |
| |||||||||||||
| Period 2 (Day 2 to 11) |
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| Period 2 (Day 12) |
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All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Period 1: 0.5 mg Repaglinide | Participants received a single oral dose of 0.5 mg repaglinide tablet, in the morning 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 | Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Repaglinide | PK: AUC(0-t) of repaglinide was reported. | The PK Population included all participants who received a dose of Repaglinide, 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) | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
|
Baseline up to 23 days
All participants who received at least 1 dose of study drug (repaglinide and/or 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 | Period 1: 0.5 mg Repaglinide | Participants received a single oral dose of 0.5 mg repaglinide tablet, in the morning on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal 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 | Oct 7, 2020 | Jan 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 18, 2020 | Jan 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C072379 | repaglinide |
| C000723100 | pirtobrutinib |
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| Pirtobrutinib | Drug | Administered orally. |
|
|
| PK: Apparent Terminal Elimination Rate Constant (Lambda Z) of Repaglinide | PK: Lambda Z of repaglinide was reported. | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
| PK: Apparent Systemic Clearance (CL/F) of Repaglinide | PK: CL/F of repaglinide was reported. | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
| PK: Apparent Plasma Terminal Elimination Half-life (t½) of Repaglinide | PK: t½ of repaglinide was reported. | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
| PK: Apparent Volume of Distribution (Vz/F) of Repaglinide | PK: Vz/F of repaglinide was reported. | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
| 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. | Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 42, 78 and 100 hours post-dose) |
| PK: Area Under the Concentration-time Curve During a Dosing Interval (AUCtau) of Pirtobrutinib | PK: AUCtau of pirtobrutinib was reported. | Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 42, 78 and 100 hours post-dose) |
| PK: Maximum Observed Concentration (Cmax) of Pirtobrutinib | PK: Cmax of pirtobrutinib was reported. | Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 42, 78 and 100 hours post-dose) |
| PK: Concentration Observed at the End of the Dosing Interval (Ctrough) of Pirtobrutinib | PK: Ctrough of pirtobrutinib was reported. | Period 2: 24-hour post-dose on Day 12 |
| PK: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib | PK: Tmax of pirtobrutinib was reported. | Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 42, 78 and 100 hours post-dose) |
| PK: Apparent Systemic Clearance (CL/F) at Steady State of Pirtobrutinib | PK: CL/F at steady state of pirtobrutinib was reported. | Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 42, 78 and 100 hours post-dose) |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
|
| years |
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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 |
|
| OG001 | Period 2: 200 mg Pirtobrutinib QD + 0.5 mg Repaglinide | Participants received oral doses of 200 mg pirtobrutinib QD and 0.5 mg repaglinide tablets, in the morning on Day 12. |
|
|
| Primary | PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Repaglinide | PK: AUC(0-inf) of repaglinide was reported. | The PK Population included all participants who received a dose of Repaglinide, 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 | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
|
|
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| Primary | PK: Percentage of AUC0-inf Extrapolated (AUC%Extrap) of Repaglinide | PK: AUC-inf (%extrap) of repaglinide was reported. | The PK Population included all participants who received a dose of Repaglinide, 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 AUC0-inf extrapolated | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
|
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| Primary | PK: Maximum Observed Concentration (Cmax) of Repaglinide | PK: Cmax of repaglinide was reported. | The PK Population included all participants who received a dose of Repaglinide, 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) | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
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| Primary | PK: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Repaglinide | PK: Tmax of repaglinide was reported. | The PK Population included all participants who received a dose of Repaglinide, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed. | Posted | Median | Full Range | hour | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
|
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| Primary | PK: Apparent Terminal Elimination Rate Constant (Lambda Z) of Repaglinide | PK: Lambda Z of repaglinide was reported. | The PK Population included all participants who received a dose of Repaglinide, had at least 1 quantifiable plasma concentration, and for whom at least 1 PK parameter was computed. | Posted | Number | one per hour (1/h) | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
|
|
|
| Primary | PK: Apparent Systemic Clearance (CL/F) of Repaglinide | PK: CL/F of repaglinide was reported. | The PK Population included all participants who received a dose of Repaglinide, 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) | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
|
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| Primary | PK: Apparent Plasma Terminal Elimination Half-life (t½) of Repaglinide | PK: t½ of repaglinide was reported. | The PK Population included all participants who received a dose of Repaglinide, 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 | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
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| Primary | PK: Apparent Volume of Distribution (Vz/F) of Repaglinide | PK: Vz/F of repaglinide was reported. | The PK Population included all participants who received a dose of Repaglinide, 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 | Period 1, Day 1 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose); Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16 and 24 hours post-dose) |
|
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| 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 included all participants who received a 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 | Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 42, 78 and 100 hours post-dose) |
|
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| Primary | PK: Area Under the Concentration-time Curve During a Dosing Interval (AUCtau) of Pirtobrutinib | PK: AUCtau of pirtobrutinib was reported. | The PK Population included all participants who received a 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 | Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 42, 78 and 100 hours post-dose) |
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| Primary | PK: Maximum Observed Concentration (Cmax) of Pirtobrutinib | PK: Cmax of pirtobrutinib was reported. | The PK Population included all participants who received a 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 | ng/mL | Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 42, 78 and 100 hours post-dose) |
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| Primary | PK: Concentration Observed at the End of the Dosing Interval (Ctrough) of Pirtobrutinib | PK: Ctrough of pirtobrutinib was reported. | The PK Population included all participants who received a 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 | ng/mL | Period 2: 24-hour post-dose on Day 12 |
|
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| Primary | PK: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib | PK: Tmax of pirtobrutinib was reported. | The PK Population included all participants who received a 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 | Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 42, 78 and 100 hours post-dose) |
|
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| Primary | PK: Apparent Systemic Clearance (CL/F) at Steady State of Pirtobrutinib | PK: CL/F at steady state of pirtobrutinib was reported. | The PK Population included all participants who received a 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) | Period 2, Day 12 (Pre-dose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 42, 78 and 100 hours post-dose) |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | Period 2: 200 mg Pirtobrutinib QD | Participants received oral doses of 200 mg pirtobrutinib tablets, QD in the morning from Day 2 to Day 11. | 0 | 16 | 0 | 16 | 6 | 16 |
| EG002 | Period 2: 200 mg Pirtobrutinib QD + 0.5 mg Repaglinide | Participants received oral doses of 200 mg pirtobrutinib QD and 0.5 mg repaglinide tablets, in the morning on Day 12. | 0 | 16 | 0 | 16 | 1 | 16 |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue 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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Not provided
| Participant 2 |
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| Participant 3 |
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| Participant 4 |
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| Participant 5 |
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| Participant 6 |
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| Participant 7 |
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| Participant 8 |
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| Participant 9 |
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| Participant 10 |
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| Participant 11 |
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| Participant 12 |
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| Participant 13 |
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| Participant 14 |
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| Participant 15 |
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| Participant 16 |
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