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| ID | Type | Description | Link |
|---|---|---|---|
| J2N-MC-JZNW | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The main purpose of this study is to determine the effect of pirtobrutinib on the levels of rosuvastatin in the blood stream in healthy participants. This study will also evaluate the safety and tolerability of rosuvastatin when administered in combination with pirtobrutinib in healthy participants. This study will last up to approximately 26 days excluding screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin + Pirtobrutinib | Experimental | Participants received study intervention through oral administration as follows:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Administered Orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin | PK: Cmax of Rosuvastatin | Day 1, Day 6 and Day 13: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours (h) post-dose. |
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Rosuvastatin | PK: AUC(0-inf) of Rosuvastatin | Day 1, Day 6 and Day 13: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours (h) 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 |
|---|---|---|---|---|---|---|
| QPS Bio-Kinetic Clinical Applications | Springfield | Missouri | 65802 | United States | ||
| Covance Dallas |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rosuvastatin + Pirtobrutinib | Participants received study intervention through oral administration as follows:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rosuvastatin + Pirtobrutinib | Participants received study intervention through oral administration as follows:
|
| 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): Maximum Concentration (Cmax) of Rosuvastatin | PK: Cmax of Rosuvastatin | All randomized participants who received at least one dose of rosuvastatin and had evaluable PK data for the respective days for this outcome analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Day 1, Day 6 and Day 13: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours (h) post-dose. |
|
Baseline to end of follow-up (up to 24 days).
All participants from the safety population.
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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 | 20 mg Rosuvastatin (Day 1) | Participants received 20 milligram (mg) rosuvastatin alone on day 1 through oral administration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 24.1 | 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 | Dec 22, 2021 | May 6, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 22, 2021 | May 6, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| C000723100 | pirtobrutinib |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Pirtobrutinib |
| Drug |
Administered Orally. |
|
|
| Dallas |
| Texas |
| 75247 |
| United States |
| 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 |
|
|
|
| Primary | PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Rosuvastatin | PK: AUC(0-inf) of Rosuvastatin | All randomized participants who received at least one dose of rosuvastatin and had evaluable PK data for the respective days for this outcome analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours per milliliter(ng*h/mL) | Day 1, Day 6 and Day 13: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours (h) post-dose. |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 3 |
| 32 |
| EG001 | 20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 6) | Participants received 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib on day 6 through oral administration. | 0 | 32 | 0 | 32 | 1 | 32 |
| EG002 | 200 mg Pirtobrutinib QD (Days 7-12) | Participants received once daily (QD) doses of 200 mg pirtobrutinib alone on days 7 to 12 through oral administration. | 0 | 32 | 0 | 32 | 3 | 32 |
| EG003 | 20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 13) | Participants received 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib on day 13 through oral administration. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG004 | 200 mg Pirtobrutinib QD (Days 14-17) | Participants received QD doses of 200 mg pirtobrutinib alone on days 14 to 17 through oral administration. | 0 | 31 | 0 | 31 | 1 | 31 |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
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| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Day 13 |
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|