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| ID | Type | Description | Link |
|---|---|---|---|
| J2N-OX-JZNH | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to learn about how food and a PPI (omeprazole) affect LOXO-305 in healthy participants. Participation could last about nine weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1: ABC | Experimental |
A washout period of 7 days was maintained between each treatment period. |
|
| Treatment Sequence 2: BAC | Experimental |
A washout period of 7 days was maintained between each treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOXO-305 | Drug | LOXO-305 orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration-time Curve From Hour 0 to 24 (AUC [0-24]) Hours of LOXO-305 | PK: AUC(0-24) hours of LOXO-305 is reported. AUC(0-24) was calculated by the linear trapezoidal method. | Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post LOXO-305 dose |
| PK: Area Under the Concentration-time Curve From Hour 0 to the Last Measurable Concentration (AUC[0-t]) of LOXO-305 | PK: AUC(0-t) of LOXO-305 is reported. AUC(0-t) was calculated by linear trapezoidal method. | Predose, 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 LOXO-305 dose |
| PK: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC[0-Inf]) of LOXO-305 | PK: AUC(0-inf) of LOXO-305 is reported. AUC(0-inf) was calculated using the formula: AUC(0-inf) = AUC(0-t) + Ct/λZ; where Ct is the last measurable concentration and λZ is the apparent terminal elimination rate constant. | Predose, 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 LOXO-305 dose |
| PK: Percentage Extrapolation for AUC0-Inf (%AUCextrap) of LOXO-305 | PK: %AUCextrap of LOXO-305 is reported. | Predose, 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 LOXO-305 dose |
| PK: Maximum Observed Plasma Concentration (Cmax) of LOXO-305 | PK: Cmax of LOXO-305 is reported. | Predose, 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 LOXO-305 dose |
| PK: Time to Maximum Observed Plasma Concentration (Tmax) of LOXO-305 |
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Inclusion Criteria:
Exclusion Criteria:
History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
Participants with out-of-range, at-rest vital signs.
Abnormal laboratory values determined to be clinically significant by the Investigator (or designee), and Sponsor.
Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) through the end of the trial.
History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
Receipt of blood products within 2 months prior to Check-in (Day -1).
Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), GI, neurological, or psychiatric disorder (as determined by the Investigator), or cancer within the past 5 years (except localized basal cell, squamous, or in situ cancer of the skin).
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| Name | Affiliation | Role |
|---|---|---|
| Renée 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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Participants were randomized to 2 treatment sequences (ABC and BAC), with each sequence having 3 periods where participants were crossed over between the periods in each sequence. A washout period of 7 days was maintained between each treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1: ABC |
A washout period of 7 days was maintained between each treatment period. |
| FG001 | Treatment Sequence 2: BAC |
A washout period of 7 days was maintained between each treatment period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Period 2 |
| ||||||||||||||||
| Period 3 |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1: ABC |
A washout period of 7 days was maintained between each treatment period. |
| 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 Hour 0 to 24 (AUC [0-24]) Hours of LOXO-305 | PK: AUC(0-24) hours of LOXO-305 is reported. AUC(0-24) was calculated by the linear trapezoidal method. | All participants who received at least one dose of LOXO-305 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanograms per milliliter | Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post LOXO-305 dose |
|
Day 1 up to Day 32
All participants who received at least 1 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 | Treatment A: 200 mg LOXO-305 (Fasted) | All the participants who received single oral dose of 200 mg LOXO-305 in fasted state on Day 1 (sequence 1), Day 8 (sequence 2). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | 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 | Jan 29, 2020 | Jun 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 21, 2020 | Jun 25, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000723100 | pirtobrutinib |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Omeprazole |
| Drug |
Omeprazole Orally. |
|
PK: tmax of LOXO-305 is reported. |
| Predose, 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 LOXO-305 dose |
| PK: Apparent Terminal Elimination Half-life (t½) of LOXO-305 | PK: t½ of LOXO-305 is reported. | Predose, 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 LOXO-305 dose |
| PK: Apparent Systemic Clearance (CL/F) of LOXO-305 | PK: CL/F of LOXO-305 is reported. | Predose, 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 LOXO-305 dose |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Treatment Sequence 2: BAC |
A washout period of 7 days was maintained between each treatment period. |
| BG002 | 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 |
|
All the participants who received single oral dose of 200 mg LOXO-305 in fed state on Day 1 (sequence 2), Day 8 (sequence 1). |
| OG002 | Treatment C: 200 mg LOXO-305 + 40 mg Omeprazole (Fasted) | All participants in sequence 1 and 2 who received single oral dose of 40 mg Omeprazole in fasted state on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole in fasted state on Day 18. |
|
|
| Primary | PK: Area Under the Concentration-time Curve From Hour 0 to the Last Measurable Concentration (AUC[0-t]) of LOXO-305 | PK: AUC(0-t) of LOXO-305 is reported. AUC(0-t) was calculated by linear trapezoidal method. | All participants who received at least one dose of LOXO-305 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanograms per milliliter | Predose, 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 LOXO-305 dose |
|
|
|
| Primary | PK: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC[0-Inf]) of LOXO-305 | PK: AUC(0-inf) of LOXO-305 is reported. AUC(0-inf) was calculated using the formula: AUC(0-inf) = AUC(0-t) + Ct/λZ; where Ct is the last measurable concentration and λZ is the apparent terminal elimination rate constant. | All participants who received at least one dose of LOXO-305 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanograms per milliliter | Predose, 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 LOXO-305 dose |
|
|
|
| Primary | PK: Percentage Extrapolation for AUC0-Inf (%AUCextrap) of LOXO-305 | PK: %AUCextrap of LOXO-305 is reported. | All participants who received at least one dose of LOXO-305 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of extrapolation | Predose, 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 LOXO-305 dose |
|
|
|
| Primary | PK: Maximum Observed Plasma Concentration (Cmax) of LOXO-305 | PK: Cmax of LOXO-305 is reported. | All participants who received at least one dose of LOXO-305 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | Predose, 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 LOXO-305 dose |
|
|
|
| Primary | PK: Time to Maximum Observed Plasma Concentration (Tmax) of LOXO-305 | PK: tmax of LOXO-305 is reported. | All participants who received at least one dose of LOXO-305 and had evaluable PK data. | Posted | Median | Full Range | hours | Predose, 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 LOXO-305 dose |
|
|
|
| Primary | PK: Apparent Terminal Elimination Half-life (t½) of LOXO-305 | PK: t½ of LOXO-305 is reported. | All participants who received at least one dose of LOXO-305 and had evaluable PK data. | Posted | Mean | Standard Deviation | hours | Predose, 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 LOXO-305 dose |
|
|
|
| Primary | PK: Apparent Systemic Clearance (CL/F) of LOXO-305 | PK: CL/F of LOXO-305 is reported. | All participants who received at least one dose of LOXO-305 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per Hours (L/h) | Predose, 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 LOXO-305 dose |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Treatment B: 200 mg LOXO-305 (Fed) | All the participants who received single oral dose of 200 mg LOXO-305 in fed state on Day 1 (sequence 2), Day 8 (sequence 1). | 0 | 10 | 0 | 10 | 1 | 10 |
| EG002 | Treatment C: 200 mg LOXO-305 + 40 mg Omeprazole (Fasted) | All participants in sequence 1 and 2 who received single oral dose of 40 mg Omeprazole in fasted state on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole in fasted state on Day 18. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Treatment C: 40 mg Omeprazole (Fasted) | All participants who received single oral dose of 40 mg Omeprazole (Fasted) on Day 15 to 17. | 0 | 10 | 0 | 10 | 0 | 10 |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.1 | 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 |