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| ID | Type | Description | Link |
|---|---|---|---|
| 73841937NSC1008 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the effect of steady-state concentrations of lazertinib on the single-dose pharmacokinetics (PK) of probe substrates (midazolam, rosuvastatin, and metformin) in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lazertinib + Probe Substrates of Midazolam, Rosuvastatin, and Metformin | Experimental | Participants will receive a single oral dose of probe substrates of midazolam, rosuvastatin, and metformin on Day 1 under fasted conditions followed by a single oral dose of lazertinib under fed conditions from Day 5 to Day 14 except Day 13 which is under fasted conditions and co-administered with probe substrates under fasted conditions on Day 13. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lazertinib | Drug | Lazertinib tablets will be administered orally, alone or in combination with probe substrates. |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Probe Substrates (Midazolam, Rosuvastatin, and Metformin) Co-administered with Lazertinib (Day 13) as Test Versus Plasma Concentration of Probe Substrates Administered Alone (Day 1) as Reference | Plasma samples will be analyzed to determine concentrations of midazolam and its metabolite 1-OH-midazolam, rosuvastatin, metformin, or lazertinib using a validated, specific, and sensitive method on Day 1 versus Day 13 as a part of drug-drug interaction (DDI) assessment. | Predose up to 12 hours postdose (Days 1 and 13) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | Up to 56 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Salt Lake City | Utah | 84124 | United States |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| C000707992 | lazertinib |
| D008874 | Midazolam |
| D000068718 | Rosuvastatin Calcium |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam | Drug | Midazolam (cytochrome P450 3A4 [CYP3A4] substrate) will be administered orally as a syrup as a part of probe substrates. |
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| Rosuvastatin | Drug | Rosuvastatin (breast cancer resistant protein [BCRP] substrate) tablet will be administered orally as a part of probe substrates. |
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| Metformin | Drug | Metformin (organic cation transporter 1 [OCT1] substrate) will be administered orally as a syrup as a part of probe substrates. |
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| Number of Participants with AEs by Severity |
Number of participants with AEs by severity will be reported. AE severity is a clinical determination of the intensity of an AE and is assessed by using the standard grades as follows: Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to AE. |
| Up to 56 days |
| Number of Participants with Clinically Significant Changes in Laboratory Test Results | Number of participants with change in clinical laboratory test results (including hematology and serum chemistry) will be reported. | Up to 28 days |
| Number of Participants with Clinically Significant Abnormalities in 12-lead Electrocardiograms (ECGs) | Number of participants with clinically significant abnormalities in ECGs will be reported. | Up to 28 days |
| Number of Participants with Clinically Significant Abnormalities in Vital Signs | Number of participants with clinically significant abnormalities in vital signs (including temperature [oral], pulse rate, and blood pressure) will be reported. | Up to 28 days |
| Number of Participants with Clinically Significant Abnormalities in Physical Examination | Number of participants with clinically significant abnormalities in physical examination (including height and body weight) will be reported. | Up to 28 days |
| Plasma Concentrations of Lazertinib at steady-state | Plasma concentration of lazertinib at steady-state will be assessed. | Predose on Day 7, 9, 11, 13, and 14 |
| Plasma Concentrations of Lazertinib Following Repeat Dosing for 10 Days | Plasma concentration of lazertinib following repeat dosing for 10 days will be assessed. | Day 14, 15, 16, 17, 21, and 28 |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |