PRA Health Sciences
Salt Lake City, Utah, 84124, United States
NCT Number: NCT05076877
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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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Salt Lake City, Utah, 84124, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lazertinib tablets will be administered orally, alone or in combination with probe substrates.
Other names: JNJ-73841937, YH25448
Midazolam (cytochrome P450 3A4 [CYP3A4] substrate) will be administered orally as a syrup as a part of probe substrates.
Rosuvastatin (breast cancer resistant protein [BCRP] substrate) tablet will be administered orally as a part of probe substrates.
Metformin (organic cation transporter 1 [OCT1] substrate) will be administered orally as a syrup as a part of probe substrates.
Time frame: Predose up to 12 hours postdose (Days 1 and 13)
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.
Time frame: Up to 56 days
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.
Time frame: Up to 56 days
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.
Time frame: Up to 28 days
Number of participants with change in clinical laboratory test results (including hematology and serum chemistry) will be reported.
Time frame: Up to 28 days
Number of participants with clinically significant abnormalities in ECGs will be reported.
Time frame: Up to 28 days
Number of participants with clinically significant abnormalities in vital signs (including temperature [oral], pulse rate, and blood pressure) will be reported.
Time frame: Up to 28 days
Number of participants with clinically significant abnormalities in physical examination (including height and body weight) will be reported.
Time frame: Predose on Day 7, 9, 11, 13, and 14
Plasma concentration of lazertinib at steady-state will be assessed.
Time frame: Day 14, 15, 16, 17, 21, and 28
Plasma concentration of lazertinib following repeat dosing for 10 days will be assessed.
Janssen Research & Development, LLC
Industry
A Phase 1, Open-label, Study in Healthy Participants to Evaluate the Effect of Steady State Concentrations of Lazertinib (JNJ-73841937) on the Single-dose Pharmacokinetics of Probe Substrates (Midazolam, Rosuvastatin, and Metformin)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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