SGS Belgium NV
Edegem, 2650, Belgium
NCT Number: NCT05896683
The purpose of this study is to assess the extent of availability of drug to the body of four different lazertinib tablet formulations at a single oral dose under fasted conditions in healthy adult participants.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Edegem, 2650, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lazertinib will be administered orally.
Other names: JNJ-73841937
Time frame: Pre dose up to 168 hours post dose on Day 1
Cmax is defined as maximum observed plasma concentration of lazertinib.
Time frame: Pre dose up to 168 hours post dose on Day 1
Cmax is defined as maximum observed plasma concentration of lazertinib.
Time frame: Pre dose up to 72 hours post dose on Day 1
AUC(0-72h) is the area under the plasma concentration-time curve from time 0 to 72 hours.
Time frame: Pre dose up to 72 hours post dose on Day 1
AUC(0-72h) is the area under the plasma concentration-time curve from time 0 to 72 hours.
Time frame: Up to 8 Weeks
An 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 intervention.
Time frame: Up to 8 Weeks
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Up to 8 Weeks
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. Number of participants with AEs by severity will be reported. Severity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 to 5, where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
Time frame: Up to 8 Weeks
Number of participants with change from baseline in clinical laboratory test values (including hematology and serum chemistry) will be reported.
Time frame: Up to 8 Weeks
Number of participants with change from baseline in 12-lead ECGs will be reported.
Time frame: Up to 8 Weeks
Number of participants with change from baselines in vital signs (including temperature [oral], pulse rate, and blood pressure) will be reported.
Time frame: Up to 8 Weeks
Number of participants with change from baseline in physical examination (including height and body weight) will be reported.
Janssen Research & Development, LLC
Industry
A Phase 1, Open-label, Randomized, 2-Part, 2-Way Crossover Study in Healthy Adult Participants to Assess the Relative Bioavailability of Tablet Formulations of Lazertinib (JNJ-73841937)
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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