CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

LazertinibWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug714 Itraconazole Wiki 0.71
drug1160 Rifampin Wiki 0.71
drug1035 Placebo oral tablet Wiki 0.20
drug591 Hydroxychloroquine Wiki 0.11

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D045169 Severe Acute Respiratory Syndrome NIH 0.06
D018352 Coronavirus Infections NIH 0.05

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Phase 1 Open-Label, Fixed-Sequence Drug-Drug Interaction Study to Evaluate the Effects of Steady-state Itraconazole and Rifampin on the Single-dose Pharmacokinetics of Lazertinib Tablets in Healthy Adult Participants

The purpose of this study is to evaluate the effects of multiple doses of strong cytochrome P450 (CYP) 3A4 inhibitor itraconazole and strong CYP3A4 inducer rifampin on the single dose pharmacokinetics (PK) of lazertinib in healthy adult participants.

NCT04410094 Healthy Drug: Lazertinib Drug: Itraconazole Drug: Rifampin

Primary Outcomes

Description: Cmax is defined as maximum plasma concentration.

Measure: Cohort 1 and 2: Maximum Plasma Concentration (Cmax) of Lazertinib

Time: Predose up to 120 hours post dose

Description: AUC (0-120h) is defined as area under the plasma concentration-time curve from time 0 to 120 hours postdose.

Measure: Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time 0 to 120 Hours (AUC [0-120h]) of Lazertinib

Time: Predose up to 120 hours post dose

Description: AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable timepoint.

Measure: Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Timepoint (AUC [0-last]) of Lazertinib

Time: Predose up to 120 hours post dose

Description: AUC (0-inf) is defined as area under the plasma concentration-time curve from time 0 to infinity, calculated as the sum of AUC(0-last)+C(last)/ lambda(z), where C(last) is the last observed measurable (non-below limit of quantification) concentration.

Measure: Cohort 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-inf]) of Lazertinib

Time: Predose up to 120 hours post dose

Description: %AUC (0-inf),ex is defined as percentage of area under the plasma concentration from time zero to infinite time obtained by extrapolation, calculated as (AUC [0-infinity] minus AUC [0-last]/AUC [0-infinity])*100.

Measure: Cohort 1 and 2: Percentage of Area Under the Plasma Concentration from time Zero to Infinite time obtained by Extrapolation (%AUC [0-inf],ex) of Lazertinib

Time: Predose up to 120 hours post dose

Secondary Outcomes

Description: An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.

Measure: Cohort 1 and Cohort 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Time: Up to 65 days (Cohort 1) and up to 70 days (Cohort 2)

No related HPO nodes (Using clinical trials)