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ItraconazoleWiki

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


Correlated Drug Terms (6)

Name (Synonyms) Correlation
drug1326 Lazertinib Wiki 0.71
drug86 ASTX660 Wiki 0.71
drug1490 Midazolam Wiki 0.71
drug2093 Rifampin Wiki 0.50
drug332 Best Practice Wiki 0.41
drug2527 Tocilizumab Wiki 0.13

Correlated MeSH Terms (8)

Name (Synonyms) Correlation
D003324 Coronary Artery Disease NIH 0.35
D007676 Kidney Failure, Chronic NIH 0.29
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.25
D008173 Lung Diseases, Obstructive NIH 0.24
D020521 Stroke NIH 0.22
D058186 Acute Kidney Injury NIH 0.17
D009369 Neoplasms, NIH 0.16
D007239 Infection NIH 0.04

Correlated HPO Terms (6)

Name (Synonyms) Correlation
HP:0001677 Coronary artery atherosclerosis HPO 0.35
HP:0006510 Chronic pulmonary obstruction HPO 0.25
HP:0006536 Pulmonary obstruction HPO 0.24
HP:0001297 Stroke HPO 0.22
HP:0001919 Acute kidney injury HPO 0.17
HP:0002664 Neoplasm HPO 0.16

There are 2 clinical trials

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)

2 A Two Cohort, Open-Label, Fixed Sequence Study to Investigate the Effect of CYP3A4 Inhibition on the Single Dose Pharmacokinetics of ASTX660 and the Effect of a Single Dose of ASTX660 on the Pharmacokinetics of the CYP3A4 Substrate Midazolam

In Part 1, the primary objective is to investigate the effect of multiple doses of itraconazole, an inhibitor of CYP3A4, on the pharmacokinetic (PK) profile of a single dose of ASTX660. In Part 2, the primary objective is to investigate the effect of a single dose of ASTX660 on the pharmacokinetics of the CYP3A4 substrate midazolam and its metabolite, 1-hydroxy midazolam. Safety and tolerability of a single dose of ASTX660 in the absence and presence of multiple doses of the CYP3A4 inhibitor itraconazole and in the presence of a single dose of the CYP3A4 substrate midazolam will also be evaluated.

NCT04411030 Healthy Volunteer Drug: ASTX660 Drug: Midazolam Drug: Itraconazole

Primary Outcomes

Description: Maximum plasma concentration

Measure: Pharmacokinetic parameter of ASTX660: Cmax

Time: From predose up to Day 14

Description: Area under the plasma concentration versus time curve from time zero to the last measurable concentration

Measure: Pharmacokinetic parameter of ASTX660: AUC0-t

Time: From predose up to Day 14

Description: Area under the plasma concentration versus time curve from time zero to 24 hours

Measure: Pharmacokinetic parameter of ASTX660: AUC0-24

Time: From predose up to Day 14

Description: Area under the plasma concentration versus time curve from time zero extrapolated to infinity

Measure: Pharmacokinetic parameter of ASTX660: AUC0-inf

Time: From predose up to Day 14

Description: Maximum plasma concentration

Measure: Pharmacokinetic parameter of midazolam and 1-hydroxyl midazolam: Cmax

Time: From predose up to Day 9

Description: Area under the plasma concentration versus time curve from time zero to the last measurable concentration

Measure: Pharmacokinetic parameter of midazolam and 1-hydroxyl midazolam: AUC0-t

Time: From predose up to Day 9

Description: Area under the plasma concentration versus time curve from time zero to 24 hours

Measure: Pharmacokinetic parameter of midazolam and 1-hydroxyl midazolam: AUC0-24

Time: From predose up to Day 9

Description: Area under the plasma concentration versus time curve from time zero extrapolated to infinity

Measure: Pharmacokinetic parameter of midazolam and 1-hydroxyl midazolam: AUC0-inf

Time: From predose up to Day 9

Secondary Outcomes

Description: Total apparent clearance

Measure: Pharmacokinetic parameter for ASTX660: CL/F

Time: From predose up to Day 14

Description: Observed terminal half-life

Measure: Pharmacokinetic parameter for ASTX660: t1/2

Time: From predose up to Day 14

Description: Total apparent clearance

Measure: Pharmacokinetic parameter for midazolam: CL/F

Time: From predose up to Day 9

Description: Observed terminal half-life

Measure: Pharmacokinetic parameter for midazolam: t1/2

Time: From predose up to Day 9

Measure: Safety: Number of participants with adverse events

Time: Up to Day 35

No related HPO nodes (Using clinical trials)