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MidazolamWiki

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


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug86 ASTX660 Wiki 1.00
drug1269 Itraconazole Wiki 0.71

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D058186 Acute Kidney Injury NIH 0.24

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0001919 Acute kidney injury HPO 0.24

There is one clinical trial.

Clinical Trials

1 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)