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NCT04411030 · ClinicalTrials.gov registry record · Phase 1
A 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
A Phase 1 study, sponsored by Astex Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT04411030 is a Phase 1 study that has completed, run by Astex Pharmaceuticals. The registered enrollment target is 36 participants.
The verdict
NCT04411030, a Phase 1 study, has completed, sponsored by Astex Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Midazolam
- DRUG Itraconazole
- DRUG ASTX660
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-05-20 |
| Est. Completion | 2020-08-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04411030
The ClinicalTrials.gov registry entry for NCT04411030 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astex Pharmaceuticals, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.
NCT04411030 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04411030 about?
NCT04411030 is a clinical study titled "A 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...
What is the current status of trial NCT04411030?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2020-05-20. Estimated completion is 2020-08-29.
What interventions are being tested in trial NCT04411030?
The interventions under investigation include: Midazolam (DRUG), Itraconazole (DRUG), ASTX660 (DRUG).
Who is sponsoring clinical trial NCT04411030?
This trial is sponsored by Astex Pharmaceuticals, which has 38 total clinical trials registered on ClinicalTrials.gov.
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