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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: Completed Phase 1 study, sponsored by Astex Pharmaceuticals.
NCT04411030 is a Phase 1 study that has completed, run by Astex Pharmaceuticals. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Maximum plasma concentration
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 |
What the finished NCT04411030 record still lists
NCT04411030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.
NCT04411030 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04411030's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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