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NCT05395117 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Effect of AZD5462 on the Pharmacokinetics of Midazolam, Rosuvastatin and Digoxin
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT05395117 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 32 participants.
The verdict
NCT05395117, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study will assess the effect of multiple doses of AZD5462 on the PK of oral midazolam (CYP3A4 probe), rosuvastatin (OATP1B1/3, BCRP probe), and digoxin (P-gp probe) in healthy participants. This study will consist of 2 treatment arms (Treatment Arms A and B) and within each treatment arm, the participants will first be administered the probe substrates (midazolam, rosuvastatin, and digoxin) alone followed by administration of the probe substrates together with AZD5462. The treatment arms differ in the dose of AZD5462 being administered and will be performed sequentially starting with Treatment Arm A (AZD5462 Dose A, high dose treatment arm) and followed by Treatment Arm B (AZD5462 Dose B, low dose treatment arm). Each treatment arm will include 5 periods. Thirty two participants in total (16 participants per treatment arm) will be enrolled to ensure at least 24 evaluable participants (12 participants per treatment arm) at the end of the last treatment period. A follow-up visit at Day 24 (+-1 Day) will be conducted via a phone call.
Interventions
- DRUG Midazolam
- DRUG Rosuvastatin
- DRUG Digoxin
- DRUG AZD5462
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2022-06-30 |
| Est. Completion | 2022-09-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05395117
The ClinicalTrials.gov registry entry for NCT05395117 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Midazolam is the first listed.
NCT05395117 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05395117 about?
NCT05395117 is a clinical study titled "A Study to Assess the Effect of AZD5462 on the Pharmacokinetics of Midazolam, Rosuvastatin and Digoxin". This study will assess the effect of multiple doses of AZD5462 on the PK of oral midazolam (CYP3A4 probe), rosuvastatin (OATP1B1/3, BCRP probe), and digoxin (P-gp probe) in healthy participants. This study will consist of 2 treatment arms (Treatment Arms A and B) and within each treatment arm, the ...
What is the current status of trial NCT05395117?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2022-06-30. Estimated completion is 2022-09-12.
What interventions are being tested in trial NCT05395117?
The interventions under investigation include: Midazolam (DRUG), Rosuvastatin (DRUG), Digoxin (DRUG), AZD5462 (DRUG).
Who is sponsoring clinical trial NCT05395117?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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