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NCT05140096 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Effect of Pharmacokinetics (PK) of Acalabrutinib and Its Active Metabolite (ACP-5862) When Administered Alone and With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole in Healthy Adult Participants

A Phase 1 study, sponsored by Acerta Pharma.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT05140096 is a Phase 1 study that has completed, run by Acerta Pharma. The registered enrollment target is 30 participants.

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The verdict

NCT05140096, a Phase 1 study, has completed, sponsored by Acerta Pharma.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

This study will evaluate the effect of fluconazole and isavuconazole on the PK of acalabrutinib and its active metabolite, ACP-5862.

Interventions

  • DRUG Fluconazole
  • DRUG Acalabrutinib
  • DRUG Isavuconazole

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2020-01-03
Est. Completion 2020-04-15
Phase Phase 1

Sponsor

Acerta Pharma

38 total trials

What the Registry Record Tells You About NCT05140096

The ClinicalTrials.gov registry entry for NCT05140096 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acerta Pharma, which has 38 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Fluconazole is the first listed.

NCT05140096 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05140096 about?

NCT05140096 is a clinical study titled "A Study to Evaluate the Effect of Pharmacokinetics (PK) of Acalabrutinib and Its Active Metabolite (ACP-5862) When Administered Alone and With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole in Healthy Adult Participants". This study will evaluate the effect of fluconazole and isavuconazole on the PK of acalabrutinib and its active metabolite, ACP-5862.

What is the current status of trial NCT05140096?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2020-01-03. Estimated completion is 2020-04-15.

What interventions are being tested in trial NCT05140096?

The interventions under investigation include: Fluconazole (DRUG), Acalabrutinib (DRUG), Isavuconazole (DRUG).

Who is sponsoring clinical trial NCT05140096?

This trial is sponsored by Acerta Pharma, which has 38 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.