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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: Completed Phase 1 study, sponsored by Acerta Pharma.

NCT05140096 is a Phase 1 study that has completed, run by Acerta Pharma. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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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
Acerta Pharma

38 total trials

What the finished NCT05140096 record still lists

NCT05140096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

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

NCT05140096 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT05140096's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 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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Source: ClinicalTrials.gov NCT05140096, the US trial registry maintained by the National Library of Medicine. NCT05140096 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.