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NCT02058784 · ClinicalTrials.gov registry record · Early Phase 1

Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects

A Early Phase 1 study, sponsored by Helsinn Healthcare.

Completed
Registry status
Early Phase 1
Development phase
28
Enrollment target

NCT02058784: Completed Early Phase 1 study, sponsored by Helsinn Healthcare.

NCT02058784 is a Early Phase 1 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 28 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02058784, a Early Phase 1 study, has completed, sponsored by Helsinn Healthcare.

COMPLETED
Registry status
Early Phase 1
Development phase
28 participants
Enrollment target

Study Summary

Open label study of Pracinostat will be tested to assess the effect of food on the single-dose pharmacokinetics in healthy non-smoking and smoking adult subjects under fasted and fed conditions.

Primary Outcome

Assess the ratios of least square means of pracinostat plasma PK parameters AUC 0-t, AUC 0-inf and Cmax for pracinostat under fed versus fasted conditions

Interventions

  • DRUG pracinostat

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2014-02
Est. Completion 2014-03
Phase Early Phase 1
Helsinn Healthcare

18 total trials

What the finished NCT02058784 record still lists

NCT02058784 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 1 intervention - of which pracinostat is the first listed.

NCT02058784 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02058784 about?

NCT02058784 is a clinical study titled "Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects". Open label study of Pracinostat will be tested to assess the effect of food on the single-dose pharmacokinetics in healthy non-smoking and smoking adult subjects under fasted and fed conditions.

What is the current status of trial NCT02058784?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 28 participants. The study started on 2014-02. Estimated completion is 2014-03.

What interventions are being tested in trial NCT02058784?

The interventions under investigation include: pracinostat (DRUG).

Who is sponsoring clinical trial NCT02058784?

This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02058784's enrollment target sits among peer trials

28 938th of 2000 higher than 1,038 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early 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 NCT02058784, the US trial registry maintained by the National Library of Medicine. NCT02058784 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.