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

NCT02058784 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-02-23

No results posted yet for this 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.

Conditions

  • Healthy Volunteers
  • Moderate to Heavy Smokers
  • Non-smokers

Interventions

DRUG

pracinostat

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY
  • Helsinn Healthcare SA

    lead INDUSTRY

Principal Investigators

  • Terry E O'Reilly, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02058784 on ClinicalTrials.gov