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Alternative 10 mg/mL Liquid Formulation of ACY 1215 (Ricolinostat) in Healthy Subjects

NCT02088398 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2014-09-11

No results posted yet for this study

Summary

This study will be an open-label, randomized, single dose, 3-period crossover PK study. This study will comprise 3 treatment periods with a 4-day washout between periods. On Day -1, subjects will be randomized to 1 of 6 treatment sequences. On Days 1, 5, and 9, subjects will be administered Treatment A, B, or C according to the randomization schedule.

* Treatment A: a single dose of 160 mg ACY-1215 CLF (20 mg/mL) in the fed state
* Treatment B: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fed state
* Treatment C: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fasted state

Conditions

  • Healthy

Interventions

DRUG

ACY-1215

Sponsors & Collaborators

  • Acetylon Pharmaceuticals Incorporated

    lead INDUSTRY

Principal Investigators

  • Nicholas Siebers, M.D. · Covance

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-04-30
Completion
2014-04-30

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 NCT02088398 on ClinicalTrials.gov