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NCT02088398 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy, sponsored by Acetylon Pharmaceuticals Incorporated.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target
1
Study location

NCT02088398: Completed Phase 1 study of Healthy, sponsored by Acetylon Pharmaceuticals Incorporated.

NCT02088398 is a Phase 1 study of Healthy that has completed, run by Acetylon Pharmaceuticals Incorporated. The registered enrollment target is 19 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02088398, a Phase 1 study of Healthy, has completed, sponsored by Acetylon Pharmaceuticals Incorporated.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target
1
Study location

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 Studied

Interventions

  • DRUG ACY-1215

Study Locations (1)

Wisconsin

  • Covance Clinical Research Unit Incorporated - Madison

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2014-03
Est. Completion 2014-04
Phase Phase 1

What the Registry Record Tells You About NCT02088398

The ClinicalTrials.gov registry entry for NCT02088398 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The listed sponsor is Acetylon Pharmaceuticals Incorporated, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which ACY-1215 is the first listed.

NCT02088398 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT02088398 about?

NCT02088398 is a clinical study titled "Alternative 10 mg/mL Liquid Formulation of ACY 1215 (Ricolinostat) in Healthy Subjects". 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 Treatmen...

What is the current status of trial NCT02088398?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2014-03. Estimated completion is 2014-04.

What conditions does trial NCT02088398 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT02088398?

The interventions under investigation include: ACY-1215 (DRUG).

Who is sponsoring clinical trial NCT02088398?

This trial is sponsored by Acetylon Pharmaceuticals Incorporated, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02088398 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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, the data changelog, or report a data error.