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

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ClinicalTrials.gov Identifier: NCT02088398
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):
Acetylon Pharmaceuticals Incorporated

Brief 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

Condition or disease Intervention/treatment Phase
Healthy Drug: ACY-1215 Phase 1

Detailed Description:
Subjects will be confined to the Clinical Research Unit (CRU) from the time of Check-in (Day -1) to Day 10. Predose blood and urine samples will be obtained prior to each ACY-1215 administration. Following administration of ACY-1215 in each period, blood and urine samples will be collected at specified timepoints or intervals through 24 hours postdose for the determination of the PK of a single oral dose of ACY-1215. Subjects will be discharged from the CRU on Day 10, following the completion of the last PK collection and successful completion and evaluation of discharge safety tests. Subjects will return to the clinic for a Follow-up visit 5 to 7 days after the last dose of ACY-1215 (Days 14 to 16) for additional safety evaluations.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Open-Label, Randomized, Single Dose, 3-Period Crossover to Evaluate the Relative Bioavailability and Food-Effect on Pharmacokinetics of Alternative 10 mg/mL Liquid Formulation ACY-1215 (Ricolinostat) in Healthy Subjects
Study Start Date : March 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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



Primary Outcome Measures :
  1. Area Under the Curve From Zero to Last Time - AUC0-last [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose ]

Secondary Outcome Measures :
  1. Safety and tolerability parameters [ Time Frame: Day 1 (first dose of ACY-1215) to Day 16 ]
    Changes from baseline in clinical laboratory assessments, vital signs, electrocardiogram values, and physical exam. This includes collection of adverse events and the collection of concomitant medications.

  2. Area Under the Curve From Time Zero to Extrapolated Infinite Time [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose ]
  3. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose ]
  4. Plasma Decay Half-Life [ Time Frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 65 years of age, inclusive
  • BMI range 18.5 to 32.0 kg/m2
  • in good health, as determined by no clinically significant findings from medical history, 12-lead ECG, vital signs
  • clinical laboratory evaluations, CBC, coagulation, and UA
  • negative test for selected drugs of abuse
  • negative hepatitis panel and negative HIV antibody
  • females of non-childbearing potential as outlined in protocol
  • males either be sterile or agree to use contraception as outlined in protocol

Exclusion Criteria:

  • significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
  • history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
  • history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
  • history of Gilbert's Syndrome or suspicion of Gilbert's Syndrome
  • abnormality in the 12-lead ECG (e.g. QTcF of >450 msec, a history of a prolonged QTc-interval or Brugada syndrome)
  • history of alcoholism or drug addiction within 1 year prior
  • participation in any other investigational study drug trial in which receipt of an investigational study drug as outlined in protocol
  • use of any prescription medications/products within 14 days (30 days for cytochrome P450 [CYP]-inducing or inhibiting products as outlined in protocol)
  • use of any over-the-counter, nonprescription preparations within 14 days
  • use of any tobacco or nicotine-containing products within 6 months and during study;
  • poor peripheral venous access
  • donation of blood from 30 days prior to Screening through the Follow-up visit
  • any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088398


Locations
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United States, Wisconsin
Covance Clinical Research Unit Incorporated
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Acetylon Pharmaceuticals Incorporated
Investigators
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Principal Investigator: Nicholas Siebers, M.D. Covance

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Responsible Party: Acetylon Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT02088398     History of Changes
Other Study ID Numbers: ACE-HV-100
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014
Keywords provided by Acetylon Pharmaceuticals Incorporated:
relative bioavailability
food-effect
Additional relevant MeSH terms:
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Ricolinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action