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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

Tracking Information
First Submitted Date  ICMJE March 5, 2014
First Posted Date  ICMJE March 17, 2014
Last Update Posted Date September 11, 2014
Study Start Date  ICMJE March 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02088398 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
  • 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.
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alternative 10 mg/mL Liquid Formulation of ACY 1215 (Ricolinostat) in Healthy Subjects
Official Title  ICMJE 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
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: ACY-1215
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: 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)
    Intervention: Drug: ACY-1215
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2014)
19
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2014)
20
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02088398
Other Study ID Numbers  ICMJE ACE-HV-100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acetylon Pharmaceuticals Incorporated
Study Sponsor  ICMJE Acetylon Pharmaceuticals Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicholas Siebers, M.D. Covance
PRS Account Acetylon Pharmaceuticals Incorporated
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP