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

NCT02088398 | Completed Phase 1 DMC

• 1 other identifier: ACE-HV-100
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

relative bioavailability; food-effect

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve From Zero to Last Time - AUC0-last

  0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose

Secondary Outcomes (4)

• Safety and tolerability parameters

  Day 1 (first dose of ACY-1215) to Day 16

• Area Under the Curve From Time Zero to Extrapolated Infinite Time

  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)

  0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose

• Plasma Decay Half-Life

  0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose

Study Arms (3)

160 mg ACY-1215 CLF (20 mg/mL) fed

EXPERIMENTAL

• Treatment A: a single dose of 160 mg ACY-1215 CLF (20 mg/mL) in the fed state

Drug: ACY-1215

120 mg ACY-1215 ALF (10 mg/mL) fed

EXPERIMENTAL

• Treatment B: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fed state

Drug: ACY-1215

120 mg ACY-1215 ALF (10 mg/mL) fasted

EXPERIMENTAL

• Treatment C: a single dose of 120 mg ACY-1215 ALF (10 mg/mL)

Drug: ACY-1215

Interventions

ACY-1215 DRUG

120 mg ACY-1215 ALF (10 mg/mL) fasted; 120 mg ACY-1215 ALF (10 mg/mL) fed; 160 mg ACY-1215 CLF (20 mg/mL) fed

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acetylon Pharmaceuticals Incorporated: lead

Study Sites (1)

Covance Clinical Research Unit Incorporated

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

ricolinostat

Study Officials

• Nicholas Siebers, M.D.

  Covance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 17, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 11, 2014

Record last verified: 2014-09

Locations

US (1)