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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Acetylon Pharmaceuticals Incorporated
• Treatments: Ricolinostat

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