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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT02088398

Run by

Acetylon Pharmaceuticals Incorporated

People needed

19

Starts

2014-03-01

Expected to finish

2014-04-01

Last updated by the study team

2014-09-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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

Where it is running

• Covance Clinical Research Unit Incorporated — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.