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Phase 1b Study of SEN0014196 is Recruiting

A Phase 1b study to determine the safety, tolerability and fed/fast pharmacokinetics of repeated oral doses of SEN0014196 over a 14-day period is being conducted to evalute the effects of food on the Pharmacokinets of SEN0014196 in Subects with Huntington's disease.  Pharmacokinetics is the concentration of a drug in the body over a period of time, including factors such as how it is absorbed, how it is distributed in the body, what tissues it localizes in, how the drug is altered by human body chemistry, and how the drug is excreted.

Please read the following information about the trial, and review the list of sites at the end of this email. We hope you will contact your local site, or share this information with other members of your family who may be willing and eligible to participate.

SEN0014196 is an investigational drug not yet approved by the FDA. It  is a SirT1 Inhibitor, which is being studied as a  ipotential treatment for Huntington’s disease. In HD animal models it was found to reduce symptoms and increase lifespan by modifying the acetylation of the huntingtin protein to increase the rate of removal of the HD protein.

Locations: Seven Research Centers in the United States (see list and contact information below).

Participants: A total of 34 participants will be recruited for this study.

     •   Age: 25 to 65 years of age

     •   Early to mid-HD, with a genetic test CAG repeat equal or greater than 36, motor symptoms of HD and a Total Functional Capacity Subscale Score (TFC) equal or greater than 7

     •   Participants must be capable of providing informed consent

     •   Each participant must have a live-in partner or family member who can assist in case of emergency.r

     •   Participants must have a body weight greater than 110 pounds

     •   Participants should not have been in a study or received an investigational drug within 30 days of the baseline visit, no history of significant heart, kidney, blood or liver disease, hepatitis B, hepatitis C or a history of immunodeficiency. Potential participants must not be allergic to any ingredient in the study drug. More information on medical history and medication requirements can be obtained by a phone call to the investigator at your study location.

Trial Duration: 14 days and a total of 7 participant visits:  Screening; Baseline/Day1; Day 2; Day 7; Day 14; and Day 15. In addition, there will be a telephone contact the day before screening and on Day 13.

Each participant will take SEN014196 once daily in the morning for 14 consecutive days. Participants in the “fasted group” will take each dose after an overnight fast (no food after midnight). Additionally, on Visits 2 and 5 the “fasted” participants will not be allowed to eat for at least 4 hours after taking the drug. Participants in the “fed group” will take their dose of SEN0014196 within 30 minutes after starting breakfast. On Visit 2/Day one, all participants’ blood will be collected before taking their dose of SEN0014196, and at 0.5, 1, 2, 3, 4, 6 and 8 hours after taking it. On Visit 3 participants will return to the clinic in the morning for blood collection. Visit 4 will be a safety assessment exam and at Visit 5 all participants will have blood taken before taking their dose and four hours after taking their dose. Participants will return to their site on the morning of Visit 6 for post-dose blood collections and Visit 7 will occur 14 days after the last dose of the study drug and will include a final blood collection for analysis.

For more details please call one of the participating sites

For more information regarding this study please visit : http://www.clinicaltrials.gov/ct2/show/NCT01485965?term=Huntington%27s+disease%2C+Siena+Biotech&rank=2

Locations