Status:
COMPLETED
A Open-label Food Effect Study With SEN0014196 in Subjects With Huntington Disease
Lead Sponsor:
Siena Biotech S.p.A.
Conditions:
Huntington's Disease
Eligibility:
All Genders
25-65 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to assess the effect of food upon the pharmacokinetics (PK) of SEN0014196 in subjects with Huntington disease (HD).
Detailed Description
In addition to the pharmacokinetic endpoints, the study will assess the safety and tolerability of 100 mg once daily (qd) doses of SEN0014196 over 14 days in subjects with HD and explore potential bio...
Eligibility Criteria
Inclusion
- Subjects with early to mid HD, i.e., genetically confirmed HD (cytosine, adenine, guanine \[CAG\] codon repeat length ≥ 36), motor signs of HD, and a Total Functional Capacity Subscale Score (TFC) ≥ 7
- Body mass index between 18 and 31 kg/m2 inclusive
- All subjects must have a body weight greater than 50 kg
- Female subjects must be surgically sterile, postmenopausal, or willing to practice a highly effective method of contraception. All female participants must be nonlactating and nonpregnant. Male subjects must agree to use a reliable method of birth control during the study and for 3 months after the last dose of study drug.
- Capable of providing informed consent
- MMSE ≥24
- Subjects must have a live-in competent observer
Exclusion
- Participation in a study or received an investigational drug within 30 days of the Baseline Visit
- Any prior or concomitant use of compounds suspected of interfering with protein acetylation
- Any concomitant use of medications that are known inhibitors of CYP450 enzymes or substrates of CYP1A2 at the time of enrollment
- Suicide risk, as determined by meeting either of the following criteria: a) a suicide attempt within the past year or suicidal ideation within 60 days of the Screening Visit; b) Significant risk of suicide, as judged by the Investigator
- Subjects with MMSE \< 24
- Subjects with presence of clinically significant psychosis and/or confusional states, in the opinion of the Investigator
- Subjects with clinically significant laboratory or ECG abnormalities at Screening or Baseline
- Subjects with clinically relevant hematologic, hepatic, cardiac, or renal disease
- Subjects with a current or past (within the last 12 months) history of epilepsy or seizures
- A medical history of infection with human immunodeficiency virus, hepatitis C, and/or hepatitis B
- Subjects with a history of substance abuse within the past 12 months
- Female subjects who are pregnant or breastfeeding
- Known allergy to any ingredient in the study drug
- A history of malignancy of any type within 2 years prior to Screening. A history of surgically-excised nonmelanoma skin cancers is permitted.
- Any relevant condition, behavior, laboratory value, or concomitant medication which, in the opinion of the Investigator, makes the subject unsuitable for entry into the study
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01485965
Start Date
November 1 2011
End Date
December 1 2012
Last Update
March 20 2013
Active Locations (7)
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1
University of California San Diego
La Jolla, California, United States, 92037-0706
2
University of California Davis Medical Center
Sacramento, California, United States, 95655
3
Washington University
St Louis, Missouri, United States, 63110
4
University of Rochester
Rocherster, New York, United States, 14627