A Open-label Food Effect Study With SEN0014196 in Subjects With Huntington Disease

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Siena Biotech S.p.A.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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