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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01485965
• Date of registration: 29/11/2011
• Prospective Registration: No
• Primary sponsor: Siena Biotech S.p.A.
• Public title: A Open-label Food Effect Study With SEN0014196 in Subjects With Huntington Disease
• Scientific title: A Phase 1b, Open-label, Parallel-group Study in Subjects With Huntington Disease to Assess the Safety, Tolerability, and Fed/Fasted Pharmacokinetics of Repeated Oral Doses of SEN0014196
• Date of first enrolment: November 2011
• Target sample size: 26
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01485965
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Francis O Walker, MD
• Affiliation: Wake Forest School of Medicine

Key inclusion & exclusion 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



Age minimum: 25 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Huntington's Disease

Intervention(s)

Drug: SEN0014196

Primary Outcome(s)

To determine the effect of food on the repeated dose pharmacokinetics of SEN0014196 at 100 mg once daily in subjects with Huntington's disease [Time Frame: 14 Days]

Secondary Outcome(s)

Pharmacodynamics [Time Frame: 14 Days]

To determine the safety and tolerability of repeated doses of SEN0014196 at 100 mg once daily in subjects with Huntington's disease [Time Frame: 14 Days]

Secondary ID(s)

S015-007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors