Clinical trial NCT01485965: A Open-label Food Effect Study With SEN0014196 in Subjects With Huntington Disease
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Huntington's Disease
Keywords: Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Mental Disorders
Lead sponsor: Siena Biotech S.p.A.
Sponsor class: INDUSTRY
First posted: 2011-12-06
Enrollment: 26
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 biomarkers for use in subsequent Phase 2/3 studies.

Eligibility 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

Primary outcomes:
measure: To determine the effect of food on the repeated dose pharmacokinetics of SEN0014196 at 100 mg once daily in subjects with Huntington's disease
timeFrame: 14 Days
Secondary outcomes:
measure: Pharmacodynamics
timeFrame: 14 Days
measure: To determine the safety and tolerability of repeated doses of SEN0014196 at 100 mg once daily in subjects with Huntington's disease
timeFrame: 14 Days
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Rocherster
country: United States
facility: University of Rochester
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Wake Forest University Health Sciences
name: Francis O Walker, MD
role: PRINCIPAL_INVESTIGATOR
References: