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

Siena Biotech

Status and phase: Completed; Phase 1

Conditions: Huntington's Disease

Treatments: Drug: SEN0014196

Study type: Interventional

Funder types: Industry

Identifiers

NCT01485965

S015-007

Details and patient eligibility

About

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).

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Fasted condition

Experimental group

Description:

Subjects in the Fasted group will take study drug after an overnight fast (since at least midnight). Additionally, on PK assessment days, no food will be allowed for at least 4 hours after study drug administration.

Treatment:

Drug: SEN0014196

Fed condition

Experimental group

Description:

Subjects in the Fed group will take study drug within 30 minutes after starting breakfast; these subjects will otherwise maintain their normal eating schedule.

Treatment:

Drug: SEN0014196