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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01485965
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : March 20, 2013
Information provided by (Responsible Party):
Siena Biotech S.p.A.

November 29, 2011
December 6, 2011
March 20, 2013
November 2011
November 2012   (Final data collection date for primary outcome 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 [ Time Frame: 14 Days ]
The effect of food on the PK of SEN0014196 will be evaluated for the following parameters: maximum observed plasma concentration (Cmax), time of maximum observed plasma concentration(tmax), AUC from time zero to the length of the dosing interval (tau) (AUC0-τ), AUC from time zero to the last quantifiable concentration (AUC0-last), AUC from time zero to infinity (AUC0-∞), terminal elimination half-life (t1/2), and terminal elimination rate constant (λz).
Same as current
Complete list of historical versions of study NCT01485965 on Archive Site
  • Pharmacodynamics [ Time Frame: 14 Days ]
    The following PD biomarkers will be assessed: soluble huntingtin levels and huntingtin acetylation status (by enzyme-linked immunosorbent assay [ELISA] and liquid chromatography-tandem mass spectrometry [LC-MS/MS]).
  • 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 ]
    Safety assessments include: AEs, ECGs, vital signs, body weight and height, clinical laboratory evaluations (serum biochemistry and hematology), urinalysis, physical and neurological examinations, C-SSRS, and UHDRS.
Same as current
Not Provided
Not Provided
A Open-label Food Effect Study With SEN0014196 in Subjects With Huntington Disease
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
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).
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.
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Huntington's Disease
Drug: SEN0014196
100 mg, immediate release tablets, once daily administration
  • Experimental: Fasted condition
    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.
    Intervention: Drug: SEN0014196
  • Experimental: Fed condition
    Subjects in the Fed group will take study drug within 30 minutes after starting breakfast; these subjects will otherwise maintain their normal eating schedule.
    Intervention: Drug: SEN0014196
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
25 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Siena Biotech S.p.A.
Siena Biotech S.p.A.
Not Provided
Principal Investigator: Francis O Walker, MD Wake Forest University Health Sciences
Siena Biotech S.p.A.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP