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

NCT ID: NCT01485965

Last Updated: 2013-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-12-31

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.

Conditions

Huntington's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SEN0014196

Intervention Type: DRUG

100 mg, immediate release tablets, once daily administration

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.

Group Type: EXPERIMENTAL

SEN0014196

Intervention Type: DRUG

100 mg, immediate release tablets, once daily administration

Interventions

SEN0014196

100 mg, immediate release tablets, once daily administration

Intervention Type: DRUG

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siena Biotech S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis O Walker, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

University of California San Diego

La Jolla, California, United States

University of California Davis Medical Center

Sacramento, California, United States

Washington University

St Louis, Missouri, United States

University of Rochester

Rocherster, New York, United States

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

S015-007

Identifier Type: -

Identifier Source: org_study_id