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

NCT01485965 | Completed Phase 1

• 1 other identifier: S015-007
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 7

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).

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

Outcome Measures

Primary Outcomes (1)

• To determine the effect of food on the repeated dose pharmacokinetics of SEN0014196 at 100 mg once daily in subjects with Huntington's disease

  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).

  14 Days

Secondary Outcomes (2)

• Pharmacodynamics

  14 Days

• To determine the safety and tolerability of repeated doses of SEN0014196 at 100 mg once daily in subjects with Huntington's disease

  14 Days

Study Arms (2)

Fasted condition

EXPERIMENTAL

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.

Drug: SEN0014196

Fed condition

EXPERIMENTAL

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

Drug: SEN0014196

Interventions

SEN0014196 DRUG

100 mg, immediate release tablets, once daily administration

Fasted condition; Fed condition

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siena Biotech S.p.A.: lead

Study Sites (7)

University of California San Diego

La Jolla, California, 92037-0706, United States

Location

University of California Davis Medical Center

Sacramento, California, 95655, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Rochester

Rocherster, New York, 14627, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157-1078, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8527, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

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

Interventions

6-chloro-2,3,4,9-tetrahydro-1H-carbazole-1-carboxamide

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurocognitive Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francis O Walker, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 6, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 20, 2013

Record last verified: 2013-03

Locations

US (7)