Treatment Development of Triheptanoin (G1D)

Exclusion Criteria

• •Subjects with a history of life-threatening seizure episodes, including but not limited to status epilepticus and cardiac arrest.
• •Subjects with evidence of independent, unrelated metabolic and/or genetic disease.
• •Subjects with a body mass index (BMI) greater than or equal to 30.
• •Subjects with a chronic gastrointestinal disorder, such as irritable bowel syndrome, Crohn's disease, or colitis, which could increase the subject's risk of developing diarrhea or stomach pain.
• •Subjects currently on dietary therapy (i.e., ketogenic diet, medium chain triglyceride-supplemented diets, Atkins diet, low glycemic index diet, and related diets).
• •Women who are pregnant or breast-feeding may not participate.
• •Women who plan to become pregnant during the course of the study, or who are unwilling to use birth control to prevent pregnancy (including abstinence) may not participate.
• •Females age 10 and over will be asked to provide a urine sample for a pregnancy test via dipstick.
• •Subjects will be asked to agree to abstinence or another form of birth control for the duration of the study.
• •Allergy/sensitivity to C7.
• •Previous treatment with C7 one month prior to enrollment.
• •Treatment with medium chain triglycerides in the last 30 days.
• •Subjects exhibiting signs of dementia, or diagnosed with any degenerative brain disorder (such as Alzheimer's disease) that would confound assessment of cognitive changes, in the opinion of the investigator.
• •Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
• •Inability or unwillingness of 1 parent or legal guardian/representative to give written informed consent.