Status:
COMPLETED
Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects
Lead Sponsor:
Kastle Therapeutics, LLC
Collaborating Sponsors:
Ionis Pharmaceuticals, Inc.
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The primary objective of this Phase I exploratory study is to determine the effects of mipomersen on the hepatic production of apolipoprotein-B (apo B) in very low density lipoprotein (VLDL) compared ...
Eligibility Criteria
Inclusion
- Non-pregnant, non-lactating, surgically sterile, postmenopausal, abstinent, or the subject or partner is compliant with an acceptable contraceptive regimen for 4 weeks prior to Screening and willing to remain compliant with the contraceptive regimen throughout treatment and for 25 weeks after the last investigational product dose
- Body weight \>50 kg, body mass index (BMI) ≤38 kg/m2, and stable weight (i.e., within 5% of mean body weight) for \> 8 weeks prior to Screening
- Fasting TG levels of ≤170 mg/dL, fasting serum blood glucose of ≤115 mg/dL, and an HbA1c ≤6.5%
Exclusion
- Presence of any clinically significant abnormal laboratory profiles, physical exams, vital signs, or ECGs
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, infectious, or psychiatric disease
- Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for \>1 year) at Screening
- History of relevant food and/or drug allergies (i.e., allergy to heparin or any significant food allergy that could preclude a stable diet)
- The subject is receiving prescription lipid-lowering therapies such as statins, bile acid sequestrants, niacin/nicotinic acid, and/or fibrates or over-the-counter (OTC) fish oils, flaxseed, red rice or nutrient supplements that might affect lipid levels
- The subject is unwilling to limit alcohol consumption for the entire duration of the study
- The subject smokes \>5 cigarettes per day
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01414881
Start Date
September 1 2011
End Date
November 1 2012
Last Update
August 3 2016
Active Locations (1)
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1
Columbia-Presbyterian Medical Center, MS Care Center
New York, New York, United States