Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ISIS 463588
This trial is active, not recruiting.
|Treatments||isis 463588, placebo|
|Sponsor||Translational Research Institute for Metabolism and Diabetes, Florida|
|Start date||June 2015|
|End date||October 2016|
|Trial size||15 participants|
|Trial identifier||NCT02463240, TRIMD FH 647112|
The purpose of this research study is to find out more about the safety and tolerability of an investigational drug called ISIS 463588.
|Endpoint classification||pharmacokinetics/dynamics study|
|Intervention model||single group assignment|
|Masking||double blind (subject, investigator)|
|Primary purpose||basic science|
Measure change in energy expenditure
time frame: Baseline, Days 92, 93, 106, 107
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: - Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements - Males or females between 18 to 65 years old at the time of informed consent - Females must be post-menopausal (defined as 12 months of spontaneous amenorrhea in females > 55 years of age or, in females ≤ 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and follicle stimulating hormone levels in the postmenopausal range for the laboratory involved) - Male subjects must be surgically sterile, abstinent or if engaged in sexual relations with women of childbearing potential, patient is utilizing an acceptable contraceptive method during and for 5 months after the last dose of ISIS 463588 or placebo (Study Drug) - Body Mass Index (BMI) between 30.0 and 40.0 kg/m2, inclusive - Patients who are willing to comply with all scheduled visits, treatments plans, laboratory tests and other study procedures - Agree to abstain from alcoholic beverages for at least 48 hrs prior to clinic visits - Agree to maintain current diet and exercise regimen from Screening until End-of-Study Exclusion Criteria: - Clinically significant abnormalities in medical history (e.g., previous acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening) or physical examination - Persistently positive test (including trace) for blood on urinalysis at Screening. In the event of a positive test eligibility may be confirmed with urine microscopy showing < 5 red blood cells (RBC) per high power field (persistently positive defined as 2 out of 3) - Urine protein/creatinine (P/C) ratio ≥ 0.2 mg/mg at Screening. In the event of P/C ratio above this threshold eligibility may be confirmed by a quantitative total urine protein measurement of < 300 mg/24 hr - Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, alkaline phosphatase, serum creatinine, blood urea nitrogen (BUN), activated partial thromboplastin time (aPTT) or Prothrombin Time (PT) > Upper Limit Normal - Diagnosis of Night Eating Syndrome and/or binge eating - Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated - Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results at Screening (TSH/T3/T4). Patients receiving dose-stable thyroid hormone replacement therapy for at least 3 months prior to Screening will be allowed to participate as long as the thyroid tests show that the patient is euthyroid - Use of weight loss agents (including herbal or over-the counter weight loss preparations) and other medications that cause weight loss in the 3 months prior to Screening - Chronic or acute prescription medications unless permitted by the Sponsor Medical Monitor during the study - Undergoing or have undergone treatment with another investigational drug, biological agent, or device within one month of Screening, (or 5 half-lives of investigational agent, whichever is longer) prior to Screening - Treatment with an antisense oligonucleotide within 5 months of Screening. Patients that have previously received only a single dose of an antisense oligonucleotide as part of a clinical study may be included as long as 30 days have elapsed prior to Screening - Blood donation of 50 to 499 mL within 30 days of Screening or of > 499 mL within 60 days of Screening - Active infection requiring systemic antiviral or antimicrobial therapy within 14 days before Study Drug administration - Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator - Regular use of alcohol within 6 months prior to Screening (> 7 drinks/week for females, > 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor), or use of soft drugs (such as marijuana) within 3 months prior to Screening, or hard drugs (such as cocaine and phencyclidine (PCP) ) within 1 year prior to Screening, or positive urine drug screen at Screening - Weight change > 5% in the 3 months prior to Screening - Weight change +/- 2 kgs (4.4 lbs) between Screening Day -37 and the average of Day -4 and Day -2 - Subject has taken in the last 6 weeks prior to Screening over-the-counter fish oils or prescription lipid-regulating drugs (e.g., bile-acid sequestering resins, fibrates and derivatives) other than statins - Patients receiving treatment with statins must have been on a stable dose and regimen for ≥ 3 months prior to Screening and should be within the dose levels listed below. - Simvastatin at ≤ 40 mg/day - Atorvastatin and fluvastatin up to 40 mg/day - Rosuvastatin up to 20 mg/day or pravastatin up to 40 mg/day - Pitavastatin up to 4 mg/day - Prior history of surgical weight loss procedure (e.g., gastric bypass, lap band) - Metal implants (pace-maker, non-removable body piercings, aneurysm clips) - Unable to participate in magnetic resonance imaging (MRI) or magnetic resonance spectroscopy (MRS) assessments due to physical limitations of equipment tolerances (e.g., MRI bore size) based on Investigator's judgment at Screening - Unable to tolerate MRI/MRS imaging or claustrophobia
|Official title||A Double Blind, Randomized, Placebo-controlled, Single Center, Phase 2a Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 463588 Administered Subcutaneously Once Weekly for 13 Weeks in Obese Patients|
|Principal investigator||Steven Smith, MD|
|Description||Study Objectives: 1. Evaluate pharmacodynamic indices of energy expenditure following a once-weekly, 13 Week dosing paradigm of ISIS 463588 in obese patients. 2. Evaluate the safety and tolerability of ISIS 463588 in obese patients following a once-weekly dosing paradigm for 13 weeks.|
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