Diabetes Mellitus disorder with hyperglycemia
Conditions
Interventions
ISIS 388626 or placebo (0.9% sterile saline)
Sponsors
ISIS Pharmaceuticals
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers aged between 18 to 65 years 2. Male or female gender although females must be post-menopausal or surgically sterile (hysterectomy, oophrectomy or tubal ligation). 3. Give written informed consent to participate in the study and availability for all study requirements 4. Fasting plasma glucose
Exclusion criteria
Exclusion criteria: 1. Pregnant women, nursing mothers or women of childbearing potential 2. Presence of any of the following conditions: a. Clinically significant abnormalities in medical history or physical examination b. Clinically significant abnormalities in laboratory examination. (ALT > ULN, AST > ULN, bilirubin > ULN, creatinine > ULN, urine protein positive by dipstick, platelets 1 year) h. Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in this study or interfere with compliance 3. History of alcohol or drug abuse 4. Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to Screening. 5. Blood donation within three months of Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoints The safety and tolerability of ISIS 388626 will be assessed by determining the incidence, severity and dose-relationship of adverse effects and changes in laboratory evaluations within each dose cohort. Safety results in subjects dosed with ISIS 388626 will be compared with those from subjects dosed with placebo. Pharmacokinetic Endpoints The pharmacokinetics of ISIS 388626 will be assessed following single and multiple dose administration. Plasma concentration of ISIS 388626 and percent of administered dose in urine at the selected 0-24 and 24-48 hour intervals will be determined. Pharmacodynamic Endpoints Pharmacodynamic assessments will be made in all the multiple dosing cohorts by measuring the change in urinary glucose excretion from Baseline following six or thirteen-weeks of ISIS 388626 dosing and at other time-points. Additional pharmacodynamic assessments will compare plasma glucose concentration in response to an oral glucose tolerance test and inhibition of urinary glucose reabsorption conducted prior to and following thirteen-weeks of ISIS 388626 dosing, and at other time-points. | — |
Countries
Netherlands
Outcome results
None listed