Status:
COMPLETED
Safety, Tolerability and Activity Study of Multiple Doses of ISIS-SGLT2Rx in Healthy Volunteers
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The primary purpose of this trial is to assess the safety and tolerability of ISIS-SGLT2Rx when given at increasing single doses and to assess the safety and tolerability of the same doses when given ...
Detailed Description
To evaluate the safety and tolerability of a single subcutaneous injection of ISIS-SGLT2Rx administered at four increasing dose levels (50, 100, 200, 400 mg) and to evaluate the safety and tolerabilit...
Eligibility Criteria
Inclusion
- Age 18 to 65 years
- Male or female gender although females must be post-menopausal or surgically sterile (hysterectomy, oophorectomy or tubal ligation)
- Give written informed consent to participate in the study and availability for all study requirements
- Fasting plasma glucose \</= the upper limit of the laboratory's reference range (ULN)
- HbA1c \</= ULN
- BMI \< 30 kg/m²
- Agree to maintain steady hydration throughout study participation and agree not to fluid restrict
Exclusion
- Pregnant women, nursing mothers or women of childbearing potential
- Clinically significant abnormalities in medical history or physical examination
- Clinically significant abnormalities in laboratory examination (including ALT \> ULN, AST \> ULN, bilirubin \> ULN, creatinine \> ULN, urine protein positive by urine dipstick, platelets \< lower limit of normal and any other clinically significant laboratory findings)
- Estimated GFR \< 60 mL/min per 1.73m²
- History of clinically significant abnormalities in coagulation parameters
- Positive test result for HIV, hepatitis B virus, and/or hepatitis C virus
- Active infection requiring antiviral or antimicrobial therapy
- Subjects on chronic or acute prescription medication may be permitted after discussion with the Isis Medical Monitor
- Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for \> 1 year)
- Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in this study or interfere with compliance
- Past and present history of alcohol or drug abuse (defined as \> 3 units daily)
- Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to Screening
- Blood donation within three months of Screening
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00836225
Start Date
January 1 2009
End Date
January 1 2012
Last Update
February 3 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Human Drug Research
Leiden, Netherlands