Safety, Tolerability and Activity Study of Multiple Doses of ISIS-SGLT2Rx in Healthy Volunteers

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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 multiple times.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• 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
• HbA1c
• BMI < 30 kg/m²

• Agree to maintain steady hydration throughout study participation and agree not to fluid restrict

Exclusion Criteria:

• 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