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Safety Study of ISIS 325568 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00519727
First received: August 21, 2007
Last updated: August 15, 2008
Last verified: August 2008

August 21, 2007
August 15, 2008
August 2007
April 2008   (final data collection date for primary outcome measure)
safety and tolerability [ Time Frame: 30 days for single dose, 16 weeks for multi-dose ] [ Designated as safety issue: Yes ]
safety and tolerability [ Time Frame: 30 days for single dose, 16 weeks for multi-dose ]
Complete list of historical versions of study NCT00519727 on ClinicalTrials.gov Archive Site
Pharmacokinetic profile all doses and Pharmacodynamics for multi-dose groups. [ Time Frame: 4 days for single dose, 16 weeks for multi-dose ] [ Designated as safety issue: No ]
Pharmacokinetic profile all doses and Pharmacodynamics for multi-dose groups. [ Time Frame: 4 days for single dose, 16 weeks for multi-dose ]
Not Provided
Not Provided
 
Safety Study of ISIS 325568 in Healthy Volunteers
A Phase I, Double-Blind, Placebo-Controlled, Dose- Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 325568 Administered to Healthy Volunteers

The primary purpose of this trial is to assess the safety of ISIS 325568 when given at increasing single doses and to assess the safety of the same doses when given multiple times.

To evaluate the safety of a single subcutaneous injection of ISIS 325568 administered at four increasing dose levels (50, 100, 200, 400 mg/week) and to evaluate the safety and tolerability of multiple doses of ISIS 325568 (three intravenous doses during Study Week 1, followed by once weekly subcutaneous administration for 5 weeks) at each of the four dose levels

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: ISIS 325568

4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg

Placebo: 0.9% Sodium Chloride

  • Experimental: A
    50 mg ISIS 325568 vs Placebo, s.c. injection
    Intervention: Drug: ISIS 325568
  • Experimental: B
    100 mg ISIS 325568 vs Placebo , s.c. injection
    Intervention: Drug: ISIS 325568
  • Experimental: C
    200 mg ISIS 325568 vs Placebo , s.c. injection
    Intervention: Drug: ISIS 325568
  • Experimental: D
    400 mg ISIS 325568 vs Placebo, s.c. injection
    Intervention: Drug: ISIS 325568
  • Experimental: AA
    50 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo
    Intervention: Drug: ISIS 325568
  • Experimental: BB
    100 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo
    Intervention: Drug: ISIS 325568
  • Experimental: CC
    200 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo
    Intervention: Drug: ISIS 325568
  • Experimental: DD
    400 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo
    Intervention: Drug: ISIS 325568
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18 to 65 years
  2. Males or females. Females must be non-pregnant and non-lactating, and either surgically sterile (hysterectomy, oophorectomy, or tubal ligation) or post-menopausal. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, subject or partner must be using an acceptable contraceptive method during the trial and for 9 weeks after the last dose of study drug.
  3. Give written informed consent to participate in study and availability for all study requirements
  4. Fasting plasma glucose ≤ the upper limit of the laboratory's reference range (ULN)
  5. HbA1C ≤ ULN
  6. BMI < 30 kg/m2

Exclusion Criteria:

  1. Clinically significant abnormalities in medical history or physical examination
  2. Abnormalities on laboratory examination (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)
  3. History of clinically significant abnormalities in coagulation parameters
  4. Positive test result for HIV, hepatitis B virus, and/or hepatitis C virus
  5. Active infection requiring antiviral or antimicrobial therapy
  6. Subjects on chronic or acute prescription medication may be permitted after discussion with the Isis Medical Monitor.
  7. Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > 1 year)
  8. Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in this study or interfere with compliance
  9. History of alcohol or drug abuse
  10. Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to Screening.
  11. Blood donation within three months of screening
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00519727
ISIS 325568-CS1, EudraCT No: 2007-000235-25
No
Sanjay Bhanot, MD, VP of Research and Development, ISIS Pharmaceuticals Medical Monitor
Isis Pharmaceuticals
Not Provided
Principal Investigator: J. Burggraaf, MD PhD Centre for Human Drug Research
Isis Pharmaceuticals
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP