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Safety Study of ISIS 325568 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00519727
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : August 19, 2008
Sponsor:
Information provided by:
Ionis Pharmaceuticals, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: ISIS 325568 Phase 1

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
50 mg ISIS 325568 vs Placebo, s.c. injection
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: B
100 mg ISIS 325568 vs Placebo , s.c. injection
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: C
200 mg ISIS 325568 vs Placebo , s.c. injection
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: D
400 mg ISIS 325568 vs Placebo, s.c. injection
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: AA
50 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo
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: BB
100 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo
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: CC
200 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo
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: DD
400 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo
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




Primary Outcome Measures :
  1. safety and tolerability [ Time Frame: 30 days for single dose, 16 weeks for multi-dose ]

Secondary Outcome Measures :
  1. Pharmacokinetic profile all doses and Pharmacodynamics for multi-dose groups. [ Time Frame: 4 days for single dose, 16 weeks for multi-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519727


Locations
Netherlands
Centre for Human Drug Research
Leiden, Netherlands
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
Investigators
Principal Investigator: J. Burggraaf, MD PhD Centre for Human Drug Research

Responsible Party: Sanjay Bhanot, MD, VP of Research and Development, ISIS Pharmaceuticals Medical Monitor
ClinicalTrials.gov Identifier: NCT00519727     History of Changes
Other Study ID Numbers: ISIS 325568-CS1
EudraCT No: 2007-000235-25
First Posted: August 23, 2007    Key Record Dates
Last Update Posted: August 19, 2008
Last Verified: August 2008

Keywords provided by Ionis Pharmaceuticals, Inc.:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases