Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715

NCT00365781 | Completed Phase 1

• 1 other identifier: ISIS 113715-CS13
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS 113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a 5-minute period. On Study Days 2 and 8, each subject's injection sites will be assessed for dermatologic effects. The Isis Project Physician(s) will observe the injection sites on Study Day 2 and may also observe on Study Day 8. Routine clinical chemistry, hematology, and urinalysis tests will be performed on Study Day 1 and Day 8. Subjects will be contacted by telephone on Study Day 30 to monitor for the occurrence of new serious adverse events (SAEs). Thereafter, the subjects will be discharged from the study.

Conditions

Type 2 Diabetes Mellitus

Keywords

Injection Site Reaction; Subcutaneous administration; Dermatological effects; Antisense

Outcome Measures

Primary Outcomes (2)

• Compare the dermatologic responses to 200 mg/1.0 mL and 200 mg/2.0 mL ISIS 113715 administered subcutaneously into separate abdominal sites, with both injections given on the same day.

• Evaluate and examine the effect of treatment on laboratory results, vital signs, and adverse events.

Interventions

ISIS 113715 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female: Females are post menopausal or surgically sterile; Males are surgically sterile, abstinent, or utilizing an acceptable barrier contraceptive method. Must also agree to continue abstinence and/or to use an acceptable barrier contraceptive method for at least four weeks after their injections of ISIS 113715
• Aged 18 to 65 years
• Weight \> 50 kg
• Body mass index \> 29 kg/m²

You may not qualify if:

• Pregnant, breastfeeding, or intends to become pregnant
• Positive hepatitis B virus, hepatitis C virus, or HIV test
• History of clinical significant abnormalities in complement or coagulation parameters or taking medication that may affect coagulation (e.g., heparin, warfarin), except aspirin or non-steroidal anti-inflammatory agents (NSAID)
• Current or history of significant skin disorders
• History of alcohol or drug abuse
• History of liver or renal disease
• Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for \> one year)
• Liver function tests greater than the Upper Limit of Normal (ULN)
• Clinically significant and currently active diseases or active infection requiring antiviral or antimicrobial therapy

Sponsors & Collaborators

• Ionis Pharmaceuticals, Inc.: lead

Study Sites (1)

Therapeutics Clinical Research

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Injection Site Reaction

Interventions

ISIS-113715

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Extravasation of Diagnostic and Therapeutic Materials; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Mark K Wedel, MD, JD, FACP

  Ionis Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 15, 2006
• First Posted: August 17, 2006
• Study Start: August 1, 2006
• Study Completion: September 1, 2006
• Last Updated: October 17, 2007

Record last verified: 2007-10

Locations

US (1)