A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20 (rHuPH20), insulin lispro alone, insulin glulisine + rHuPH20, insulin glulisine alone, insulin aspart + rHuPH20, and insulin aspart alone.

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

Details

• Lead Sponsor: Halozyme Therapeutics
• Treatments: Insulin; Insulin Aspart; Insulin glulisine; Insulin Lispro; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Healthy participants between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities).

• Body mass index (BMI) between 18-27 kilograms per meter squared (kg/m^2), inclusive.

• Total body weight >65 kilograms (kg) (143 pounds [lb]) for men and >46 kg (101 lb) for women.

• Decision making capacity and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including adequate venous access.

• Vital signs (blood pressure [BP], pulse rate, body temperature) within normal range or, if out of range, assessed by the Principal Investigator as not clinically significant.

• Fasting blood glucose level <100 milligrams per deciliter (mg/dL) at screening.

• A negative serum pregnancy test (if female of childbearing potential).

• Female participants of childbearing potential must agree to practice effective birth control or abstinence currently and agree to continue to do so for the duration of their time on study.

• Signed, written institutional review board (IRB)-approved informed consent.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, oncologic, or neurologic (to include history of seizures) disease; hypoglycemic episodes; intercurrent illness (such as influenza); or allergic disease (including severe drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Clinical significance to be determined by the Principal Investigator.

• As judged by the investigator, clinically significant findings in routine laboratory data. (Anemia with hematocrit less than 33% at screening is specifically exclusionary.)

• Known history of diabetes mellitus (type 1 or type 2) or gestational diabetes.

• Known allergy to hyaluronidase or any other ingredient in the study drug.

• Positive human immunodeficiency virus (HIV) 1, hepatitis B, or hepatitis C antibody test.

• History or evidence of alcohol or drug abuse.

• History or evidence of use of any tobacco- or nicotine-containing product within 6 months prior to screening and a screening qualitative urine nicotine test.

• Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action or glucose utilization.

• Blood donation or high volume phlebotomy, for example, >100 milliliters (mL), within 56 days before dosing.

• Participation in a study of any investigational drug or device 30 days before enrollment in this study.

• The participant is unfit for the study in the opinion of the investigator.

• Women who are pregnant or breast-feeding.