Status:
COMPLETED
A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone
Lead Sponsor:
Halozyme Therapeutics
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00979875
Start Date
September 1 2009
End Date
May 1 2010
Last Update
July 14 2014
Active Locations (1)
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1
Profil Institute for Clinical Research, Inc.
Chula Vista, California, United States, 91911