Status:
COMPLETED
Pharmacokinetic (PK), Pharmacodynamic (PD), and Safety Study of Subcutaneously Administered Humalog® With and Without Recombinant Human Hyaluronidase (rHuPH20)and Humulin-R® With and Without rHuPH20
Lead Sponsor:
Halozyme Therapeutics
Conditions:
Diabetes Mellitus
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of Humalog (insulin lispro) or Humulin-R (recombinant human insulin) when administered as a single subcutaneo...
Eligibility Criteria
Inclusion
- Healthy male participants aged 18 to 55 years.
- Body mass index (BMI) 18 to 28 kilograms per meter squared (kg/m\^2) and total body weight \>70 kilograms (kg) (154 pounds \[lb\]).
- Willingness and ability to comply with the protocol.
- Vital signs within the normal range.
- Within 7 days before the first injection, metabolic panel results and complete blood count (CBC) within the laboratory normal reference range.
- Fasting plasma glucose within the normal range of 90 to 110 milligrams per deciliter (mg/dL) on the morning of the glucose clamp.
- Agreement not to father a child or donate sperm and to use effective contraception during the study and for at least 30 days after study completion.
- Willingness and ability to sign an informed consent form.
Exclusion
- Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic (to include history of seizures) or allergic disease, or history of hypoglycemic episodes.
- Known history of diabetes mellitus.
- Prior exposure to any insulin or insulin analogs.
- Known allergy to hyaluronidase or any other ingredient in HYLENEX.
- Known allergy to bee or vespid venom.
- Positive urine drug screen results.
- Positive human immunodeficiency virus (HIV) 1, HIV 2, hepatitis B, or hepatitis C antibody test result.
- Any history or evidence of alcohol or drug abuse.
- History or evidence of use of any tobacco- or nicotine-containing product within 6 months of screening, or screening urine nicotine concentration \>50 nanograms per milliliter (ng/mL).
- Use of prescription or nonprescription drugs within 7 days or 5 half-lives, whichever was shorter, except acetaminophen at doses of less than or equal to 1 gram per day (g/day).
- Donation of blood in excess of 500 milliliters (mL) within 56 days before dosing.
- Failure to limit alcohol consumption and refrain from exercise within 48 hours before each injection.
- Known clinically significant intercurrent illness or other major systemic disease that would unduly risk the participant's safety or interfere with the interpretation of results.
- Participation in a study of any investigational drug or device 30 days before enrollment in this study.
- Unfitness for the study, in the investigator's opinion.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00705536
Start Date
December 1 2007
End Date
February 1 2008
Last Update
February 26 2019
Active Locations (1)
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1
Diabetes and Glandular Disease Research, Inc.
San Antonio, Texas, United States, 78229