Clinical trial NCT01634165: A Study of LY2963016 in Healthy Participants
Official title: Pharmacokinetics and Pharmacodynamics of LY2963016 Compared to Lantus® in Healthy Subjects Following Two Single Subcutaneous Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-07-06
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study involves 2 single injections of LY2963016 and 2 single injections of Lantus. There will be at least 6 days between each injection.

The study will compare LY2963016 to Lantus at two different doses.

This study is approximately 10 weeks long, not including screening. Screening is required within 4 weeks of the start of the study.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females
* Women must be either surgically sterile, post-menopausal, or agree to use a reliable method of birth control during the study
* Have a body mass index between 18.5 and 29.9 kilograms per meter squared (kg/m²)
* Are nonsmokers and have not smoked for at least 6 months prior to entering the study
* Have normal blood pressures and pulse rates at screening, as determined by the investigator
* Have an electrocardiogram (ECG) at screening considered as within normal limits by the investigator
* Have clinical laboratory test results within normal reference range for the population
* Have fasting plasma glucose \<110 milligrams per deciliter (mg/dL) (\<6.0 micromoles per liter \[mmol/L\]) at screening
* Have venous access sufficient to allow for blood sampling, intravenous drug administration, and clamp procedures as per the protocol
* Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site

Exclusion Criteria:

* Are persons who have previously completed or withdrawn from this study
* Are currently enrolled in or have discontinued within the last 30 days from a clinical trial involving an investigational drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Show evidence of significant active neuropsychiatric disease
* Show evidence of current use of known drugs of abuse or have a history of use within the past year
* Have a history of first-degree relatives known to have diabetes mellitus
* Show evidence of an acute infection with fever or infectious disease at the time of study entry
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening
* Have positive hepatitis B surface antigens at screening
* Intend to use over-the-counter medication within 7 days or prescription medication within 14 days prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement, or birth control methods)
* Have donated blood or had a blood loss of 450 milliliters (mL) 3 months prior to study enrollment
* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) or are unwilling to stop alcohol consumption from 48 hours prior to each dosing until discharged from the clinical research unit (CRU)

Primary outcomes:
measure: Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]
timeFrame: Predose up to 24 hours after administration of study drug
measure: Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)
timeFrame: Predose up to 24 hours after administration of study drug
Secondary outcomes:
measure: Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus
timeFrame: Predose up to 24 hours after administration of study drug
measure: Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus
timeFrame: Predose up to 24 hours after administration of study drug
measure: Maximum Glucose Infusion Rate (Rmax)
timeFrame: Postdose up to 24 hours after administration of study drug
measure: Total Amount of Glucose Infused (Gtot)
timeFrame: Postdose up to 24 hours after administration of study drug
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: