A Study of LY2963016 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

Pharmacokinetics and Pharmacodynamics of LY2963016 Compared to Lantus® in Healthy Subjects Following Two Single Subcutaneous Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01634165
• Other study ID #: 14676
• Secondary ID: I4L-MC-ABEM
• Status: Completed
• Phase: Phase 1
• First received: July 2, 2012
• Last updated: October 3, 2014
• Start date: July 2012
• Est. completion date: September 2012

Study information

• Verified date: October 2014
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSingapore: Domain Specific Review BoardsSingapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY2963016
Administered subcutaneously
• Lantus
Administered subcutaneously

Locations

Country	Name	City	State
Singapore	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.	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-8)]	Results for LY2936016 treatment arms provide the AUC(0-8) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-8) for Lantus.	Predose up to 24 hours after administration of study drug	No
Primary	Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)		Predose up to 24 hours after administration of study drug	No
Secondary	Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus	Results for LY2936016 treatment arms provide the AUC(0-24) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-24) for Lantus.	Predose up to 24 hours after administration of study drug	No
Secondary	Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus	Results for LY2936016 treatment arms provide the AUC(0-tlast) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-tlast) for Lantus.	Predose up to 24 hours after administration of study drug	No
Secondary	Maximum Glucose Infusion Rate (Rmax)	Rmax is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.	Postdose up to 24 hours after administration of study drug	No
Secondary	Total Amount of Glucose Infused (Gtot)	Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.	Postdose up to 24 hours after administration of study drug	No