A Study of LY2963016 in Healthy Participants | RxWiki

A Study of LY2963016 in Healthy Participants

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Healthy Volunteers
Intervention	Drug: LY2963016 Drug: Lantus
Phase	Phase 1
Sponsor	Eli Lilly and Company
Responsible Party	Eli Lilly and Company
ClinicalTrials.gov Identifier	NCT01634165
First Received	July 2, 2012
Last Updated	September 28, 2012
Last verified	September 2012

Tracking Information[ + expand ][ + ]

First Received Date	July 2, 2012
Last Updated Date	September 28, 2012
Start Date	July 2012
Estimated Primary Completion Date	September 2012
Current Primary Outcome Measures	Pharmacokinetics: Area under the serum LY2963016 or Lantus concentration-time curve (AUC) from zero to infinity (AUC[0-∞]) [Time Frame: Up to 24 hours after administration of study drug] [Designated as safety issue: No] Pharmacokinetics: Maximum serum LY2963016 or Lantus concentration (CMax) [Time Frame: Up to 24 hours after administration of study drug] [Designated as safety issue: No]
Current Secondary Outcome Measures	Pharmacokinetics: AUC from time zero to last measured concentration value (AUC[0-tlast]) of LY2963016 or Lantus [Time Frame: Up to 24 hours after administration of study drug] [Designated as safety issue: No] Pharmacokinetics: AUC from time zero to 24 hours (AUC[0-24]) of LY2963016 or Lantus [Time Frame: Up to 24 hours after administration of study drug] [Designated as safety issue: No] Maximum glucose infusion rate (Rmax) [Time Frame: Up to 24 hours after administration of study drug] [Designated as safety issue: No] Total amount of glucose infused (Gtot) [Time Frame: Up to 24 hours after administration of study drug] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	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
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Condition	Healthy Volunteers
Intervention	Drug: LY2963016 Administered SQ Drug: Lantus Administered SQ
Study Arm (s)	Experimental: 0.3 U/kg LY2963016 Single 0.3 units/kilogram (U/kg) subcutaneous (SQ) dose of LY2963016 Experimental: 0.3 U/kg Lantus Single 0.3 U/kg SQ dose of Lantus Experimental: 0.6 U/kg LY2963016 Single 0.6 U/kg SQ dose of LY2963016 Experimental: 0.6 U/kg Lantus Single 0.6 U/kg SQ dose of Lantus

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	28
Estimated Completion Date	September 2012
Estimated Primary Completion Date	September 2012
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/m^2) - 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)
Gender	Both
Ages	21 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Singapore

Administrative Information[ + expand ][ + ]

NCT Number	NCT01634165
Other Study ID Numbers	14676
Has Data Monitoring Committee	No
Information Provided By	Eli Lilly and Company
Study Sponsor	Eli Lilly and Company
Collaborators	Not Provided
Investigators	Study Director: 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) Eli Lilly and Company
Verification Date	September 2012

Locations[ + expand ][ + ]

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, Singapore, 117597