A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants | RxWiki

A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants

Overview[ - collapse ][ - ]

Purpose	BC106 is a molecule that when injected with insulin lispro may change the speed of absorption of insulin lispro. The purpose of this study will be to evaluate the safety of BC106 insulin lispro and any side effects that might be associated with it, blood levels of insulin lispro after injection under the skin and how BC106 insulin lispro affects blood sugar after injection under the skin. There is a minimum 7 day washout between single doses.
Condition	Healthy Volunteers
Intervention	Drug: Insulin Lispro Drug: BC106
Phase	Phase 1
Sponsor	Eli Lilly and Company
Responsible Party	Eli Lilly and Company
ClinicalTrials.gov Identifier	NCT01638325
First Received	July 9, 2012
Last Updated	February 7, 2013
Last verified	February 2013

Tracking Information[ + expand ][ + ]

First Received Date	July 9, 2012
Last Updated Date	February 7, 2013
Start Date	July 2012
Estimated Primary Completion Date	September 2012
Current Primary Outcome Measures	Pharmacokinetics: Area under the concentration curve (AUC) [Time Frame: Baseline up to 8 hours post administration of study drug] [Designated as safety issue: No] Pharmacokinetics: Maximum concentration (Cmax) [Time Frame: Baseline up to 8 hours post administration of study drug] [Designated as safety issue: No] Pharmacokinetics: Time of maximum concentration (Tmax) [Time Frame: Baseline up to 8 hours post administration of study drug] [Designated as safety issue: No]
Current Secondary Outcome Measures	Glucodynamic response: Time to maximum infusion rate (tRmax) during euglycemic clamps of BC106 insulin lispro [Time Frame: Baseline up to 30 days] [Designated as safety issue: No] Pharmacokinetics: Within-participant variability of time to maximum drug concentration (tmax) of BC106 insulin lispro [Time Frame: Baseline up to 30 days] [Designated as safety issue: No] Glucodynamic within-participant variability of time to maximum glucose infusion rate (tRmax) for BC106 insulin lispro [Time Frame: Baseline up to 30 days] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants
Official Title	A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of Single Subcutaneous Injections of Insulin Lispro With BioChaperone Excipient in Healthy Volunteers
Brief Summary	BC106 is a molecule that when injected with insulin lispro may change the speed of absorption of insulin lispro. The purpose of this study will be to evaluate the safety of BC106 insulin lispro and any side effects that might be associated with it, blood levels of insulin lispro after injection under the skin and how BC106 insulin lispro affects blood sugar after injection under the skin. There is a minimum 7 day washout between single doses.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Condition	Healthy Volunteers
Intervention	Drug: Insulin Lispro Administered subcutaneously (SQ) Other Names: Humalog LY275585 Drug: BC106 Administered subcutaneously (SQ)
Study Arm (s)	Active Comparator: Insulin Lispro 15 IU insulin lispro administered once subcutaneously (SQ) during 1 of 3 dosing periods. There is a minimum 3 day washout between dosing periods. Experimental: BC106 Insulin Lispro 15 up to 30 IU BC106 insulin lispro administered once SQ during 2 of 3 dosing periods. There is a minimum 7 day washout between dosing periods.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	108
Estimated Completion Date	September 2012
Estimated Primary Completion Date	September 2012
Eligibility Criteria	Inclusion Criteria: - Are not of child-bearing potential - Have a body mass index (BMI) between 18 and 29.9 kilograms per meter squared (kg/m^2), inclusive - Are nonsmokers or have not smoked for at least 6 months prior to entering the study - Have a fasting plasma glucose less than 6.0 millimoles per Liter (mmol/L) at screening Exclusion Criteria: - Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin including allergies to dextrans - Have a history of first-degree relatives known to have diabetes mellitus - Have used systemic glucocorticoids within 3 months prior to entry into the study - Have donated or had a blood loss of 450 milliliter (mL) 3 months prior to study enrollment
Gender	Both
Ages	21 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Singapore

Administrative Information[ + expand ][ + ]

NCT Number	NCT01638325
Other Study ID Numbers	14771
Has Data Monitoring Committee	No
Information Provided By	Eli Lilly and Company
Study Sponsor	Eli Lilly and Company
Collaborators	Adocia
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	February 2013

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