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A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants

Information source: Adocia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Participants

Intervention: Insulin Lispro (Drug); BC106 insulin lispro (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Adocia

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company


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.

Clinical Details

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

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

Primary outcome:

Pharmacokinetics: Area under the concentration curve (AUC)

Pharmacokinetics: Maximum concentration (Cmax)

Pharmacokinetics: Time of maximum concentration (Tmax)

Secondary outcome:

Glucodynamic response: Time to maximum infusion rate (tRmax) during euglycemic clamps of BC106 insulin lispro

Pharmacokinetics: Within-participant variability of time to maximum drug concentration (tmax) of BC106 insulin lispro

Glucodynamic within-participant variability of time to maximum glucose infusion rate (tRmax) for BC106 insulin lispro


Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- Are not of child-bearing potential

- Have a body mass index (BMI) between 18 and 29. 9 kilograms per square meter (kg/m^2),


- 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 milliliters (mL) 3 months prior to study


Locations and Contacts

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 117597, Singapore
Additional Information

Starting date: July 2012
Last updated: June 13, 2014

Page last updated: August 23, 2015

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