Clinical trial NCT01638325: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Adocia
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2012-07-11
Enrollment: 37
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: 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.


Eligibility criteria: 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), 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 milliliters (mL) 3 months prior to study enrollment

Primary outcomes:
measure: Pharmacokinetics: Area under the concentration curve (AUC)
timeFrame: Baseline up to 8 hours post administration of study drug
measure: Pharmacokinetics: Maximum concentration (Cmax)
timeFrame: Baseline up to 8 hours post administration of study drug
measure: Pharmacokinetics: Time of maximum concentration (Tmax)
timeFrame: Baseline up to 8 hours post administration of study drug
Secondary outcomes:
measure: Glucodynamic response: Time to maximum infusion rate (tRmax) during euglycemic clamps of BC106 insulin lispro
timeFrame: Baseline up to 30 days
measure: Pharmacokinetics: Within-participant variability of time to maximum drug concentration (tmax) of BC106 insulin lispro
timeFrame: Baseline up to 30 days
measure: Glucodynamic within-participant variability of time to maximum glucose infusion rate (tRmax) for BC106 insulin lispro
timeFrame: Baseline up to 30 days
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: