A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638325
• Other study ID #: 14771
• Secondary ID: H9D-MC-ITAG
• Status: Completed
• Phase: Phase 1
• First received: July 9, 2012
• Last updated: June 13, 2014
• Start date: July 2012
• Est. completion date: September 2012

Study information

• Verified date: February 2013
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSingapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• 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:

• 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

Study Design

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Insulin Lispro
Administered SC
• BC106 insulin lispro
Administered SC

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 (2)

Lead Sponsor	Collaborator
Adocia	Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area under the concentration curve (AUC)		Baseline up to 8 hours post administration of study drug	No
Primary	Pharmacokinetics: Maximum concentration (Cmax)		Baseline up to 8 hours post administration of study drug	No
Primary	Pharmacokinetics: Time of maximum concentration (Tmax)		Baseline up to 8 hours post administration of study drug	No
Secondary	Glucodynamic response: Time to maximum infusion rate (tRmax) during euglycemic clamps of BC106 insulin lispro		Baseline up to 30 days	No
Secondary	Pharmacokinetics: Within-participant variability of time to maximum drug concentration (tmax) of BC106 insulin lispro		Baseline up to 30 days	No
Secondary	Glucodynamic within-participant variability of time to maximum glucose infusion rate (tRmax) for BC106 insulin lispro		Baseline up to 30 days	No