A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Pharmacokinetics of LY2605541 Injection and Insulin Lispro Injection Administered as Mixture or as Individual Components in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871493
• Other study ID #: 14833
• Secondary ID: I6O-FW-BHBA
• Status: Completed
• Phase: Phase 1
• First received: June 4, 2013
• Last updated: October 20, 2014
• Start date: June 2013
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate how the body absorbs and removes LY2605541, insulin lispro, and a mixture of both from the blood. The study has two parts. Participants may enroll in only one part. Each part has four treatment periods in a fixed order. The study will last approximately 8 weeks, not including screening. Screening is required within 28 days prior to the start of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• 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 meter squared (kg/m^2), inclusive

• Are nonsmokers or have not smoked for at least 2 months prior to entering the study

Exclusion Criteria:

• Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin

• 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 blood or had a blood loss of 450 milliliter (mL) within 1 month prior to study enrollment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY2605541
Administered subcutaneous (SQ)
• Insulin Lispro
Administered SQ

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 (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Time to Reach Peak Concentration (tmax) of LY2605541 and Insulin Lispro		Pre-dose up to 216 hours post-dose	No
Primary	Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Lispro		Pre-dose up to 216 hours post-dose	No
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-8) of LY2605541 and Insulin Lispro		Pre-dose up to 216 hours post-dose	No
Secondary	Maximum Glucose Infusion Rate (Rmax)		Predose up to 32 hours post clamp procedure in all treatment periods	No
Secondary	Total Glucose Infused Over Clamp Duration (Gtot)		Predose up to 32 hours post clamp procedure in all treatment periods	No