A Study of Lispro Formulations in Healthy Participants

September 8, 2015 updated by: Eli Lilly and Company

Safety, Tolerability, and Pharmacokinetics of Multiple Novel Insulin Lispro Formulations

The purposes of this study are to determine:

  • Part A

    • How quickly your body absorbs, breaks down and gets rid of the different formulations of insulin lispro compared to insulin lispro alone formulation.
    • The safety of insulin lispro in different formulations and any side effects that might be associated with it.

  • Part B:

    • How much insulin lispro from different dose ranges is found in the bloodstream using a test insulin lispro formulation (selected from Part A).
    • The safety of insulin lispro in different formulations and any side effects that might be associated with it.

Participants may only enroll in one part. The study is expected to last up to 10 weeks for each part.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Overtly healthy males or females (nonchildbearing potential and with absent cyclical hormonal changes), as determined by medical history and physical examination

Exclusion Criteria:

- Have a fasting plasma glucose less than or equal to (≤) 4.0 millimole per liter (mmol/L) at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Lispro (A)
Formulation A: Single dose of lispro administered subcutaneously (SC) in one of five periods.
Drug: Lispro
Administered SC
Other Names:
  • LY275585
Experimental: Part A: Lispro (B)
Formulation B: Single dose of lispro administered SC in one of five periods.
Drug: Lispro
Administered SC
Other Names:
  • LY275585
Experimental: Part A: Lispro (C)
Formulation C: Single dose of lispro administered SC in one of five periods.
Drug: Lispro
Administered SC
Other Names:
  • LY275585
Experimental: Part A: Lispro (D)
Formulation D: Single dose of lispro administered SC in one of five periods.
Drug: Lispro
Administered SC
Other Names:
  • LY275585
Experimental: Part A: Lispro (Reference)
Reference formulation: Single dose of lispro administered SC in one of five periods.
Drug: Lispro
Administered SC
Other Names:
  • LY275585
Experimental: Part B: Lispro
Formulation selected from Part A. Single dose of lispro administered SC in one of four periods.
Drug: Lispro
Administered SC
Other Names:
  • LY275585

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A and B: Pharmacokinetics: Area Under The Concentration Curve (AUC) of LY275585
Time Frame: Predose through day 1 in each period
Predose through day 1 in each period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

November 13, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 18, 2014

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 8, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15626
  • F3Z-FW-ITCA (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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