A Study of Lispro Formulations in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Lispro

• Registration Number: NCT02293551
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-13
• Study First Posted: 2014-11-18
• Study Start: 2014-12
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-08
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part A: Lispro (C)	Lispro	Formulation C: Single dose of lispro administered SC in one of five periods.
Part A: Lispro (D)	Lispro	Formulation D: Single dose of lispro administered SC in one of five periods.
Part A: Lispro (A)	Lispro	Formulation A: Single dose of lispro administered subcutaneously (SC) in one of five periods.
Part A: Lispro (B)	Lispro	Formulation B: Single dose of lispro administered SC in one of five periods.
Part A: Lispro (Reference)	Lispro	Reference formulation: Single dose of lispro administered SC in one of five periods.
Part B: Lispro	Lispro	Formulation selected from Part A. Single dose of lispro administered SC in one of four periods.

Primary Outcome Measures

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

Trial Locations

Locations (1)

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.; 🇸🇬 Singapore, Singapore