A Study of Lispro Formulations in Healthy Participants

Eli Lilly and Company54 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: \- Overtly healthy males or females (non-childbearing 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

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

Outcomes

Primary Outcomes

Part A and Part B: Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞])

Primary outcome measure is based on the PK area under the concentration curve from 0 to infinity with a measurable concentration.

Time frame: -30, 0 (Predose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, and 300 Minutes