A Study of Different Injectable Formulations of LY3375880 in Healthy Participants

Healthy Clinical Trial

Official title:

A Safety, Tolerability, and Pharmacokinetic Study of Different Solution Formulations of LY3375880 Using Investigational Injection Devices in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03913260
• Other study ID #: 17212
• Secondary ID: I9N-MC-FCAC
• Status: Completed
• Phase: Phase 1
• Start date: May 1, 2019
• Est. completion date: September 19, 2019

Study information

• Verified date: October 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purposes of this study are: 1. To learn more about the safety and side effects of different formulations of LY3375880 and 2. To measure how much LY3375880 gets into the blood stream and how long it takes to get out of the body. The study will last about 85 days. Screening may occur up to 28 days prior to enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: September 19, 2019
• Est. primary completion date: September 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Are overtly healthy males or females, as determined by medical history and physical examination

• Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive

• Females who are not of child-bearing potential

• Males who agree to use a reliable method of birth control during the study and for 120 days following the final administration of LY3375880

• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

• Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy

• Have participated or are currently enrolled in clinical trials with LY3375880

• Have infections or evidence of infections

• Are pregnant, lactating or breast feeding

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3375880
Administered SC
• Buffer Matrix (No LY3375880)
Administered SC

Device:
• Autoinjector (AI)
AI used to administer LY3375880 or Buffer Matrix
• Manual Syringe
Manual syringe used to inject LY3375880

Locations

Country	Name	City	State
United States	Covance	Dallas	Texas
United States	Covance Clinical Research Inc	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS) Pain Score	The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain).	Part A: Within 1-minute post injection
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3375880	PK: Cmax of LY3375880	Part B: Predose through Day 85
Primary	PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880	PK: AUC of LY3375880	Part B: Predose through Day 85