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OpenTrials
Completed

NCT Number: NCT03913260

A Study of Different Injectable Formulations of LY3375880 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Inc, Daytona Beach, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3375880

Drug

Administered SC

Buffer Matrix (No LY3375880)

Drug

Administered SC

Autoinjector (AI)

Device

AI used to administer LY3375880 or Buffer Matrix

Manual Syringe

Device

Manual syringe used to inject LY3375880

Primary outcomes

  1. Visual Analog Scale (VAS) Pain Score

    Time frame: Part A: Within 1-minute post injection

    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).

  2. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3375880

    Time frame: Part B: Predose through Day 85

    PK: Cmax of LY3375880

  3. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880

    Time frame: Part B: Predose through Day 85

    PK: AUC of LY3375880

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 12, 2019
Registry last updated
Oct 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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