A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices

Part of paid clinical trials in Miami, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT06003465
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • LY3437943 — DRUG
    Administered SC
  • Test — DEVICE
    Used to administer LY3437943 SC
  • Reference — DEVICE
    Used to administer LY3437943 SC

Study Details

The main purpose of this study is to look at the amount of the study drug, LY3437943, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of LY3437943 and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 16 weeks, including screening.

Key Dates

Start date
Aug 29, 2023
Status verified
Mar 2024
Primary completion
Feb 8, 2024
Completion
Feb 8, 2024

Study Design

Enrollment
57 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: LY3437943 - Test
    A single dose of LY3437943 administered by subcutaneous (SC) injection via a test device (test formulation)
  • Active Comparator: LY3437943 - Reference
    A single dose of LY3437943 administered by SC injection via a reference device (reference formulation)

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943 [ Time Frame: Predose up to 43 days postdose ]

Locations (3)

FacilityCityStateZIPSite coordinators
Qps-Mra, LlcMiamiFlorida33143-4875-
ICON Early Phase ServicesSan AntonioTexas78209-
ICONSalt Lake CityUtah84124-

Find similar trials in Miami, FL

By research site
Qps-Mra, Llc· Miami, FLICON Early Phase Services· San Antonio, TXICON· Salt Lake City, UT

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