A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants

Sponsor
Eli Lilly and Company
Study ID
NCT04004988
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Tirzepatide — DRUG
    Administered SC
  • Prefilled syringe (PFS) — DEVICE
    PFS used to administer tirzepatide
  • Auto-injector (AI) — DEVICE
    AI used to administer tirzepatide

Study Details

The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via an autoinjector versus a conventional prefilled syringe. The tolerability of tirzepatide will also be evaluated and information about any adverse effects experienced will be collected. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 14 weeks, including screening.

Key Dates

Start date
Aug 19, 2019
Status verified
Apr 2023
Primary completion
Dec 16, 2019
Completion
Dec 16, 2019

Study Design

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

Arms

  • Experimental: Tirzepatide Test
    Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection (SC) via an autoinjector (AI) in one of two study periods.
  • Experimental: Tirzepatide Reference
    Participants received single dose of 5mg Tirzepatide by subcutaneous injection (SC) via a prefilled syringe (PFS) in one of two study periods.

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf) [ Time Frame: Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose ]

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