A Study of Dulaglutide in Healthy Participants

Part of paid clinical trials in Dallas, Texas.

Sponsor
Eli Lilly and Company
Study ID
NCT03363906
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to evaluate a new formulation of dulaglutide (study drug) administered under the skin as one injection using a single dose pen compared to three injections using a pre filled syringe. This study will evaluate how much of the study drug enters the body and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The study will last about 84 days, including screening and will require overnight stays in the clinical research unit (CRU).

Key Dates

Start date
Dec 7, 2017
Status verified
Jul 2018
Primary completion
Jun 6, 2018
Completion
Jun 6, 2018

Study Design

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

Arms

  • Experimental: Dulaglutide (Reference)
    Dulaglutide 4.5 mg administered subcutaneously (SC) in 3 prefilled syringes (PFS) in one of two study periods
  • Experimental: Dulaglutide (Test)
    Dulaglutide 4.5 mg administered SC in 1 single dose pen (SDP) in one of two study periods

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide [ Time Frame: Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up: Day 28 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Covance DallasDallasTexas75247-

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