A Study of Dulaglutide in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT03363906|
Recruitment Status : Completed
First Posted : December 6, 2017
Results First Posted : July 29, 2019
Last Update Posted : July 29, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Dulaglutide (Reference) Drug: Dulaglutide (Test)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Relative Bioavailability of an Investigational Single Dose of Dulaglutide After Subcutaneous Administration by a Single Dose Pen Compared to a Prefilled Syringe in Healthy Subjects|
|Actual Study Start Date :||December 7, 2017|
|Actual Primary Completion Date :||June 6, 2018|
|Actual Study Completion Date :||June 6, 2018|
Experimental: Dulaglutide (Reference)
Dulaglutide 4.5 mg administered subcutaneously (SC) in 3 prefilled syringes (PFS) in one of two study periods
Drug: Dulaglutide (Reference)
Other Name: LY2189265
Experimental: Dulaglutide (Test)
Dulaglutide 4.5 mg administered SC in 1 single dose pen (SDP) in one of two study periods
Drug: Dulaglutide (Test)
Other Name: LY2189265
- 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 ]Pharmacokinetics was assessed in healthy participants to determine the area under the concentration time curve from 0 to infinity (AUC[0-∞]) of Dulaglutide.
- PK: Maximum Observed Drug Concentration (Cmax) 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 ]Pharmacokinetics was assessed in healthy participants to determine the maximum observed drug concentration (Cmax) of Dulaglutide.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363906
|United States, Texas|
|Dallas, Texas, United States, 75247|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|