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A Study of Dulaglutide in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03363906
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

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 : 24 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Drug Information available for: Dulaglutide

Arm Intervention/treatment
Experimental: Dulaglutide (Reference)
Dulaglutide administered subcutaneously (SC) in 3 prefilled syringes in one of two study periods
Drug: Dulaglutide (Reference)
Administered SC
Other Name: LY2189265

Experimental: Dulaglutide (Test)
Dulaglutide administered SC in 1 single dose pen in one of two study periods
Drug: Dulaglutide (Test)
Administered SC
Other Name: LY2189265




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Dulaglutide [ Time Frame: Predose through 15 days post dose ]
    PK: AUC of Dulaglutide

  2. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Dulaglutide [ Time Frame: Predose through 15 days post dose ]
    PK: Cmax of Dulaglutide



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overtly healthy as determined by medical history and physical examination at time of screening
  • Have a body mass index of greater than or equal to (≥) 23 kilograms per meter squared (kg/m²) inclusive

Exclusion Criteria:

  • Have known allergies to dulaglutide, glucagon-like peptide-1 (GLP-1) related compounds, or any components of the formulation
  • Have family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
  • Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or gastrointestinal disorder (e.g., relevant esophageal reflux or gall bladder disease) or any gastrointestinal disease which impacts gastric emptying (e.g., gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1 analogs

Information from the National Library of Medicine

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


Locations
United States, Texas
Covance Dallas
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03363906     History of Changes
Other Study ID Numbers: 16878
H9X-MC-GBGM ( Other Identifier: Eli Lilly and Company )
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dulaglutide
Immunoglobulin Fc Fragments
Hypoglycemic Agents
Physiological Effects of Drugs
Immunologic Factors