A Study of Dulaglutide in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/22/2018 |
| Start Date: | December 7, 2017 |
| End Date: | June 6, 2018 |
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
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).
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).
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
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