A Study of Dulaglutide in Healthy Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03363906
• Other study ID #: 16878
• Secondary ID: H9X-MC-GBGM
• Status: Completed
• Phase: Phase 1
• Start date: December 7, 2017
• Est. completion date: June 6, 2018

Study information

• Verified date: July 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 6, 2018
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Dulaglutide (Reference)
Administered SC
• Dulaglutide (Test)
Administered SC

Locations

Country	Name	City	State
United States	Covance Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of Dulaglutide	Pharmacokinetics was assessed in healthy participants to determine the area under the concentration time curve from 0 to infinity (AUC[0-8]) of Dulaglutide.	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
Primary	PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide	Pharmacokinetics was assessed in healthy participants to determine the maximum observed drug concentration (Cmax) of Dulaglutide.	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