A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices
Study Details
Study Description
Brief Summary
The main purpose of this study is to look at the amount of the study drug, LY3437943, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of LY3437943 and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 16 weeks, including screening.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY3437943 - Test A single dose of LY3437943 administered by subcutaneous (SC) injection via a test device (test formulation) |
Drug: LY3437943
Administered SC
Device: Test
Used to administer LY3437943 SC
|
| Active Comparator: LY3437943 - Reference A single dose of LY3437943 administered by SC injection via a reference device (reference formulation) |
Drug: LY3437943
Administered SC
Device: Reference
Used to administer LY3437943 SC
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943 [Predose up to 43 days postdose]
PK: Cmax of LY3437943
- PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of LY3437943 [Predose up to 43 days postdose]
PK: AUC[0-tlast] of LY3437943
- PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943 [Predose up to 43 days postdose]
PK: AUC(0-∞) of LY3437943
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures
-
Body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive
-
Have clinical laboratory test results, blood pressure and pulse rate that are acceptable for the study
-
Are agreeable to receiving study treatment by injections under the skin
-
Males who agree to use highly effective/effective methods of contraception and women not of childbearing potential (postmenopausal or oophorectomized)
Exclusion Criteria:
-
Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
-
Smoke more than the equivalent of 10 cigarettes per day
-
Is a known user of drugs of abuse
-
Have known allergies to LY3437943 or related compounds
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qps-Mra, Llc | Miami | Florida | United States | 33143 |
| 2 | ICON Early Phase Services | San Antonio | Texas | United States | 78209 |
| 3 | ICON | Salt Lake City | Utah | United States | 84124 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18530
- J1I-MC-GZBX