Study of LY3039478 in Healthy Participants
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02906618
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this study will help to answer the following research questions:
* How much LY3039478 gets into the blood stream when given by mouth as a capsule compared to when given by an IV
* How long it takes the body to remove the study drug
* The safety of LY3039478 and any side effects that might be associated with it
Participation in the study is expected to last up to 7 weeks. There will be screening, a single study period, and a follow-up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²) inclusive
- Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product
• Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy in the opinion of the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LY3039478 - Oral LY3039478 LY3039478 given once, orally 13C 15N 2H-LY3039478 - IV 13C 15N 2H-LY3039478 IV 13C 15N 2H-LY3039478 given once, IV LY3039478 - Oral LY3039478 LY3039478 given once, orally 13C 15N 2H-LY3039478 - IV 3C 15N 2H-LY3039478 IV 13C 15N 2H-LY3039478 given once, IV
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478 Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose Pharmacokinetics (PK) is the area under the concentration versus time curve (AUC) from time zero to the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3039478 and 13C 15N 2H-LY3039478.
PK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY3039478 Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose PK is AUC from zero to infinity (AUC\[0 - inf\]) of LY3039478 and 13C 15N 2H-LY3039478.
- Secondary Outcome Measures
Name Time Method PK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478 Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose PK is the half life associated with the terminal rate constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478.
PK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IV Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose PK is the maximum observed drug concentration (cmax) of LY3039478 13C 15N 2H-LY3039478 - IV.
PK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY3039478 Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose PK is the time of Cmax (tmax) of LY3039478 and 13C 15N 2H-LY3039478.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
🇬🇧Leeds, United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.🇬🇧Leeds, United Kingdom