Study of LY3039478 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3039478; Drug: 3C 15N 2H-LY3039478 IV

• 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

Study Timeline

• Study First Submitted: 2016-09-15
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-20
• Study Start: 2016-10-04
• Primary Completion: 2016-11-11
• Study Completion: 2016-11-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²) inclusive

Read More

Exclusion Criteria

• Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product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

Read More

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	3C 15N 2H-LY3039478 IV	13C 15N 2H-LY3039478 given once, IV

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: 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 3C 15N 2H-LY3039478	Predose through 48 hours after administration of study drug
Pharmacokinetics: AUC from Zero to Infinity (AUC[0 - inf]) of LY3039478 and 3C 15N 2H-LY3039478	Predose through 48 hours after administration of study drug

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY3039478	Predose through 48 hours after administration of study drug
Pharmacokinetics: Time of Cmax (tmax) of LY3039478	Predose through 48 hours after administration of study drug
Pharmacokinetics: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478	Predose through 48 hours after administration of study drug

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