Study of LY3039478 in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT02906618

Collaborator

(none)

Enrollment

Location

Arms

1.2

Actual Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3039478 Drug: 3C 15N 2H-LY3039478 IV	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

An Absolute Bioavailability Study of LY3039478 in Healthy Subjects Using the Intravenous Tracer Method

Actual Study Start Date :

Oct 4, 2016

Actual Primary Completion Date :

Nov 11, 2016

Actual Study Completion Date :

Nov 11, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3039478 - Oral LY3039478 given once, orally	Drug: LY3039478 Administered orally
Experimental: 13C 15N 2H-LY3039478 - IV 13C 15N 2H-LY3039478 given once, IV	Drug: 3C 15N 2H-LY3039478 IV Administered IV

Arm

Intervention/Treatment

Experimental: LY3039478 - Oral

LY3039478 given once, orally

Drug: LY3039478

Administered orally

Experimental: 13C 15N 2H-LY3039478 - IV

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

Drug: 3C 15N 2H-LY3039478 IV

Administered IV

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

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.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT02906618

Other Study ID Numbers:

16344
I6F-MC-JJCG
2016-001073-33

First Posted:

Sep 20, 2016

Last Update Posted:

Jan 25, 2017

Last Verified:

Jan 1, 2017

Study Results

No Results Posted as of Jan 25, 2017