Study of LY3039478 in Healthy Participants

NCT ID: NCT02906618

Last Updated: 2025-07-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-04

Study Completion Date

2016-11-11

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3039478 - Oral

LY3039478 given once, orally

Group Type EXPERIMENTAL

LY3039478

Intervention Type DRUG

Administered orally

13C 15N 2H-LY3039478 - IV

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

Group Type EXPERIMENTAL

13C 15N 2H-LY3039478 IV

Intervention Type DRUG

Administered IV

Interventions

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LY3039478

Administered orally

Intervention Type DRUG

13C 15N 2H-LY3039478 IV

Administered IV

Intervention Type DRUG

Eligibility Criteria

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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\- Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

Countries

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United Kingdom

Other Identifiers

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I6F-MC-JJCG

Identifier Type: OTHER

Identifier Source: secondary_id

2016-001073-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16344

Identifier Type: -

Identifier Source: org_study_id

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