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Completed

NCT Number: NCT02906618

Study of LY3039478 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product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

Treatment and study plan

LY3039478

Drug

Administered orally

13C 15N 2H-LY3039478 IV

Drug

Administered IV

Primary outcomes

  1. 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

    Time frame: 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.

  2. PK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY3039478

    Time frame: 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 outcomes

  1. PK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IV

    Time frame: 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.

  2. PK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY3039478

    Time frame: 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.

  3. PK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 20, 2016
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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