Study of LY3039478 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 13C 15N 2H-LY3039478 IV; Drug: LY3039478

Study type: Interventional

Funder types: Industry

Identifiers

NCT02906618

I6F-MC-JJCG (Other Identifier)

2016-001073-33 (EudraCT Number)

16344

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

LY3039478 - Oral

Experimental group

Description:

LY3039478 given once, orally

Treatment:

Drug: LY3039478

13C 15N 2H-LY3039478 - IV

Experimental group

Description:

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

Treatment:

Drug: 13C 15N 2H-LY3039478 IV