A Study of [¹⁴C]-LY3484356 in Healthy Female Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: [¹⁴C]-LY3484356 (IV); Drug: LY3484356; Drug: [¹⁴C]-LY3484356

Study type: Interventional

Funder types: Industry

Identifiers

NCT04991766

J2J-MC-JZLE (Other Identifier)

18205

Details and patient eligibility

About

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study has two parts. It will involve a single dose of 14C radiolabeled LY3484356. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.

Enrollment: 16 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female participants of nonchildbearing potential. This includes females who are not pregnant, non-lactating and either: Infertile due to surgical sterilization or alternate medical cause/congenital or postmenopausal.
• Body mass index (BMI) within the range of 18.0 to 35.0 kilograms per meter squared (kg/m²)

Exclusion criteria

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorders
• Have evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
• Have known allergies to LY3484356, related compounds or any components of the formulation as appropriate, or history of significant atopy

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

[¹⁴C]-LY3484356 (Part 1)

Experimental group

Description:

Participants received a single oral dose of 400 mg Carbon 14 labelled \[¹⁴C\]-LY3484356 following an overnight fast of at least 10 hours on Day 1.

Treatment:

Drug: [¹⁴C]-LY3484356

LY3484356 + [¹⁴C]-LY3484356 (Part 2)

Experimental group

Description:

Participants received a single oral dose of 400 mg LY3484356 following an overnight fast of at least 10 hours on Day 1, followed 4 hours later by a single dose of less than 100 microgram (μg) \[¹⁴C\]-LY3484356 (actual ranged from 44.55 to 45.95 μg), as an intravenous (IV) infusion on day 1.

Treatment:

Drug: LY3484356

Drug: [¹⁴C]-LY3484356 (IV)