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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-13

Study Completion Date

2022-04-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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[¹⁴C]-LY3484356 (Part 1)

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.

Group Type EXPERIMENTAL

[¹⁴C]-LY3484356

Intervention Type DRUG

Administered orally.

LY3484356 + [¹⁴C]-LY3484356 (Part 2)

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.

Group Type EXPERIMENTAL

LY3484356

Intervention Type DRUG

Administered orally.

[¹⁴C]-LY3484356 (IV)

Intervention Type DRUG

Administered IV.

Interventions

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[¹⁴C]-LY3484356

Administered orally.

Intervention Type DRUG

LY3484356

Administered orally.

Intervention Type DRUG

[¹⁴C]-LY3484356 (IV)

Administered IV.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes