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

Healthy Clinical Trial

Official title:

An Open-label, Two-part Study of the Disposition and Absolute Bioavailability of [¹⁴C]-LY3484356 in Healthy Females of Non-Childbearing Potential

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04991766
• Other study ID #: 18205
• Secondary ID: J2J-MC-JZLE
• Status: Completed
• Phase: Phase 1
• Start date: August 13, 2021
• Est. completion date: April 2, 2022

Study information

• Verified date: April 15, 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2, 2022
• Est. primary completion date: April 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• [¹4C]-LY3484356
Administered orally.
• LY3484356
Administered orally.
• [¹4C]-LY3484356 (IV)
Administered IV.

Locations

Country	Name	City	State
United States	LabCorp CRU, Inc.	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Predose up to Day 12 post dose
Primary	Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Predose up to Day 12 post dose
Primary	Pharmacokinetics (PK): Absolute Bioavailability of LY3484356	PK: Absolute Bioavailability of LY3484356	Predose up to Day 9 post dose
Secondary	PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-8)) of Total Radioactivity, LY3484356 and [¹4C]-LY3484356	PK: (AUC (0-8)) of Total Radioactivity, LY3484356 and [¹4C]-LY3484356	Predose up to Day 12 post dose
Secondary	PK: Maximum Concentration (Cmax) of Total Radioactivity, LY3484356 and [¹4C]-LY3484356	PK: Cmax of Total Radioactivity, LY3484356 and [¹4C]-LY3484356	Predose up to Day 12 post dose
Secondary	Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable).	Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable).	Predose up to Day 12 post dose
Secondary	Total Number of Metabolites of LY3484356	Total Number of Metabolites of LY3484356	Predose up to Day 12 post dose