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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04991766
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.6
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: [¹⁴C]-LY3484356; Drug: LY3484356; Drug: [¹⁴C]-LY3484356 (IV)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: An Open-label, Two-part Study of the Disposition and Absolute Bioavailability of [¹⁴C]-LY3484356 in Healthy Females of Non-Childbearing Potential
• Actual Study Start Date: Aug 13, 2021
• Actual Primary Completion Date: Apr 2, 2022
• Actual Study Completion Date: Apr 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [¹⁴C]-LY3484356 (Part 1) Single dose of [¹⁴C]-LY3484356 administered orally.	Drug: [¹⁴C]-LY3484356; Administered orally.
Experimental: LY3484356 + [¹⁴C]-LY3484356 (Part 2) Single dose of LY3484356 administered orally followed by Single dose of [¹⁴C]-LY3484356 administered intravenously (IV).	Drug: LY3484356; Administered orally.; Drug: [¹⁴C]-LY3484356 (IV); Administered IV.

Outcome Measures

Primary Outcome Measures

1. Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [Predose up to Day 12 post dose]

   Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

2. Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [Predose up to Day 12 post dose]

   Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

3. Pharmacokinetics (PK): Absolute Bioavailability of LY3484356 [Predose up to Day 9 post dose]

   PK: Absolute Bioavailability of LY3484356

Secondary Outcome Measures

1. PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-∞)) of Total Radioactivity, LY3484356 and [¹⁴C]-LY3484356 [Predose up to Day 12 post dose]

   PK: (AUC (0-∞)) of Total Radioactivity, LY3484356 and [¹⁴C]-LY3484356

2. PK: Maximum Concentration (Cmax) of Total Radioactivity, LY3484356 and [¹⁴C]-LY3484356 [Predose up to Day 12 post dose]

   PK: Cmax of Total Radioactivity, LY3484356 and [¹⁴C]-LY3484356

3. Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable). [Predose up to Day 12 post dose]

   Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable).

4. Total Number of Metabolites of LY3484356 [Predose up to Day 12 post dose]

   Total Number of Metabolites of LY3484356

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LabCorp CRU, Inc.	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT04991766
• Other Study ID Numbers: 18205; J2J-MC-JZLE
• First Posted: Aug 5, 2021
• Last Update Posted: May 2, 2022
• Last Verified: Apr 15, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eli Lilly and Company: Metabolism; Absolute Bioavailability; Disposition

Study Results

No Results Posted as of May 2, 2022