A Study of LY3214996 in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04033341
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.3
• Patients Per Site Per Month: 4.7

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 will involve a single dose of 14C radiolabelled LY3214996. This means that a radioactive substance, C14, will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to six weeks.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3214996; Drug: [14C]-LY3214996	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Disposition of [14C]-LY3214996 Following Oral Administration in Healthy Male Subjects
• Actual Study Start Date: Aug 1, 2019
• Actual Primary Completion Date: Sep 9, 2019
• Actual Study Completion Date: Sep 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3214996 + [14C]-LY3214996 A single dose of LY3214996 and [14C]-LY3214996 administered orally.	Drug: LY3214996; Administered orally; Drug: [14C]-LY3214996; Administered orally

Outcome Measures

Primary Outcome Measures

1. Urinary Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered [Baseline through Day 8 after administration of study drug]

   Urinary Excretion of LY3214996 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

2. Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered [Baseline through Day 8 after administration of study drug]

   Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

Secondary Outcome Measures

1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3214996 [Predose through Day 8 after administration of study drug]

   PK: Cmax of LY3214996

2. PK: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3214996 [Predose through Day 8 after administration of study drug]

   PK: AUC(0-∞) of LY3214996

3. Total Number of Metabolites of LY3214996 [Baseline through 48 hours after administration of study drug]

   Total Number of Metabolites of LY3214996

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Overtly health males

• Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria:

• Females

• Male participants sexually active with a pregnant partner

• Are currently enrolled in a clinical study or have participated, within the last 30 days, in a clinical study

• Have participated in a radiolabeled drug study within the previous 4 months

• Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders

• Have a history of Gilbert's syndrome

• Have history or presence of psychiatric disorders

• Show evidence of human immunodeficiency virus (HIV) infection

• Show evidence of hepatitis C

• Show evidence of hepatitis B

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research 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: NCT04033341
• Other Study ID Numbers: 17199; I8S-MC-JUAD
• First Posted: Jul 26, 2019
• Last Update Posted: Oct 29, 2019
• Last Verified: Oct 1, 2019

• 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

Study Results

No Results Posted as of Oct 29, 2019