Clinical trial NCT04991766: A Study of [¹⁴C]-LY3484356 in Healthy Female Participants
Official title: An Open-label, Two-part Study of the Disposition and Absolute Bioavailability of [¹⁴C]-LY3484356 in Healthy Females of Non-Childbearing Potential
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Metabolism
Absolute Bioavailability
Disposition
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Predose up to Day 12 post dose
measure: Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Predose up to Day 12 post dose
measure: Pharmacokinetics (PK): Absolute Bioavailability of LY3484356
timeFrame: Predose up to Day 9 post dose
Secondary outcomes:
measure: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-∞)) of Total Radioactivity, LY3484356 and [¹⁴C]-LY3484356
timeFrame: Predose up to Day 12 post dose
measure: PK: Maximum Concentration (Cmax) of Total Radioactivity, LY3484356 and [¹⁴C]-LY3484356
timeFrame: Predose up to Day 12 post dose
measure: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable).
timeFrame: Predose up to Day 12 post dose
measure: Total Number of Metabolites of LY3484356
timeFrame: Predose up to Day 12 post dose
Other outcomes:
Locations:
city: Madison
country: United States
facility: LabCorp CRU, Inc.
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: