Phase 1
N=16
A Study of [¹⁴C]-LY3484356 in Healthy Female Participants
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04991766 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Part 1: Pharmacokinetics (PK): Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered — 97.3 percentage of the total radioactive dose
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- [¹⁴C]-LY3484356 (Drug); LY3484356 (Drug); [¹⁴C]-LY3484356 (IV) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Eli Lilly and Company
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Pharmacokinetics (PK): Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
97.3 | — |
| PRIMARY Part 1: PK: Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
0.278 | — |
| PRIMARY Part 2: Pharmacokinetics (PK): Percent Absolute Bioavailability (F%) of LY3484356 |
10.5 | — |
| SECONDARY Part 1: PK: Total Radioactivity Recovered in Urine, Feces |
0.278; 97.3 | — |
| SECONDARY Part 1: Total Radioactivity Recovered in Expired Air |
53; 62 | — |
| SECONDARY Part 1: PK: Total Number of Metabolites of LY3484356 in Plasma, Urine and Feces |
3; 0; 7 | — |
| SECONDARY Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for LY3484356 in Plasma |
3130 | — |
| SECONDARY Part 1: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma |
17900 | — |
| SECONDARY Part 1: PK: Maximum Concentration (Cmax) for LY3484356 in Plasma |
108 | — |
| SECONDARY Part 1: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma |
537 | — |
| SECONDARY Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for [¹⁴C]-LY3484356 and LY3484356 in Plasma |
1.95; 1810 | — |
| SECONDARY Part 2: PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC [0-∞]) for Total Radioactivity in Plasma |
7.44 | — |
| SECONDARY Part 2: PK: Maximum Concentration (Cmax) for [¹⁴C]-LY3484356 and LY3484356 in Plasma |
0.575; 33.1 | — |
| SECONDARY Part 2: PK: Maximum Concentration (Cmax) for Total Radioactivity in Plasma |
0.857 | — |
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
Data sourced from ClinicalTrials.gov (NCT04991766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.