Phase 1
N=82
A Study of LY3484356 in Healthy Female Participants
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04840888 ↗Enrolled (actual)
82
Serious AEs
0.3%
Results posted
Dec 2025
Primary outcome: Primary: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 (Cohort 1) — 1810; 4350 nanogram*hour per milliliter (ng*hr/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LY3484356 (Drug); Omeprazole (Drug); Itraconazole (Drug); Carbamazepine (Drug); Midazolam (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 Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 (Cohort 1) |
1810; 4350 | — |
| PRIMARY PK: AUC[0-∞] of LY3484356 (Cohort 2) |
2270; 1960 | — |
| PRIMARY PK: AUC[0-∞] of LY3484356 (Cohort 3) |
1430; 3120 | — |
| PRIMARY PK: AUC[0-∞] of LY3484356 (Cohort 4) |
1950; 1090 | — |
| PRIMARY PK: Time of Maximum Observed Concentration (Tmax) of LY3484356 (Cohort 1) |
8.00; 3.02 | — |
| PRIMARY PK: Tmax of LY3484356 (Cohort 2) |
6.02; 6.00 | — |
| PRIMARY PK: Tmax of LY3484356 (Cohort 3) |
6.00; 6.00 | — |
| PRIMARY PK: Tmax of LY3484356 (Cohort 4) |
4.00; 3.87 | — |
| PRIMARY PK: Maximum Observed Concentration (Cmax) of LY3484356 (Cohort 1) |
37.2; 143 | — |
| PRIMARY PK: Cmax of LY3484356 (Cohort 2) |
49.1; 39.6 | — |
| PRIMARY PK: Cmax of LY3484356 (Cohort 3) |
30.3; 56.7 | — |
| PRIMARY PK: Cmax of LY3484356 (Cohort 4) |
49.6; 33.3 | — |
Summary
The main purpose of this study is to evaluate the amount of LY3484356 that is found in the blood stream and how long the body takes to get rid of it when given with and without food. Participants are healthy females of non-childbearing potential. The study will also evaluate the tolerability and safety of LY3484356 by collecting the information about any side effects that may occur. The participant's involvement with the study will last approximately 27 days, not including screening.
Eligibility Criteria
Inclusion Criteria
- Participants who are overtly healthy as determined by medical assessment
- Body mass index (BMI) within the range 18.0 to 35.0 kilograms per meter squared (kg/m²)
- Female participants of non childbearing potential. This includes females who are not pregnant, non-lactating and either: Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy or bilateral salpingectomy, bilateral tubal ligation, or bilateral tubal occlusion), or alternate medical cause/congenital anomaly (for example, Müllerian agenesis) or postmenopausal
Exclusion Criteria
- Have a history or presence of cardiovascular (eg, symptomatic bradycardia with resting heart rate of <60 beats per minute), respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- Show evidence of hepatitis B, evidence of hepatitis C and/or have evidence of human immunodeficiency virus (HIV) infection
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing
- Use or intend to use medications that inhibit or induce CYP3A4 within 14 days prior to dosing until completion of the follow-up visit
- Smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e cigarettes (nicotine and non nicotine) per day
Data sourced from ClinicalTrials.gov (NCT04840888). 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.