A Study of LY3484356 in Healthy Female Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Omeprazole; Drug: Itraconazole; Drug: Carbamazepine; Drug: LY3484356

Study type: Interventional

Funder types: Industry

Identifiers

NCT04840888

18204

J2J-MC-JZLD (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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82 participants in 4 patient groups

LY3484356 (Cohort 1)

Experimental group

Description:

LY3484356 administered as single doses orally with (fed) or without food (fasted).

Treatment:

Drug: LY3484356

LY3484356 + Omeprazole (Cohort 2)

Experimental group

Description:

LY3484356 administered as single dose orally on Day 1 and omeprazole administered orally as single dose on Days 5 to 8 followed by a single dose of LY3484356 co-administered with a single dose of omeprazole on Day 9 orally.

Treatment:

Drug: Omeprazole

Drug: LY3484356

LY3484356 + Itraconazole (Cohort 3)

Experimental group

Description:

LY3484356 administered as single dose orally on Day 1 and itraconazole administered orally as single dose on Days 5 to 9. The single dose of LY3484356 co-administered with a single dose of itraconazole on Day 10 orally followed by single dose of itraconazole administered orally on Days 11 to 16.

Treatment:

Drug: Itraconazole

Drug: LY3484356

LY3484356 + Carbamazepine (Cohort 4)

Experimental group

Description:

LY3484356 administered as single dose orally on Day 1 and carbamazepine administered orally as single dose on Days 5 to 11. The single dose of LY3484356 co-administered with a single dose of carbamazepine on Day 12 orally followed by single dose of carbamazepine administered orally on Days 13 to 15.

Treatment:

Drug: LY3484356

Drug: Carbamazepine