A Study of LY3484356 in Healthy Female Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT04840888

Collaborator

(none)

Enrollment

Locations

Arms

11.5

Actual Duration (Months)

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3484356 Drug: Omeprazole Drug: Itraconazole Drug: Carbamazepine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Evaluation of the Effect of Food, Omeprazole, Itraconazole, and Carbamazepine on the Pharmacokinetics of LY3484356 in Healthy Females of Non-Child-Bearing Potential

Actual Study Start Date :

Apr 26, 2021

Actual Primary Completion Date :

Apr 12, 2022

Actual Study Completion Date :

Apr 12, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3484356 (Cohort 1) LY3484356 administered as single doses orally with (fed) or without food (fasted).	Drug: LY3484356 Administered orally.
Experimental: LY3484356 + Omeprazole (Cohort 2) 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.	Drug: LY3484356 Administered orally. Drug: Omeprazole Administered orally.
Experimental: LY3484356 + Itraconazole (Cohort 3) 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.	Drug: LY3484356 Administered orally. Drug: Itraconazole Administered orally.
Experimental: LY3484356 + Carbamazepine (Cohort 4) 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.	Drug: LY3484356 Administered orally. Drug: Carbamazepine Administered orally.

Outcome Measures

Primary Outcome Measures

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 [Predose up to 168 hours postdose]
PK: AUC[0-∞] of LY3484356
PK: Maximum Observed Concentration (Cmax) of LY3484356 [Predose up to 168 hours postdose]
PK: Cmax of LY3484356
PK: Time of Maximum Observed Concentration (Tmax) of LY3484356 [Predose up to 168 hours postdose]
PK: Tmax of LY3484356

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LabCorp CRU, Inc.	Daytona Beach	Florida	United States	32117
2	Covance Dallas	Dallas	Texas	United States	75247

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:

NCT04840888

Other Study ID Numbers:

18204
J2J-MC-JZLD

First Posted:

Apr 12, 2021

Last Update Posted:

May 2, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Itraconazole

Carbamazepine

Omeprazole

Study Results

No Results Posted as of May 2, 2022