A Study of LY3484356 in Healthy Female Participants

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04840888

Enrollment

Registered

2021-04-12

Start date

2021-04-26

Completion date

2022-04-12

Last updated

2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGLY3484356

Administered orally.

DRUGOmeprazole

Administered orally.

DRUGItraconazole

Administered orally.

DRUGCarbamazepine

Administered orally.

DRUGMidazolam

Administered orally.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
PK: AUC[0-∞] of LY3484356 (Cohort 3)	Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose	PK: AUC\[0-∞\] of LY3484356
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 (Cohort 1)	Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours (h) postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose	PK: AUC\[0-∞\] of LY3484356
PK: AUC[0-∞] of LY3484356 (Cohort 2)	Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose	PK: AUC\[0-∞\] of LY3484356
PK: AUC[0-∞] of LY3484356 (Cohort 4)	Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose	AUC\[0-∞\] of LY3484356
PK: Time of Maximum Observed Concentration (Tmax) of LY3484356 (Cohort 1)	Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose	PK: Tmax of LY3484356
PK: Tmax of LY3484356 (Cohort 2)	Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose	PK: Tmax of LY3484356
PK: Tmax of LY3484356 (Cohort 3)	Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose	PK: Tmax of LY3484356
PK: Tmax of LY3484356 (Cohort 4)	Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose	Tmax of LY3484356
PK: Maximum Observed Concentration (Cmax) of LY3484356 (Cohort 1)	Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose	Cmax of LY3484356
PK: Cmax of LY3484356 (Cohort 2)	Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose	Cmax of LY3484356
PK: Cmax of LY3484356 (Cohort 3)	Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose	Cmax of LY3484356
PK: Cmax of LY3484356 (Cohort 4)	Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose	Cmax of LY3484356

Countries

United States

Participant flow

Participants by arm

Arm	Count
Cohort 1: Sequence 1/Sequence 2 Participants were randomized (1:1) to 1 of 2 treatment sequences; LY3484356 received as single dose with (fed) or without food (fasted) administered orally as below: Cohort 1 Sequence 1: Period 1: Single dose of 400 mg LY3484356 in the fed state. Period 2: Single dose of 400 mg LY3484356 in the fasted state. Cohort 1 Sequence 2: Period 1: Single dose of 400 mg LY3484356 in the fasted state. Period 2: Single dose of 400 mg LY3484356 in the fed state. There was a washout period of 4 days between doses of LY3484356	8
Cohort 2: LY3484356 + Omeprazole Participants received single dose of LY3484356 and a single dose of omeprazole alone and in combination administered orally as below: Day 1: 400 mg LY3484356 alone Days 5 to 8: 40 mg omeprazole alone once daily Day 9: 400 mg LY3484356 + 40 mg omeprazole once There was a washout period of 8 days between doses of LY3484356.	10
Cohort 3: LY3484356 + Itraconazole Participants received single dose of LY3484356 and a single dose of Itraconazole alone and in combination administered orally as below: Day 1: 200 mg LY3484356 alone Days 5 to 9: 200 mg itraconazole alone (twice on Day 5 \[dose separated by approximately 12 hours\], then once daily on Days 6 through 9) Day 10: 200 mg LY3484356 + 200 mg itraconazole once (coadministered with the morning dose) Days 11 to 16: 200 mg itraconazole alone once daily. There was a washout period of 9 days between doses of LY3484356	20
Cohort 4: LY3484356 + Carbamazepine Participants received single dose of LY3484356 and a single dose of carbamazepine alone and in combination administered orally as below: Day 1: 400 mg LY3484356 alone Days 6 to 8: 100 mg carbamazepine BID alone Days 9 to 11: 200 mg carbamazepine BID alone Days 12 to 17: 300 mg carbamazepine BID alone Day 18: 300 mg carbamazepine BID + 400 mg LY3484356 (coadministered with morning dose) Days 19 to 22: 300 mg carbamazepine BID alone Day 23: 300 mg carbamazepine alone (morning dose only). There was a washout period of 17 days between doses of LY3484356.	29
Cohort 5: Carbamazepine + Midazolam Participants received single dose of Carbamazepine and a single dose of midazolam alone and in combination administered orally as below: Day 1: 1.2 mg midazolam alone Days 2 to 4: 100 mg carbamazepine BID alone Days 5 to 7: 200 mg carbamazepine BID alone Days 8 to 10: 300 mg carbamazepine BID alone Day 11: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose) Days 12 to 13: 300 mg carbamazepine BID alone Day 14: 300 mg carbamazepine BID + 1.2 mg midazolam (coadministered with morning dose)	15
Total	82

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Period 1	Adverse Event	0	0	1	1	10	1
Period 1	Withdrawal by Subject	0	0	0	0	1	0

Baseline characteristics

Characteristic	Cohort 1: Sequence 1/Sequence 2	Total	Cohort 5: Carbamazepine + Midazolam	Cohort 4: LY3484356 + Carbamazepine	Cohort 3: LY3484356 + Itraconazole	Cohort 2: LY3484356 + Omeprazole
Age, Continuous	51.8 years STANDARD_DEVIATION 6.9	51.1 years STANDARD_DEVIATION 9.8	46.4 years STANDARD_DEVIATION 10.4	49.8 years STANDARD_DEVIATION 10.1	52.5 years STANDARD_DEVIATION 9.2	58.6 years STANDARD_DEVIATION 6.9
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	45 Participants	8 Participants	18 Participants	11 Participants	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants	37 Participants	7 Participants	11 Participants	9 Participants	5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	3 Participants	18 Participants	2 Participants	8 Participants	2 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	4 Participants	63 Participants	13 Participants	21 Participants	18 Participants	7 Participants
Region of Enrollment United States	8 Participants	82 Participants	15 Participants	29 Participants	20 Participants	10 Participants
Sex: Female, Male Female	8 Participants	70 Participants	3 Participants	29 Participants	20 Participants	10 Participants
Sex: Female, Male Male	0 Participants	12 Participants	12 Participants	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk	EG011 affected / at risk	EG012 affected / at risk	EG013 affected / at risk	EG014 affected / at risk	EG015 affected / at risk	EG016 affected / at risk	EG017 affected / at risk	EG018 affected / at risk	EG019 affected / at risk
deaths Total, all-cause mortality	0 / 8	0 / 8	0 / 10	0 / 10	0 / 9	0 / 20	0 / 20	0 / 20	0 / 29	0 / 28	0 / 28	0 / 28	0 / 20	0 / 15	0 / 15	0 / 15	0 / 15	0 / 15	0 / 15	0 / 14
other Total, other adverse events	1 / 8	1 / 8	2 / 10	2 / 10	1 / 9	5 / 20	8 / 20	2 / 20	2 / 29	1 / 28	6 / 28	16 / 28	3 / 20	0 / 15	1 / 15	0 / 15	2 / 15	1 / 15	2 / 15	0 / 14
serious Total, serious adverse events	0 / 8	0 / 8	0 / 10	0 / 10	0 / 9	0 / 20	0 / 20	0 / 20	0 / 29	0 / 28	0 / 28	1 / 28	0 / 20	0 / 15	0 / 15	0 / 15	0 / 15	0 / 15	0 / 15	0 / 14

Outcome results

Primary

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 (Cohort 1)

PK: AUC\[0-∞\] of LY3484356

Time frame: Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours (h) postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose

Population: All enrolled participants in cohort 1 who received at least one dose of study drug and had evaluable PK data.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Cohort 1: 400 mg LY3484356 Fasted	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 (Cohort 1)	1810 nanogramhour per milliliter (nghr/mL)	Geometric Coefficient of Variation 59
Cohort 1: 400 mg LY3484356 Fed	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 (Cohort 1)	4350 nanogramhour per milliliter (nghr/mL)	Geometric Coefficient of Variation 39

Primary

PK: AUC[0-∞] of LY3484356 (Cohort 2)

PK: AUC\[0-∞\] of LY3484356

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose

Population: All enrolled participants in cohort 2 who received at least one dose of study drug and had evaluable PK data.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Cohort 1: 400 mg LY3484356 Fasted	PK: AUC[0-∞] of LY3484356 (Cohort 2)	Day 1	2270 ng*hr/mL	Geometric Coefficient of Variation 93
Cohort 1: 400 mg LY3484356 Fasted	PK: AUC[0-∞] of LY3484356 (Cohort 2)	Day 9	1960 ng*hr/mL	Geometric Coefficient of Variation 46

Primary

PK: AUC[0-∞] of LY3484356 (Cohort 3)

PK: AUC\[0-∞\] of LY3484356

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose

Population: All enrolled participants in cohort 3 who received at least one dose of study drug and had evaluable PK data.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Cohort 1: 400 mg LY3484356 Fasted	PK: AUC[0-∞] of LY3484356 (Cohort 3)	Day 1	1430 ng*hr/mL	Geometric Coefficient of Variation 58
Cohort 1: 400 mg LY3484356 Fasted	PK: AUC[0-∞] of LY3484356 (Cohort 3)	Day 10	3120 ng*hr/mL	Geometric Coefficient of Variation 41

Primary

PK: AUC[0-∞] of LY3484356 (Cohort 4)

AUC\[0-∞\] of LY3484356

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose

Population: All enrolled participants in cohort 4 who received at least one dose of study drug and had evaluable PK data.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Cohort 1: 400 mg LY3484356 Fasted	PK: AUC[0-∞] of LY3484356 (Cohort 4)	Day 1	1950 ng*hr/mL	Geometric Coefficient of Variation 67
Cohort 1: 400 mg LY3484356 Fasted	PK: AUC[0-∞] of LY3484356 (Cohort 4)	Day 18	1090 ng*hr/mL	Geometric Coefficient of Variation 32

Primary

PK: Cmax of LY3484356 (Cohort 2)

Cmax of LY3484356

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose

Population: All enrolled participants in cohort 2 who received at least one dose of study drug and had evaluable PK data.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Cohort 1: 400 mg LY3484356 Fasted	PK: Cmax of LY3484356 (Cohort 2)	Day 1	49.1 ng/mL	Geometric Coefficient of Variation 61
Cohort 1: 400 mg LY3484356 Fasted	PK: Cmax of LY3484356 (Cohort 2)	Day 9	39.6 ng/mL	Geometric Coefficient of Variation 47

Primary

PK: Cmax of LY3484356 (Cohort 3)

Cmax of LY3484356

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose

Population: All enrolled participants in cohort 3 who received at least one dose of study drug and had evaluable PK data.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Cohort 1: 400 mg LY3484356 Fasted	PK: Cmax of LY3484356 (Cohort 3)	Day 1	30.3 ng/mL	Geometric Coefficient of Variation 57
Cohort 1: 400 mg LY3484356 Fasted	PK: Cmax of LY3484356 (Cohort 3)	Day 10	56.7 ng/mL	Geometric Coefficient of Variation 47

Primary

PK: Cmax of LY3484356 (Cohort 4)

Cmax of LY3484356

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose

Population: All enrolled participants in cohort 4 who received at least one dose of study drug and had evaluable PK data.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Cohort 1: 400 mg LY3484356 Fasted	PK: Cmax of LY3484356 (Cohort 4)	Day 1	49.6 ng/mL	Geometric Coefficient of Variation 76
Cohort 1: 400 mg LY3484356 Fasted	PK: Cmax of LY3484356 (Cohort 4)	Day 18	33.3 ng/mL	Geometric Coefficient of Variation 41

Primary

PK: Maximum Observed Concentration (Cmax) of LY3484356 (Cohort 1)

Cmax of LY3484356

Time frame: Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose

Population: All enrolled participants in cohort 1 who received at least one dose of study drug and had evaluable PK data.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Cohort 1: 400 mg LY3484356 Fasted	PK: Maximum Observed Concentration (Cmax) of LY3484356 (Cohort 1)	37.2 nanogram per millilitre (ng/mL)	Geometric Coefficient of Variation 51
Cohort 1: 400 mg LY3484356 Fed	PK: Maximum Observed Concentration (Cmax) of LY3484356 (Cohort 1)	143 nanogram per millilitre (ng/mL)	Geometric Coefficient of Variation 28

Primary

PK: Time of Maximum Observed Concentration (Tmax) of LY3484356 (Cohort 1)

PK: Tmax of LY3484356

Time frame: Period 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 h postdose; Period 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 and 96 h postdose

Population: All enrolled participants in cohort 1 who received at least one dose of study drug and had evaluable PK data.

Arm	Measure	Value (MEDIAN)
Cohort 1: 400 mg LY3484356 Fasted	PK: Time of Maximum Observed Concentration (Tmax) of LY3484356 (Cohort 1)	8.00 hours
Cohort 1: 400 mg LY3484356 Fed	PK: Time of Maximum Observed Concentration (Tmax) of LY3484356 (Cohort 1)	3.02 hours

Primary

PK: Tmax of LY3484356 (Cohort 2)

PK: Tmax of LY3484356

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 9: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose

Population: All enrolled participants in cohort 2 who received at least one dose of study drug and had evaluable PK data.

Arm	Measure	Group	Value (MEDIAN)
Cohort 1: 400 mg LY3484356 Fasted	PK: Tmax of LY3484356 (Cohort 2)	Day 1	6.02 hours
Cohort 1: 400 mg LY3484356 Fasted	PK: Tmax of LY3484356 (Cohort 2)	Day 9	6.00 hours

Primary

PK: Tmax of LY3484356 (Cohort 3)

PK: Tmax of LY3484356

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 10: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose

Population: All enrolled participants in cohort 3 who received at least one dose of study drug and had evaluable PK data.

Arm	Measure	Group	Value (MEDIAN)
Cohort 1: 400 mg LY3484356 Fasted	PK: Tmax of LY3484356 (Cohort 3)	Day 1	6.00 hours
Cohort 1: 400 mg LY3484356 Fasted	PK: Tmax of LY3484356 (Cohort 3)	Day 10	6.00 hours

Primary

PK: Tmax of LY3484356 (Cohort 4)

Tmax of LY3484356

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose; Day 18: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 h postdose

Population: All enrolled participants in cohort 4 who received at least one dose of study drug and had evaluable PK data.

Arm	Measure	Group	Value (MEDIAN)
Cohort 1: 400 mg LY3484356 Fasted	PK: Tmax of LY3484356 (Cohort 4)	Day 1	4.00 hours
Cohort 1: 400 mg LY3484356 Fasted	PK: Tmax of LY3484356 (Cohort 4)	Day 18	3.87 hours

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026

A Study of LY3484356 in Healthy Female Participants

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3484356 (Cohort 1)

PK: AUC[0-∞] of LY3484356 (Cohort 2)

PK: AUC[0-∞] of LY3484356 (Cohort 3)

PK: AUC[0-∞] of LY3484356 (Cohort 4)

PK: Cmax of LY3484356 (Cohort 2)

PK: Cmax of LY3484356 (Cohort 3)

PK: Cmax of LY3484356 (Cohort 4)

PK: Maximum Observed Concentration (Cmax) of LY3484356 (Cohort 1)

PK: Time of Maximum Observed Concentration (Tmax) of LY3484356 (Cohort 1)

PK: Tmax of LY3484356 (Cohort 2)

PK: Tmax of LY3484356 (Cohort 3)

PK: Tmax of LY3484356 (Cohort 4)