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A Study of LY3154885 in Healthy Participants

Single- and Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3154885 in Healthy Subjects

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04014361
Enrollment
36
Registered
2019-07-10
Start date
2019-08-09
Completion date
2020-02-09
Last updated
2024-03-12

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 learn more about the safety and side effects of LY3154885 when given by mouth to healthy participants. The study will have up to four parts. Each participant will enroll in only one part. The study will last up to 70 days for each participant, including screening and follow-up.

Interventions

DRUGLY3154885 - Capsule

Administered orally.

Administered orally.

DRUGItraconazole

Administered orally.

DRUGLY3154885 - Tablet

Administered orally.

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Are overtly healthy males or females, as determined by medical history and physical examination * Male participants: * Men, regardless of their fertility status, with partners who are nonpregnant women of childbearing potential, must agree to either remain abstinent (if this is their preferred and usual lifestyle) or use condoms with spermicide as well as 1 additional highly effective (\<1% failure rate) method of contraception or effective method of contraception (such as diaphragms with spermicide) for 3 months following dosing * Men with pregnant partners should use condoms with spermicide during intercourse for the duration of the study or for 3 months following dosing, whichever is longer * Men who are in exclusively same-sex relationships (as their preferred and usual lifestyle) or with female partners of non-childbearing potential are not required to use contraception * Men should refrain from sperm donation for the duration of the study or for 3 months following the last dose of study drug, whichever is longer * Female participants of non-childbearing potential, including those who are: * Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, confirmed tubal ligation, or tubal occlusion) or congenital anomaly such as Müllerian agenesis; or * Postmenopausal, defined as 1 of the following: * A woman at least 50 years of age with an intact uterus, not on hormone replacement therapy, who has had either: * Cessation of menses for at least 1 year; or * At least 6 months of spontaneous amenorrhea with a follicle-stimulating hormone level ≥40 milli-international units per milliliter (mIU/mL) at screening * A woman at least 55 years of age, not on hormone replacement therapy, who has had at least 6 months of spontaneous amenorrhea; or * A woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy * Have a body mass index (BMI) of 18.0 to 35.0 kilograms per square meter (kg/m²), inclusive

Exclusion criteria

* Have a marked baseline prolongation of/corrected QT (QTc) interval (for example, repeated demonstration of a QTcB interval \>450 milliseconds \[msec\] for males or \>470 msec for females); * A history of additional risk factors for Torsades de Pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome); * The use of concomitant medications that prolong the QT/QTc interval * Have an abnormal blood pressure (BP) (taken after the participant has been in a supine position for at least 5 minutes) for the population, as determined by a systolic BP \>140 millimeters of mercury (mmHg) or a diastolic BP \>90 mmHg at screening or a preexisting history of hypertension. Up to 2 additional measurements may be taken after an appropriate resting interval at screening to confirm eligibility * Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (such as Cushing syndrome, hyperthyroidism, hyperaldosteronism), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product (IMP); or of interfering with the interpretation of data * Have a history of or current significant psychiatric disorders

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug AdministrationBaseline through Study Completion (Up to 5 Months)An SAE is any AE from this study that results in one of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Secondary

MeasureTime frameDescription
Part B: PK: Maximum Concentration (Cmax) of LY3154885Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post dose; Day 14: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 and 96 hours post dose.Part B: PK: Maximum Concentration (Cmax) of LY3154885
Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dosePart A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dosePart A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885
Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dosePart A, PK: Area Under the Concentration Versus Time Curve to Infinity \[AUC(0-∞)\] of LY3154885
Part B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post dose; Day 14: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 and 96 hours post dose.Part B, PK: Area Under the Concentration Versus Time Curve to Infinity \[AUC(0-∞)\] of LY3154885
Part B, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post dose; Day 14: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 and 96 hours post dose.

Countries

United States

Participant flow

Participants by arm

ArmCount
Part A: Cohort 1, Sequence 1 (Placebo, 100 mg LY3154885, 375 mg LY3154885)
Period 1: Participants received Placebo administered orally on Day 1. Period 2: Participants received 100 mg LY3154885 administered orally on Day 1. Period 3: Participants received 375 mg LY3154885 administered orally on Day 1.
4
Part A: Cohort 1, Sequence 2 (15 mg LY3154885, Placebo, 375 mg LY3154885)
Period 1: Participants received 15 mg LY3154885 administered orally on Day 1. Period 2: Participants received Placebo administered orally on Day 1 Period 3: Participants received 375 mg LY3154885 administered orally on Day 1.
4
Part A: Cohort 1, Sequence 3 (15 mg LY3154885, 100 mg LY3154885, Placebo)
Period 1: Participants received 15 mg LY3154885 administered orally on Day 1. Period 2: Participants received 100 mg LY3154885 administered orally on Day 1. Period 3: Participants received Placebo administered orally on Day 1.
4
Part A: Cohort 2, Sequence 1 (45 mg LY3154885, 200 mg LY3154885, Placebo)
Period 1: Participants received 45 mg LY3154885 administered orally on Day 1. Period 2: Participants received 200 mg LY3154885 administered orally on Day 1. Period 3: Participants received Placebo administered orally on Day 1.
4
Part A: Cohort 2, Sequence 2 (Placebo, 200 mg LY3154885, 300 mg LY3154885)
Period 1: Participants received Placebo administered orally on Day 1. Period 2: Participants received 200 mg LY3154885 administered orally on Day 1. Period 3: Participants received 300 mg LY3154885 administered orally on Day 1.
4
Part A: Cohort 2, Sequence 3 (45 mg LY3154885, Placebo, 300 mg LY3154885)
Period 1: Participants received 45 mg LY3154885 administered orally on Day 1. Period 2: Participants received Placebo administered orally on Day 1. Period 3: Participants received 300 mg LY3154885 administered orally on Day 1
4
Part B: 45 LY3154885 + 200 mg Itraconazole
Period 1: Participants received 45 mg LY3154885 administered orally. Period 2: Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then 45 mg LY3154885 co-administered with 200 mg itraconazole orally.
9
Part B: Placebo + 200 mg Itraconazole
Period 1: Participants received placebo administered orally. Period 2: Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then placebo co-administered with 200 mg itraconazole orally
3
Total36

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007
Period 2Physician Decision00010000

Baseline characteristics

CharacteristicTotalPart A: Cohort 1, Sequence 2 (15 mg LY3154885, Placebo, 375 mg LY3154885)Part A: Cohort 1, Sequence 3 (15 mg LY3154885, 100 mg LY3154885, Placebo)Part A: Cohort 2, Sequence 1 (45 mg LY3154885, 200 mg LY3154885, Placebo)Part A: Cohort 1, Sequence 1 (Placebo, 100 mg LY3154885, 375 mg LY3154885)Part A: Cohort 2, Sequence 2 (Placebo, 200 mg LY3154885, 300 mg LY3154885)Part A: Cohort 2, Sequence 3 (45 mg LY3154885, Placebo, 300 mg LY3154885)Part B: 45 LY3154885 + 200 mg ItraconazolePart B: Placebo + 200 mg Itraconazole
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
36 Participants4 Participants4 Participants4 Participants4 Participants4 Participants4 Participants9 Participants3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants1 Participants3 Participants0 Participants1 Participants1 Participants0 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
27 Participants3 Participants1 Participants4 Participants3 Participants3 Participants4 Participants7 Participants2 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
20 Participants2 Participants1 Participants4 Participants2 Participants2 Participants4 Participants4 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
16 Participants2 Participants3 Participants0 Participants2 Participants2 Participants0 Participants5 Participants2 Participants
Region of Enrollment
United States
36 Participants4 Participants4 Participants4 Participants4 Participants4 Participants4 Participants9 Participants3 Participants
Sex: Female, Male
Female
9 Participants1 Participants1 Participants2 Participants1 Participants3 Participants1 Participants0 Participants0 Participants
Sex: Female, Male
Male
27 Participants3 Participants3 Participants2 Participants3 Participants1 Participants3 Participants9 Participants3 Participants

Adverse events

Event typeEG000
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
deaths
Total, all-cause mortality
0 / 230 / 80 / 80 / 80 / 80 / 80 / 80 / 30 / 90 / 120 / 90 / 3
other
Total, other adverse events
2 / 230 / 80 / 81 / 80 / 82 / 86 / 80 / 30 / 91 / 121 / 90 / 3
serious
Total, serious adverse events
0 / 230 / 80 / 80 / 80 / 80 / 80 / 80 / 30 / 90 / 120 / 90 / 3

Outcome results

Primary

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

An SAE is any AE from this study that results in one of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Time frame: Baseline through Study Completion (Up to 5 Months)

Population: All participants who received at least one dose of study drug.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Part A PlaceboNumber of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration0 Participants
Part A 15 mg LY3154885Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration0 Participants
Part A 45 mg LY3154885Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration0 Participants
Part A 100 mg LY3154885Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration0 Participants
Part A 200 mg LY3154885Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration0 Participants
Part A 300 mg LY3154885Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration0 Participants
Part A 375 mg LY3154885Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration0 Participants
Part B: 45 LY3154885 + 200 mg ItraconazoleNumber of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration0 Participants
Part B: Placebo + 200 mg ItraconazoleNumber of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration0 Participants
Secondary

Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885

Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885

Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose

Population: Part A: All participants who received at least one dose of study drug and had evaluable PK data.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A PlaceboPart A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY315488595.7 Nanograms per milliliter (ng/mL)Geometric Coefficient of Variation 35
Part A 15 mg LY3154885Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885156 Nanograms per milliliter (ng/mL)Geometric Coefficient of Variation 43
Part A 45 mg LY3154885Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885519 Nanograms per milliliter (ng/mL)Geometric Coefficient of Variation 39
Part A 100 mg LY3154885Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885763 Nanograms per milliliter (ng/mL)Geometric Coefficient of Variation 69
Part A 200 mg LY3154885Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY31548851180 Nanograms per milliliter (ng/mL)Geometric Coefficient of Variation 38
Part A 300 mg LY3154885Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY31548851360 Nanograms per milliliter (ng/mL)Geometric Coefficient of Variation 43
Secondary

Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885

Part A, PK: Area Under the Concentration Versus Time Curve to Infinity \[AUC(0-∞)\] of LY3154885

Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose

Population: Part A: All participants who received at least one dose of study drug who had evaluable PK data.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Part A PlaceboPart A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY31548851290 nanogram hour per milliliter (h*ng/mL)Geometric Coefficient of Variation 53
Part A 15 mg LY3154885Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY31548852710 nanogram hour per milliliter (h*ng/mL)Geometric Coefficient of Variation 48
Part A 45 mg LY3154885Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY31548858410 nanogram hour per milliliter (h*ng/mL)Geometric Coefficient of Variation 59
Part A 100 mg LY3154885Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY315488514900 nanogram hour per milliliter (h*ng/mL)Geometric Coefficient of Variation 96
Part A 200 mg LY3154885Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY315488530900 nanogram hour per milliliter (h*ng/mL)Geometric Coefficient of Variation 82
Part A 300 mg LY3154885Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY315488528600 nanogram hour per milliliter (h*ng/mL)Geometric Coefficient of Variation 48
Secondary

Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885

Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885

Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose

Population: Part A: All participants who received at least one dose of study drug and had evaluable PK data.

ArmMeasureValue (MEDIAN)
Part A PlaceboPart A, PK: Time to Maximum Plasma Concentration (Tmax) LY31548853.00 Hours
Part A 15 mg LY3154885Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY31548854.00 Hours
Part A 45 mg LY3154885Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY31548853.01 Hours
Part A 100 mg LY3154885Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY31548853.00 Hours
Part A 200 mg LY3154885Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY31548853.00 Hours
Part A 300 mg LY3154885Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY31548853.02 Hours
Secondary

Part B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885

Part B, PK: Area Under the Concentration Versus Time Curve to Infinity \[AUC(0-∞)\] of LY3154885

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post dose; Day 14: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 and 96 hours post dose.

Population: Part B: All participants who received at least one dose of study drug who had evaluable PK data.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part A PlaceboPart B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885LY3154885 Single Dose (Day 1)4510 h*ng/mLGeometric Coefficient of Variation 54
Part A PlaceboPart B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885LY3154885 Single Dose + Itraconazole QD (Day 14)NA h*ng/mL
Part A 15 mg LY3154885Part B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885LY3154885 Single Dose (Day 1)NA h*ng/mL
Part A 15 mg LY3154885Part B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885LY3154885 Single Dose + Itraconazole QD (Day 14)16900 h*ng/mLGeometric Coefficient of Variation 34
Secondary

Part B: PK: Maximum Concentration (Cmax) of LY3154885

Part B: PK: Maximum Concentration (Cmax) of LY3154885

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post dose; Day 14: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 and 96 hours post dose.

Population: Part B: All participants who received at least one dose of study drug and had evaluable PK data.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Part A PlaceboPart B: PK: Maximum Concentration (Cmax) of LY3154885LY3154885 Single Dose (Day 1)219 ng/mLGeometric Coefficient of Variation 52
Part A PlaceboPart B: PK: Maximum Concentration (Cmax) of LY3154885LY3154885 Single Dose + Itraconazole QD (Day 14)NA ng/mL
Part A 15 mg LY3154885Part B: PK: Maximum Concentration (Cmax) of LY3154885LY3154885 Single Dose (Day 1)NA ng/mL
Part A 15 mg LY3154885Part B: PK: Maximum Concentration (Cmax) of LY3154885LY3154885 Single Dose + Itraconazole QD (Day 14)408 ng/mLGeometric Coefficient of Variation 33
Secondary

Part B, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post dose; Day 14: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 and 96 hours post dose.

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

ArmMeasureGroupValue (MEDIAN)
Part A PlaceboPart B, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885LY3154885 Single Dose (Day 1)2.00 Hours
Part A PlaceboPart B, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885LY3154885 Single Dose + Itraconazole QD (Day 14)NA Hours
Part A 15 mg LY3154885Part B, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885LY3154885 Single Dose (Day 1)NA Hours
Part A 15 mg LY3154885Part B, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885LY3154885 Single Dose + Itraconazole QD (Day 14)6.00 Hours

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026