Healthy
Conditions
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
Administered orally.
Administered orally.
Administered orally.
Administered orally.
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline 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
| Measure | Time frame | Description |
|---|---|---|
| Part B: PK: Maximum Concentration (Cmax) of LY3154885 | 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. | Part B: PK: Maximum Concentration (Cmax) of LY3154885 |
| Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose | Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885 |
| Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885 |
| Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose | Part 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 LY3154885 | 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. | 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) LY3154885 | 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. | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Period 2 | Physician Decision | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Part 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 Itraconazole | Part B: Placebo + 200 mg Itraconazole |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 9 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 3 Participants | 1 Participants | 4 Participants | 3 Participants | 3 Participants | 4 Participants | 7 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 2 Participants | 1 Participants | 4 Participants | 2 Participants | 2 Participants | 4 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 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 | 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 2 Participants | 3 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 5 Participants | 2 Participants |
| Region of Enrollment United States | 36 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 9 Participants | 3 Participants |
| Sex: Female, Male Female | 9 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 27 Participants | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 1 Participants | 3 Participants | 9 Participants | 3 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 3 | 0 / 9 | 0 / 12 | 0 / 9 | 0 / 3 |
| other Total, other adverse events | 2 / 23 | 0 / 8 | 0 / 8 | 1 / 8 | 0 / 8 | 2 / 8 | 6 / 8 | 0 / 3 | 0 / 9 | 1 / 12 | 1 / 9 | 0 / 3 |
| serious Total, serious adverse events | 0 / 23 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 3 | 0 / 9 | 0 / 12 | 0 / 9 | 0 / 3 |
Outcome results
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A Placebo | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Part A 15 mg LY3154885 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Part A 45 mg LY3154885 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Part A 100 mg LY3154885 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Part A 200 mg LY3154885 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Part A 300 mg LY3154885 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Part A 375 mg LY3154885 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Part B: 45 LY3154885 + 200 mg Itraconazole | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| Part B: Placebo + 200 mg Itraconazole | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A Placebo | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885 | 95.7 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 35 |
| Part A 15 mg LY3154885 | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885 | 156 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 43 |
| Part A 45 mg LY3154885 | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885 | 519 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 39 |
| Part A 100 mg LY3154885 | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885 | 763 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 69 |
| Part A 200 mg LY3154885 | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885 | 1180 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 38 |
| Part A 300 mg LY3154885 | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885 | 1360 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 43 |
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A Placebo | Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885 | 1290 nanogram hour per milliliter (h*ng/mL) | Geometric Coefficient of Variation 53 |
| Part A 15 mg LY3154885 | Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885 | 2710 nanogram hour per milliliter (h*ng/mL) | Geometric Coefficient of Variation 48 |
| Part A 45 mg LY3154885 | Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885 | 8410 nanogram hour per milliliter (h*ng/mL) | Geometric Coefficient of Variation 59 |
| Part A 100 mg LY3154885 | Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885 | 14900 nanogram hour per milliliter (h*ng/mL) | Geometric Coefficient of Variation 96 |
| Part A 200 mg LY3154885 | Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885 | 30900 nanogram hour per milliliter (h*ng/mL) | Geometric Coefficient of Variation 82 |
| Part A 300 mg LY3154885 | Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885 | 28600 nanogram hour per milliliter (h*ng/mL) | Geometric Coefficient of Variation 48 |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A Placebo | Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885 | 3.00 Hours |
| Part A 15 mg LY3154885 | Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885 | 4.00 Hours |
| Part A 45 mg LY3154885 | Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885 | 3.01 Hours |
| Part A 100 mg LY3154885 | Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885 | 3.00 Hours |
| Part A 200 mg LY3154885 | Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885 | 3.00 Hours |
| Part A 300 mg LY3154885 | Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885 | 3.02 Hours |
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A Placebo | Part B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885 | LY3154885 Single Dose (Day 1) | 4510 h*ng/mL | Geometric Coefficient of Variation 54 |
| Part A Placebo | Part B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885 | LY3154885 Single Dose + Itraconazole QD (Day 14) | NA h*ng/mL | — |
| Part A 15 mg LY3154885 | Part B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885 | LY3154885 Single Dose (Day 1) | NA h*ng/mL | — |
| Part A 15 mg LY3154885 | Part B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885 | LY3154885 Single Dose + Itraconazole QD (Day 14) | 16900 h*ng/mL | Geometric Coefficient of Variation 34 |
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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A Placebo | Part B: PK: Maximum Concentration (Cmax) of LY3154885 | LY3154885 Single Dose (Day 1) | 219 ng/mL | Geometric Coefficient of Variation 52 |
| Part A Placebo | Part B: PK: Maximum Concentration (Cmax) of LY3154885 | LY3154885 Single Dose + Itraconazole QD (Day 14) | NA ng/mL | — |
| Part A 15 mg LY3154885 | Part B: PK: Maximum Concentration (Cmax) of LY3154885 | LY3154885 Single Dose (Day 1) | NA ng/mL | — |
| Part A 15 mg LY3154885 | Part B: PK: Maximum Concentration (Cmax) of LY3154885 | LY3154885 Single Dose + Itraconazole QD (Day 14) | 408 ng/mL | Geometric Coefficient of Variation 33 |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A Placebo | Part B, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885 | LY3154885 Single Dose (Day 1) | 2.00 Hours |
| Part A Placebo | Part B, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885 | LY3154885 Single Dose + Itraconazole QD (Day 14) | NA Hours |
| Part A 15 mg LY3154885 | Part B, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885 | LY3154885 Single Dose (Day 1) | NA Hours |
| Part A 15 mg LY3154885 | Part B, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885 | LY3154885 Single Dose + Itraconazole QD (Day 14) | 6.00 Hours |