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| ID | Type | Description | Link |
|---|---|---|---|
| J1Z-MC-HUAA | Other Identifier | Eli Lilly and Company |
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HUAA study is terminated early due to a business decision.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3154885 - Part A | Experimental | 15, 45, 100, 200, 300 or 375 milligrams (mg) LY3154885 administered orally in two of three study periods. |
|
| Placebo - Part A | Placebo Comparator | Placebo administered orally in one of three study periods. |
|
| 45 mg LY3154885 + Itraconazole - Part B | Experimental | 45 mg LY3154885 administered orally in period 1 followed by 200 mg Itraconazole administered orally on 10 consecutive days and then 45 mg LY3154885 co-administered with 200 mg itraconazole orally during period 2. |
|
| Placebo + Itraconazole - Part B | Placebo Comparator | Placebo administered orally during period 1 followed by 200 mg Itraconazole administered orally on 10 consecutive days and then placebo co-administered with 200 mg itraconazole orally during period 2. |
|
| LY3154885 - Part C | Experimental | Part C was not initiated. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3154885 - Capsule | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through Study Completion (Up to 5 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of 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 B: PK: Maximum Concentration (Cmax) of LY3154885 |
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Inclusion Criteria:
Are overtly healthy males or females, as determined by medical history and physical examination
Male participants:
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:
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);
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
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance | Dallas | Texas | 75247 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 milligrams (mg) LY3154885 administered orally on Day 1. Period 3: Participants received 375 mg LY3154885 administered orally on Day 1. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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 |
| FG006 | 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. |
| FG007 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Washout 1 (7 Days) |
| ||||||||||||||||
| Period 2 |
| ||||||||||||||||
| Washout 2 (7 Days) |
| ||||||||||||||||
| Period 3 |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through Study Completion (Up to 5 Months) |
|
Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A Placebo | Participants received Placebo administered orally. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
A strategic business decision was made to terminate the study prior to initiation of the multiple-ascending dose study (Part C). The secondary objectives pertaining to Part D were not evaluated as the study was terminated before the commencement of Part D.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2019 | Jun 22, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 18, 2019 | Jun 22, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo - Part C | Placebo Comparator | Part C was not initiated. |
|
| LY3154885 - Part D | Experimental | Part D was not initiated. |
|
| Placebo - Capsule | Drug | Administered orally. |
|
| Itraconazole | Drug | Administered orally. |
|
| LY3154885 - Tablet | Drug | Administered orally. |
|
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 A, PK: Time to Maximum Plasma Concentration (Tmax) 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 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. |
| 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 | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose |
| 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 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
|
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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 |
| BG006 | 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. |
| BG007 | 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 |
| BG008 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Participants received Placebo administered orally. |
| OG001 | Part A 15 mg LY3154885 | Participants received 15 mg LY3154885 administered orally. |
| OG002 | Part A 45 mg LY3154885 | Participants received 45 mg LY3154885 administered orally. |
| OG003 | Part A 100 mg LY3154885 | Participants received 100 mg LY3154885 administered orally. |
| OG004 | Part A 200 mg LY3154885 | Participants received 200 mg LY3154885 administered orally. |
| OG005 | Part A 300 mg LY3154885 | Participants received 300 mg LY3154885 administered orally. |
| OG006 | Part A 375 mg LY3154885 | Participants received 375 mg LY3154885 administered orally. |
| OG007 | 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. |
| OG008 | 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. |
|
|
| Secondary | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885 | Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885 | Part A: All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter (ng/mL) | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose |
|
|
|
| Secondary | Part B: PK: Maximum Concentration (Cmax) of LY3154885 | Part B: PK: Maximum Concentration (Cmax) of LY3154885 | Part B: All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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. |
|
|
|
| Secondary | Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885 | Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885 | Part A: All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Median | Full Range | Hours | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose |
|
|
|
| Secondary | Part B, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885 | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Median | Full Range | Hours | 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. |
|
|
|
| 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 | Part A: All participants who received at least one dose of study drug who had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram hour per milliliter (h*ng/mL) | Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dose |
|
|
|
| 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 | Part B: All participants who received at least one dose of study drug who had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 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. |
|
|
|
| 23 |
| 0 |
| 23 |
| 2 |
| 23 |
| EG001 | Part A 15 mg LY3154885 | Participants received 15 mg LY3154885 administered orally. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Part A 45 mg LY3154885 | Participants received 45 mg LY3154885 administered orally. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | Part A 100 mg LY3154885 | Participants received 100 mg LY3154885 administered orally. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG004 | Part A 200 mg LY3154885 | Participants received 200 mg LY3154885 administered orally. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG005 | Part A 300 mg LY3154885 | Participants received 300 mg LY3154885 administered orally. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG006 | Part A 375 mg LY3154885 | Participants received 375 mg LY3154885 administered orally. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG007 | Part B Placebo | Participants received Placebo administered orally. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG008 | Part B 45 mg LY3154885 | Participants received 45 mg LY3154885 administered orally. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG009 | Part B 200 mg Itraconazole | Participants received 200 mg Itraconazole administered orally. | 0 | 12 | 0 | 12 | 1 | 12 |
| EG010 | Part B 45 mg LY3154885 + 200 mg Itraconazole | Participants received 45 mg LY3154885 + 200 mg Itraconazole administered orally. | 0 | 9 | 0 | 9 | 1 | 9 |
| EG011 | Part B Placebo + 200 mg Itraconazole | Participants received Placebo + 200 mg Itraconazole administered orally. | 0 | 3 | 0 | 3 | 0 | 3 |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Energy increased | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Feeling jittery | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
Not provided
| D010879 |
| Piperazines |