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| ID | Type | Description | Link |
|---|---|---|---|
| I9F-MC-SCAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to investigate the safety of LY3323795 and the effects it has on the body. The study drug or placebo (sugar pill) will be given by mouth to healthy participants. The study has three parts. Each participant may only enroll in one part. The study will last 14 to 43 days, depending on the part. Screening must be completed prior to study start.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3323795 (Part A) | Experimental | Participants received escalating doses of 0.3 mg (milligrams), 1 mg, 3 mg, 10 mg, 30 mg and 100 mg of LY3323795 orally. |
|
| Placebo (Part A) | Placebo Comparator | Participants received placebo identical to LY3323795 orally. |
|
| LY3323795 (Part B) | Experimental | Participants received 6 mg, 20 mg and 80 mg of LY3323795 orally. |
|
| Placebo (Part B) | Placebo Comparator | Participants received placebo identical to LY3323795 orally. |
|
| LY3323795 (Part C) | Experimental | Part C was not initiated due to a Lilly internal strategy decision. |
|
| LY3323795 + Itraconazole (Part C) | Experimental | Part C was not initiated due to a Lilly internal strategy decision. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3323795 | 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 | Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 19.1. A summary of non-serious adverse events and all serious adverse events, regardless of causality is located in the Reported Adverse Events section. | Baseline to Study Completion (up to Day 43) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Plasma | Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in plasma. | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dose |
| Part B Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Cerebrospinal Fluid (CSF) |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group | Glendale | California | 91260 | United States |
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Part A was a dose-escalation 3-period crossover with 2 alternating cohorts (Cohorts 1 and 2). There was 14 days of washout time between each dose. Part B was a single-dose, 3-cohort (Cohorts 3, 4 and 5) study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A-Cohort 1 (Sequence 1) | Participants received 0.3 milligrams (mg), 3 mg, 30 mg LY3323795 and Placebo. Period 1: Placebo, Period 2: 3 mg LY3323795, Period 3: 30 mg LY3323795 |
| FG001 | Part A-Cohort 1 (Sequence 2) | Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: Placebo, Period 3: 30 mg LY3323795 |
| FG002 | Part A-Cohort 1 (Sequence 3) | Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: 3 mg LY3323795, Period 3: Placebo |
| FG003 | Part A-Cohort 2 (Sequence 1) | Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: 10 mg LY3323795, Period 3: Placebo |
| FG004 | Part A-Cohort 2 (Sequence 2) | Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: Placebo, Period 2: 10 mg LY3323795, Period 3: 100 mg LY3323795 |
| FG005 | Part A-Cohort 2 (Sequence 3) | Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: Placebo, Period 3: 100 mg LY3323795 |
| FG006 | Part B, 6 mg LY3323795 | Participants received 6 mg of LY3323795 orally. |
| FG007 | Part B, 20 mg LY3323795 | Participants received 20 mg of LY3323795 orally. |
| FG008 | Part B, 80 mg LY3323795 | Participants received 80 mg of LY3323795 orally. |
| FG009 | Part B, Placebo | Participants received placebo identical to LY3323795 orally. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| |||||||||||||||||||||
| Period 2 |
| ||||||||||||||||||||||
| Period 3 |
|
All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A-Cohort 1 (Sequence 1) | Participants received 0.3 milligrams (mg), 3 mg, 30 mg LY3323795 and Placebo. Period 1: Placebo, Period 2: 3 mg LY3323795, Period 3: 30 mg LY3323795. |
| BG001 | Part A-Cohort 1 (Sequence 2) |
| 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 | Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 19.1. A summary of non-serious adverse events and all serious adverse events, regardless of causality is located in the Reported Adverse Events section. | All randomized participants who received study drug. | Posted | Count of Participants | Participants | No | Baseline to Study Completion (up to Day 43) |
|
Up to 43 days
All enrolled participants who received 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, Cohort 1, Placebo | Participants received placebo identical to LY3323795 orally. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 19.1 | Systematic Assessment |
Part C (an itraconazole interaction study) was not initiated due to a Lilly internal strategy decision.
| 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 | Dec 2, 2016 | Nov 12, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2016 | Nov 12, 2018 | 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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|
| Itraconazole | Drug | Administered orally |
|
| Placebo | Drug | Administered orally |
|
Part B Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in cerebrospinal fluid (CSF). |
| -4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dose |
| Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Plasma | Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC[0-tlast]) of LY3323795 in plasma. | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dose |
| Part B Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Cerebrospinal Fluid (CSF) | Part B Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC[0-tlast]) of LY3323795 in cerebrospinal fluid (CSF). | -4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dose |
| Pharmacodynamics (PD): Change From Baseline in Plasma Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂ | Amyloid beta is a peptide fragment of the amyloid precursor protein, plasma concentrations of Aβ1-40 and Aβ1-42 were determined using validated immunoassay methods. | Baseline through 144 hours |
| Part B Pharmacodynamics (PD): Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂ | Amyloid beta is a peptide fragment of the amyloid precursor protein, CSF concentrations of Aβ1-40, Aβ1-42 were determined using validated immunoassay methods. | Baseline through 36 hours |
| Physician Decision |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: Placebo, Period 3: 30 mg LY3323795.
| BG002 | Part A-Cohort 1 (Sequence 3) | Participants received 0.3 mg, 3 mg, 30 mg LY3323795 and Placebo. Period 1: 0.3 mg LY3323795, Period 2: 3 mg LY3323795, Period 3: Placebo. |
| BG003 | Part A-Cohort 2 (Sequence 1) | Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: 10 mg LY3323795, Period 3: Placebo. |
| BG004 | Part A-Cohort 2 (Sequence 2) | Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: Placebo, Period 2: 10 mg LY3323795, Period 3: 100 mg LY3323795. |
| BG005 | Part A-Cohort 2 (Sequence 3) | Participants received 1 mg, 10 mg, 100 mg of LY3323795 and Placebo. Period 1: 1 mg LY3323795, Period 2: Placebo, Period 3: 100 mg LY3323795. |
| BG006 | Part B, 6 mg LY3323795 | Participants received 6 mg of LY3323795 orally. |
| BG007 | Part B, 20 mg LY3323795 | Participants received 20 mg of LY3323795 orally. |
| BG008 | Part B, 80 mg LY3323795 | Participants received 80 mg of LY3323795 orally. |
| BG009 | Part B, Placebo | Participants received placebo identical to LY3323795 orally. |
| BG010 | 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 |
|
| OG001 |
| Part A, Cohort 1, 0.3 mg LY3323795 |
Participants received 0.3 mg of LY3323795 orally. |
| OG002 | Part A, Cohort 1, 3 mg LY3323795 | Participants received 3 mg of LY3323795 orally. |
| OG003 | Part A, Cohort 1, 30 mg LY3323795 | Participants received 30 mg of LY3323795 orally. |
| OG004 | Part A, Cohort 2, Placebo | Participants received placebo identical to LY3323795 orally. |
| OG005 | Part A, Cohort 2, 1 mg LY3323795 | Participants received 1 mg of LY3323795 orally. |
| OG006 | Part A, Cohort 2, 10 mg LY3323795 | Participants received 10 mg of LY3323795 orally. |
| OG007 | Part A, Cohort 2, 100 mg LY3323795 | Participants received 100 mg of LY3323795 orally. |
| OG008 | Part B, Placebo | Participants received placebo identical to LY3323795 orally. |
| OG009 | Part B, 6 mg LY3323795 | Participants received 6 mg of LY3323795 orally. |
| OG010 | Part B, 20 mg LY3323795 | Participants received 20 mg of LY3323795 orally. |
| OG011 | Part B, 80 mg LY3323795 | Participants received 80 mg of LY3323795 orally. |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Plasma | Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in plasma. | All randomized participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dose |
|
|
|
| Secondary | Part B Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Cerebrospinal Fluid (CSF) | Part B Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in cerebrospinal fluid (CSF). | All randomized participants from Part B group, who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | -4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dose |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Plasma | Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC[0-tlast]) of LY3323795 in plasma. | All randomized participants who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*h/mL) | 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dose |
|
|
|
| Secondary | Part B Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Cerebrospinal Fluid (CSF) | Part B Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC[0-tlast]) of LY3323795 in cerebrospinal fluid (CSF). | All randomized participants from Part B group, who received at least 1 dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dose |
|
|
|
| Secondary | Pharmacodynamics (PD): Change From Baseline in Plasma Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂ | Amyloid beta is a peptide fragment of the amyloid precursor protein, plasma concentrations of Aβ1-40 and Aβ1-42 were determined using validated immunoassay methods. | All randomized participants who received at least 1 dose of study drug and have baseline and at least one post-baseline plasma Aβ1-40 or Aβ1-42 data. | Posted | Mean | Standard Deviation | Picogram per milliliter (pg/mL) | Baseline through 144 hours |
|
|
|
| Secondary | Part B Pharmacodynamics (PD): Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)₁-₄₀ and Aβ₁-₄₂ | Amyloid beta is a peptide fragment of the amyloid precursor protein, CSF concentrations of Aβ1-40, Aβ1-42 were determined using validated immunoassay methods. | All randomized participants from Part B group, who received at least 1 dose of study drug and have baseline and at least one post-baseline CSF Aβ1-40 or Aβ1-42 data. | Posted | Mean | Standard Deviation | Picogram per milliliter (pg/mL) | Baseline through 36 hours |
|
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Part A, Cohort 1, 0.3 mg LY3323795 | Participants received 0.3 mg of LY3323795 orally. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | Part A, Cohort 1, 3 mg LY3323795 | Participants received 3 mg of LY3323795 orally. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Part A, Cohort 1, 30 mg LY3323795 | Participants received 30 mg of LY3323795 orally. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG004 | Part A, Cohort 2, Placebo | Participants received placebo identical to LY3323795 orally. | 0 | 9 | 0 | 9 | 1 | 9 |
| EG005 | Part A, Cohort 2, 1 mg LY3323795 | Participants received 1 mg of LY3323795 orally. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG006 | Part A, Cohort 2, 10 mg LY3323795 | Participants received 10 mg of LY3323795 orally. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG007 | Part A, Cohort 2, 100 mg LY3323795 | Participants received 100 mg of LY3323795 orally. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG008 | Part B, 6 mg LY3323795 | Participants received 6 mg of LY3323795 orally. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG009 | Part B, 20 mg LY3323795 | Participants received 20 mg of LY3323795 orally. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG010 | Part B, 80 mg LY3323795 | Participants received 80 mg of LY3323795 orally. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG011 | Part B, Placebo | Participants received placebo identical to LY3323795 orally. | 0 | 6 | 0 | 6 | 3 | 6 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
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| D010879 |
| Piperazines |
| Aβ1-42 |
|
| Aβ 1-42 |
|
| <0.001 |
| Mean Difference (Final Values) |
| -60.53 |
| 2-Sided |
| 90 |
| -69.79 |
| -48.43 |
| Superiority |
| Aβ 1-40 | Mixed Models Analysis | <0.001 | Mean Difference (Final Values) | -87.07 | 2-Sided | 90 | -90.21 | -82.92 | Superiority |
| Aβ 1-42 | Mixed Models Analysis | 0.015 | Mean Difference (Final Values) | -19.60 | 2-Sided | 90 | -33.69 | -2.51 | Superiority |
| Aβ 1-42 | Mixed Models Analysis | <0.001 | Mean Difference (Final Values) | -65.41 | 2-Sided | 90 | -72.23 | -56.92 | Superiority |
| Aβ 1-42 | Mixed Models Analysis | <0.001 | Mean Difference (Final Values) | -84.56 | 2-Sided | 90 | -88.97 | -78.38 | Superiority |