Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I4O-EW-BACX | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is being done for the following reasons:
To determine the safety of LY2886721 and any side effects that may be associated with it and to see how much of the study drug is in the blood and the cerebrospinal fluid (CSF) when one dose is given to healthy participants and participants diagnosed with Alzheimer's disease. It will also look at how safe and tolerable the study drug is when given to healthy participants in higher doses.
This research study is being conducted in three groups, referred to as Groups (Cohorts) A, B, or C.
Group A will enroll participants with Alzheimer's disease while Groups B and C will enroll healthy participants.
For Group A or B, participation in this research study could last up to 34 days. For Group C, participation could last up to 60 days.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: 70 mg LY2886721 | Experimental | Participants with Alzheimer's disease received a single, 70-milligrams (mg) (1 capsule), oral dose of LY2886721. |
|
| Cohort A: Placebo | Placebo Comparator | Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule). |
|
| Cohort B: 70 mg LY2886721 | Experimental | Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721. |
|
| Cohort B: Placebo | Placebo Comparator | Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule). |
|
| Cohort C: 280 mg LY2886721 | Experimental | Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721. |
|
| Cohort C: Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2886721 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721 | AUC0-∞ following administration of a single dose of 70 or 280 mg LY2886721. | Predose through 96 hours after administration of study drug |
| Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721 | Cmax following administration of a single dose of 70 or 280 mg LY2886721. | Predose through 96 hours after administration of study drug |
| Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid (CSF) LY2886721 | AUC0-∞ following administration of a single dose of 70 mg LY2886721. | Predose through 36 hours after administration of study drug |
| Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721 | Cmax following administration of a single dose of 70 mg LY2886721. | Predose through 36 hours after administration of study drug |
| Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40 | Plasma concentration of Aβ1-40 was summarized based on lowest observed concentration (Cnadir). | Predose, up to 96 hours after administration of study drug |
| PD: Cnadir of CSF Aβ 1-40 | Plasma concentration of Aβ1-40 was summarized based on Cnadir following administration of a single dose of 70 mg LY2886721 or a single dose of LY2886721-matching placebo. | Predose up to 36 hours after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort C: Mean QTcF Value at Cmax | The mean QTcF value at Cmax for participants administered a single dose of 280 mg LY2886721 was reported. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Time matched mean change from baseline in QTcF = time matched plasma concentration + participant + random error. |
Not provided
Inclusion Criteria:
Cohort A:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Salt Lake City | Utah |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: 70 mg LY2886721 | Participants with Alzheimer's disease received a single, 70-milligrams (mg) (1 capsule), oral dose of LY2886721. |
| FG001 | Cohort A: Placebo | Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule). |
| FG002 | Cohort B: 70 mg LY2886721 | Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721. |
| FG003 | Cohort B: Placebo | Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule). |
| FG004 | Cohort C: 280 mg LY2886721 | Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721. |
| FG005 | Cohort C: Placebo | Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: 70 mg LY2886721 | Participants with Alzheimer's disease received a single, 70-mg (1 capsule), oral dose of LY2886721. |
| BG001 | Cohort A: Placebo | Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721 | AUC0-∞ following administration of a single dose of 70 or 280 mg LY2886721. | Participants who received at least one dose of LY2886721 and with evaluable plasma LY2886721-concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/milliliter (ng*h/mL) | Predose through 96 hours after administration of study drug |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A: 70 mg LY2886721 | Participants with Alzheimer's disease received a single, 70-mg (1 capsule), oral dose of LY2886721. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Photophobia | Eye disorders | MedDRA 15.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000596181 | N-(3-(2-amino-4a,5,7,7a-tetrahydro-4H-furo(3,4-d)(1,3)thiazin-7a-yl)-4-fluorophenyl)-5-fluoropicolinamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules). |
|
| Drug |
|
| Predose up to 48 hours after administration of study drug |
| United States |
| BG002 | Cohort B: 70 mg LY2886721 | Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721. |
| BG003 | Cohort B: Placebo | Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule). |
| BG004 | Cohort C: 280 mg LY2886721 | Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721. |
| BG005 | Cohort C: Placebo | Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules). |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Cohort C: 280 mg LY2886721 | Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721. |
|
|
| Primary | Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721 | Cmax following administration of a single dose of 70 or 280 mg LY2886721. | Participants who received at least one dose of LY2886721 and with evaluable plasma LY2886721-concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Predose through 96 hours after administration of study drug |
|
|
|
| Primary | Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid (CSF) LY2886721 | AUC0-∞ following administration of a single dose of 70 mg LY2886721. | Participants who received at least one dose of LY2886721 at the 70-mg dose level and with evaluable CSF LY2886721-concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Predose through 36 hours after administration of study drug |
|
|
|
| Primary | Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721 | Cmax following administration of a single dose of 70 mg LY2886721. | Participants who received at least one dose of LY2886721 at the 70-mg dose level and with evaluable CSF LY2886721-concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose through 36 hours after administration of study drug |
|
|
|
| Primary | Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40 | Plasma concentration of Aβ1-40 was summarized based on lowest observed concentration (Cnadir). | Participants who received at least one dose of LY2886721 or placebo and had evaluable plasma Aβ 1-40 data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms/milliliter (pg/mL) | Predose, up to 96 hours after administration of study drug |
|
|
|
| Primary | PD: Cnadir of CSF Aβ 1-40 | Plasma concentration of Aβ1-40 was summarized based on Cnadir following administration of a single dose of 70 mg LY2886721 or a single dose of LY2886721-matching placebo. | Participants who received at least one dose of LY2886721 at the 70-mg dose level or placebo and had evaluable CSF Aβ 1-40 data. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Predose up to 36 hours after administration of study drug |
|
|
|
| Secondary | Cohort C: Mean QTcF Value at Cmax | The mean QTcF value at Cmax for participants administered a single dose of 280 mg LY2886721 was reported. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Time matched mean change from baseline in QTcF = time matched plasma concentration + participant + random error. | Participants who received at least one dose of LY2886721 at the 280-mg dose level and with evaluable mean QTcF data. | Posted | Mean | 90% Confidence Interval | milliseconds (ms) | Predose up to 48 hours after administration of study drug |
|
|
|
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | Cohort A: Placebo | Participants with Alzheimer's disease received a single, oral dose of LY2886721-matching placebo (1 capsule). | 0 | 2 | 1 | 2 |
| EG002 | Cohort B: 70 mg LY2886721 | Healthy participants received a single, 70-mg (1 capsule), oral dose of LY2886721. | 0 | 10 | 8 | 10 |
| EG003 | Cohort B: Placebo | Healthy participants received a single, oral dose of LY2886721-matching placebo (1 capsule). | 0 | 2 | 0 | 2 |
| EG004 | Cohort C: 280 mg LY2886721 | Healthy participants received a single, 280-mg (4 x 70 mg capsules), oral dose of LY2886721. | 0 | 9 | 1 | 9 |
| EG005 | Cohort C: Placebo | Healthy participants received a single, oral dose of LY2886721-matching placebo (4 capsules). | 0 | 3 | 0 | 3 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Red blood cells csf positive | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |