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| ID | Type | Description | Link |
|---|---|---|---|
| I4O-MC-BACJ | Other Identifier | Eli Lilly and Company |
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The purpose of this phase I study in healthy participants will be to evaluate the safety and tolerability of LY2886721 single and multiple doses, to evaluate how the body handles the drug, and to evaluate the drug's effect on the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single oral dose and/or once daily (QD) oral dosing for 14 consecutive days |
|
| 35 mg LY2886721 | Experimental | QD oral dosing for 14 consecutive days |
|
| 70 mg LY2886721 | Experimental | Single oral dose or single oral dose followed by QD oral dosing for 14 consecutive days |
|
| 140 mg LY2886721 | Experimental | Single oral dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2886721 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Effects | Data presented are the number of participants who experienced treatment-emergent adverse events. A summary of serious adverse events and other non-serious adverse events, regardless of causality is reported in the Adverse Events module. | Predose up to Day 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Plasma Maximum Observed Concentration (Cmax) of LY2886721 | Day 1 predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose | |
| Pharmacokinetics: Plasma Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of LY2886721 |
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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 |
|---|---|---|---|---|---|---|
| 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. | Glendale | California | 91206 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Cohort A) | Placebo: once daily (QD) oral dosing for 14 consecutive days |
| FG001 | 35 mg LY2886721 (Cohort A) | 35 milligrams (mg) LY2886721: QD oral dosing for 14 consecutive days |
| FG002 | Placebo (Cohort B) | Placebo: single oral dose (Period 1) followed by QD oral dosing for 14 consecutive days (Period 2) |
| FG003 | 70 mg LY2886721 (Cohort B) | 70 mg LY2886721: single oral dose (Period 1) followed by QD oral dosing for 14 consecutive days (Period 2) |
| FG004 | Placebo (Cohort C) | Placebo: single oral dose |
| FG005 | 70 mg LY2886721 (Cohort C) | 70 mg LY2886721: single oral dose |
| FG006 | 140 mg LY2886721 (Cohort C) | 140 mg LY2886721: single oral dose |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| |||||||||||||||||||||
| Period 2 |
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: once daily (QD) oral dosing for 14 consecutive days |
| BG001 | 35 mg LY2886721 | Participants received 35 mg LY2886721: oral dosing for 14 consecutive days |
| 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 Clinically Significant Effects | Data presented are the number of participants who experienced treatment-emergent adverse events. A summary of serious adverse events and other non-serious adverse events, regardless of causality is reported in the Adverse Events module. | All enrolled participants. Ten participants, 7 in Cohort B and 3 in Cohort C, received 70 mg LY2886721 as a single dose. Six of the participants in Cohort B went on to receive QD dosing for 14 consecutive days. These 6 participants are included in the 70 mg LY2886721 Single Dose arm and the 70 mg LY2886721 Multiple Dose arm. | Posted | Count of Participants | Participants | No | Predose up to Day 23 |
|
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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 | Placebo | Placebo: QD oral dosing for 14 consecutive days (Cohort A), single oral dose (Period 1) followed by QD oral dosing for 14 consecutive days (Period 2) (Cohort B), or single oral dose (Cohort C) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Scotoma | Eye disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| 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 |
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| Placebo | Drug | Administered orally. |
|
| Day 1 predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
| Pharmacokinetics: Plasma Maximum Observed Concentration at Steady State (Cmax,ss) of LY2886721 | Day 14 predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose |
| Pharmacokinetics: Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721 | AUC over the dosing interval at steady state (AUCtau,ss) is reported for participants who received multiple doses of LY2886721. | Day 14 predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose |
| Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid 1-40 Concentration at Day 15 | Least squares (LS) mean percent changes from baseline to Day 15 in CSF amyloid 1-40 concentrations for participants in Cohort B are reported. LS means were calculated from an analysis of covariance (ANCOVA) with treatment group and predose CSF amyloid 1-40 concentration as fixed effects. The 95% confidence interval (CI) of the percent change from baseline was computed by back-transforming the mean difference between endpoint and baseline. | Baseline, Day 15 |
| Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid 1-40 Concentration at 24 Hours Post-dose | LS mean percent changes from baseline to 24 hours post-dose in CSF amyloid 1-40 concentrations for participants in Cohort C are reported. LS means were calculated from an ANCOVA with treatment group and predose CSF amyloid 1-40 concentration as fixed effects. The 95% CI of the percent change from baseline was computed by back-transforming the mean difference between endpoint and baseline. | Baseline, 24 hours post-dose |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| BG002 | 70 mg LY2886721 | Participants received 70 mg LY2886721: single oral dose followed by QD oral dosing for 14 consecutive days or single oral dose. |
| BG003 | 140 mg LY2886721 | Participants received 140 mg LY2886721: single oral dose |
| BG004 | 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 | 35 mg LY2886721 | 35 mg LY2886721: QD oral dosing for 14 consecutive days (Cohort A) |
| OG002 | 70 mg LY2886721 Multiple Dose | 70 mg LY2886721: single oral dose (Period 1) followed by QD oral dosing for 14 consecutive days (Period 2) (Cohort B) |
| OG003 | 70 mg LY2886721 Single Dose | 70 mg LY2886721: single oral dose (Cohort B [Period 1] and Cohort C) |
| OG004 | 140 mg LY2886721 | 140 mg LY2886721: single oral dose (Cohort C) |
|
|
| Secondary | Pharmacokinetics: Plasma Maximum Observed Concentration (Cmax) of LY2886721 | All randomized participants who received a single 70- or 140-mg dose of LY2886721 and had evaluable single-dose LY2886721 concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Day 1 predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Plasma Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of LY2886721 | All randomized participants who received a single 70- or 140-mg dose of LY2886721 and had evaluable single-dose LY2886721 concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/milliliter (ng*hr/mL) | Day 1 predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Plasma Maximum Observed Concentration at Steady State (Cmax,ss) of LY2886721 | All randomized participants who received LY2886721 and had evaluable steady-state plasma LY2886721 concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 14 predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721 | AUC over the dosing interval at steady state (AUCtau,ss) is reported for participants who received multiple doses of LY2886721. | All randomized participants who received LY2886721 and had evaluable steady-state plasma LY2886721 concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 14 predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose |
|
|
|
| Secondary | Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid 1-40 Concentration at Day 15 | Least squares (LS) mean percent changes from baseline to Day 15 in CSF amyloid 1-40 concentrations for participants in Cohort B are reported. LS means were calculated from an analysis of covariance (ANCOVA) with treatment group and predose CSF amyloid 1-40 concentration as fixed effects. The 95% confidence interval (CI) of the percent change from baseline was computed by back-transforming the mean difference between endpoint and baseline. | All randomized participants in Cohort B who received multiple doses of placebo or 70 mg LY2886721 and had evaluable CSF amyloid 1-40 concentrations. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline, Day 15 |
|
|
|
| Secondary | Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid 1-40 Concentration at 24 Hours Post-dose | LS mean percent changes from baseline to 24 hours post-dose in CSF amyloid 1-40 concentrations for participants in Cohort C are reported. LS means were calculated from an ANCOVA with treatment group and predose CSF amyloid 1-40 concentration as fixed effects. The 95% CI of the percent change from baseline was computed by back-transforming the mean difference between endpoint and baseline. | All randomized participants in Cohort C who received placebo or LY2886721 and had measurable CSF amyloid 1-40 concentration data. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline, 24 hours post-dose |
|
|
|
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | 35 mg LY2886721 | 35 mg LY2886721: QD oral dosing for 14 consecutive days (Cohort A) | 0 | 6 | 1 | 6 |
| EG002 | 70 mg LY2886721 Multiple Dose | 70 mg LY2886721: single oral dose (Period 1) followed by QD oral dosing for 14 consecutive days (Period 2) (Cohort B) | 0 | 6 | 3 | 6 |
| EG003 | 70 mg LY2886721 Single Dose | 70 mg LY2886721: single oral dose(Cohort B [Period 1] and Cohort C) | 0 | 10 | 2 | 10 |
| EG004 | 140 mg LY2886721 | 140 mg LY2886721: single oral dose (Cohort C) | 0 | 6 | 1 | 6 |
| Dry mouth | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Procedural headache | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA 14.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
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