CompletedNCT01133405Updated Sep 16, 2019Results posted

A Safety Study of LY2886721 Single Doses in Healthy Subjects

A Phase 1 interventional study of LY2886721 and Placebo in Alzheimer's Disease, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-16.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study summary

This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 single doses, how the body handles the drug, and the drug's effect on the body.

Read the detailed description

This is a Phase 1 study with 2 parts, both in healthy subjects. Part 1 is a subject- and investigator-blind, placebo-controlled, randomized, 3-period, crossover study. Part 1 will assess the safety and tolerability of LY2886721 single doses, how the body handles the drug, and the drug's effect on the body. Part 2 is a subject- and investigator-blind, placebo-controlled, randomized study to assess the safety and tolerability of an LY2886721 single dose, how the body handles the drug, and the drug's effect on the body including in cerebrospinal fluid.

Conditions studied

Alzheimer's Disease

Browse trials for

Alzheimer Disease 3,678

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 40 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy men and nonchild-bearing potential women
20 years or older
Body mass index between 18-32 kilograms per square meter (kg/m\^2)

Exclusion criteria

Exclusion Criteria:

Taking over-the-counter or prescription medication with the exception of vitamins or minerals or stable doses of thyroid or estrogen hormone replacement
Smoke more than 10 cigarettes per day

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 40 participants (actual)

Study arms

Experimental
LY2886721 Part 1: Cohort A/B
Single (7 milligram (mg), 15 mg, 25 mg, 35 mg) doses of LY2886721 administered orally in up to three of three study periods
Drug: LY2886721
Placebo comparator
Placebo Part 1: Cohort A/B
Single dose in up to 1 period
Drug: Placebo
Experimental
LY2886721 Part 2: Cohort C
Single 10 mg dose of LY2886721, dose determined by Part 1
Drug: LY2886721
Experimental
LY2886721 Part 2: Cohort D
Single 35 mg dose of LY2886721, dose determined by Part 1
Drug: LY2886721
Placebo comparator
Placebo Part 2: Cohort C/D
Single dose
Drug: Placebo

Interventions

DrugLY2886721
Oral capsules
DrugPlacebo
Oral capsules

What researchers measure

Primary outcomes

Number of Participants With Clinically Significant Effects (Adverse Events)
A summary of serious adverse events and other nonserious adverse events located in Reported Adverse Event section. To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in other LY2886721 groups received LY2886721 in fasted state. Due to crossover design in Part 1, results reported by treatment; thus, participants are included in multiple arms.
Time frame: Predose to 10-14 days after final dose of study drug (up to 42 days)

Secondary outcomes

Maximum Observed Plasma Concentration (Cmax) of LY2886721
To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in the other LY2886721 groups received LY2886721 in the fasted state. Due to the crossover design in Part 1, results are reported by treatment; therefore, participants are included in multiple arms.
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose
Plasma Concentration of LY2886721: Area Under the Concentration Versus Time Curve (AUC)
Pharmacokinetic AUC for LY2886721 from time 0 to infinity. To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in the other LY2886721 groups received LY2886721 in the fasted state. Due to the crossover design in Part 1, results are reported by treatment; therefore, participants are included in multiple arms.
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose
Pharmacodynamic Biomarker: Plasma Amyloid Beta (Aβ) 1-40 Concentration (Part 1 Only)
Plasma concentrations of Aβ1-40 were based on the lowest observed/measured concentration (Cnadir). To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in the other LY2886721 groups received LY2886721 in the fasted state. Due to the crossover design in Part 1, results are reported by treatment; therefore, participants are included in multiple arms.
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose
Cerebrospinal Fluid (CSF) Maximum Observed Drug Concentration (Cmax) of LY2886721 (Part 2 Only)
Time frame: Predose and up to 36 hours postdose
Cerebrospinal Fluid (CSF) Pharmacodynamic Biomarker Amyloid Beta (Aβ) 1-40 Concentration (Part 2 Only)
CSF Aβ 1-40 concentration was based on the lowest observed/measured concentration (Cnadir).
Time frame: Predose and up to 36 hours postdose
Cerebrospinal Fluid (CSF) Area Under the Concentration Versus Time Curve (AUC) of LY2886721 (Part 2 Only)
Time frame: Predose and up to 36 hours postdose

Results

Posted Sep 16, 2019

Participant flow

Period 1

Participant flow — Period 1
Milestone	Cohort A (Part 1) : Sequence 1	Cohort A (Part 1): Sequence 2	Cohort A (Part 1): Sequence 3	Cohort B (Part 1): Sequence 1	Cohort B (Part 1): Sequence 2	Cohort B (Part 1): Sequence 3	Cohort C (Part 2): 10mg LY2886721	Cohort C (Part 2): Placebo	Cohort D (Part 2): 35 mg LY2886721	Cohort D (Part 2): Placebo
Started	3	6	5	5	3	5	5	2	4	2
Safety analysis population	2	6	5	5	3	5	5	2	4	2
Received at least 1 dose of drug	2	4	4	3	3	4	4	2	4	2
Completed	2	3	4	1	3	3	4	2	4	2
Not completed	1	3	1	4	0	2	1	0	0	0
Withdrew: Withdrawal by subject	0	1	0	1	0	1	0	0	0	0
Withdrew: Physician decision	0	0	0	1	0	0	0	0	0	0
Withdrew: Discontinued after randomization	1	0	0	0	0	0	1	0	0	0
Withdrew: Received drug only in period 2	0	1	0	2	0	1	0	0	0	0
Withdrew: Received drug only in period 3	0	1	1	0	0	0	0	0	0	0

Period 2

Participant flow — Period 2
Milestone	Cohort A (Part 1) : Sequence 1	Cohort A (Part 1): Sequence 2	Cohort A (Part 1): Sequence 3	Cohort B (Part 1): Sequence 1	Cohort B (Part 1): Sequence 2	Cohort B (Part 1): Sequence 3
Started	2	4	4	3	3	4
Received at least 1 dose of study drug	2	4	4	3	3	4
Completed	2	3	3	2	3	2
Not completed	0	1	1	1	0	2
Withdrew: Adverse event	0	0	1	0	0	0
Withdrew: Withdrawal by subject	0	0	0	1	0	1
Withdrew: Entry criteria not met	0	1	0	0	0	0
Withdrew: Physician decision	0	0	0	0	0	1

Period 3

Participant flow — Period 3
Milestone	Cohort A (Part 1) : Sequence 1	Cohort A (Part 1): Sequence 2	Cohort A (Part 1): Sequence 3	Cohort B (Part 1): Sequence 1	Cohort B (Part 1): Sequence 2	Cohort B (Part 1): Sequence 3
Started	2	4	4	2	3	2
Received at least 1 dose of study drug	2	4	4	2	3	2
Completed	2	4	4	2	3	2
Not completed	0	0	0	0	0	0

Outcome measures

PrimaryNumber of Participants With Clinically Significant Effects (Adverse Events)

A summary of serious adverse events and other nonserious adverse events located in Reported Adverse Event section. To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in other LY2886721 groups received LY2886721 in fasted state. Due to crossover design in Part 1, results reported by treatment; thus, participants are included in multiple arms.

Time frame:: Predose to 10-14 days after final dose of study drug (up to 42 days)
Reported as:: Count of participants · Participants

Number of Participants With Clinically Significant Effects (Adverse Events)
Participants	Placebo (Part 1)	1 mg LY2886721 (Part 1)	7 mg LY2886721 (Part 1 - Fed and Fasted)	10 mg LY2886721 (Part 2)	15 mg LY2886721 (Part 1)	25 mg LY2886721 (Part 1)	35 mg LY2886721 (Part 1)	35 mg LY2886721 (Part 2)	Placebo (Part 2)
Serious Adverse Events	0	0	0	0	0	0	0	0	0
Other Nonserious Adverse Events	4	2	1	1	0	1	3	4	3

SecondaryMaximum Observed Plasma Concentration (Cmax) of LY2886721

To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in the other LY2886721 groups received LY2886721 in the fasted state. Due to the crossover design in Part 1, results are reported by treatment; therefore, participants are included in multiple arms.

Time frame:: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose
Reported as:: Geometric mean · nanogram per milliliter (ng/mL)

Maximum Observed Plasma Concentration (Cmax) of LY2886721
nanogram per milliliter (ng/mL)	1 mg LY2886721 (Part 1)	7 mg LY2886721 Fed (Part 1)	7 mg LY2886721 Fasted (Part 1)	10 mg LY2886721 (Part 2)	15 mg LY2886721 (Part 1)	25 mg LY2886721 (Part 1)	35 mg LY2886721 (Part 1)	35 mg LY2886721 (Part 2)
Maximum Observed Plasma Concentration (Cmax) of LY2886721	1.9 ± 65	22.5 ± 23	18.2 ± 64	6.6 ± 60	41.6 ± 24	79.1 ± 25	78.2 ± 45	53.3 ± 44

SecondaryPlasma Concentration of LY2886721: Area Under the Concentration Versus Time Curve (AUC)

Pharmacokinetic AUC for LY2886721 from time 0 to infinity. To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in the other LY2886721 groups received LY2886721 in the fasted state. Due to the crossover design in Part 1, results are reported by treatment; therefore, participants are included in multiple arms.

Time frame:: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose
Reported as:: Geometric mean · nanogram*hour per milliliter (ng*h/mL)

Plasma Concentration of LY2886721: Area Under the Concentration Versus Time Curve (AUC)
nanogramhour per milliliter (ngh/mL)	1 mg LY2886721 (Part 1)	7 mg LY2886721 Fed (Part 1)	7 mg LY2886721 Fasted (Part 1)	10 mg LY2886721 (Part 2)	15 mg LY2886721 (Part 1)	25 mg LY2886721 (Part 1)	35 mg LY2886721 (Part 1)	35 mg LY2886721 (Part 2)
Plasma Concentration of LY2886721: Area Under the Concentration Versus Time Curve (AUC)	NA ± NA	311 ± 14	212 ± 41	144 ± 580	468 ± 20	926 ± 16	954 ± 37	800 ± 38

SecondaryPharmacodynamic Biomarker: Plasma Amyloid Beta (Aβ) 1-40 Concentration (Part 1 Only)

Plasma concentrations of Aβ1-40 were based on the lowest observed/measured concentration (Cnadir). To assess effect of food on pharmacokinetics of LY2886721, participants in Cohort B during Period 3 (1 period=8 days) of Part 1 fasted overnight for at least 8 hours prior to receiving a single 7-milligram (mg) oral dose of LY2886721 in the fed state (Part 1 - Fed). Participants in the other LY2886721 groups received LY2886721 in the fasted state. Due to the crossover design in Part 1, results are reported by treatment; therefore, participants are included in multiple arms.

Time frame:: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 60 and 96 hours post-dose
Reported as:: Geometric mean · picogram per milliliter (pg/mL)

Pharmacodynamic Biomarker: Plasma Amyloid Beta (Aβ) 1-40 Concentration (Part 1 Only)
picogram per milliliter (pg/mL)	Placebo (Part 1)	1 mg LY2886721 (Part 1)	7 mg LY2886721 (Part 1 - Fed and Fasted)	15 mg LY2886721 (Part 1)	25 mg LY2886721 (Part 1)	35 mg LY2886721 (Part 1)
Pharmacodynamic Biomarker: Plasma Amyloid Beta (Aβ) 1-40 Concentration (Part 1 Only)	121 ± 23.6	80 ± 19.5	56 ± 41.3	35 ± 37.7	34 ± 28.4	36 ± 11.7

SecondaryCerebrospinal Fluid (CSF) Maximum Observed Drug Concentration (Cmax) of LY2886721 (Part 2 Only)

Time frame:: Predose and up to 36 hours postdose
Reported as:: Geometric mean · nanogram per milliliter (ng/mL)

Cerebrospinal Fluid (CSF) Maximum Observed Drug Concentration (Cmax) of LY2886721 (Part 2 Only)
nanogram per milliliter (ng/mL)	10 mg LY2886721 (Part 2)	35 mg LY2886721 (Part 2)
Cerebrospinal Fluid (CSF) Maximum Observed Drug Concentration (Cmax) of LY2886721 (Part 2 Only)	0.93 ± 60	5.99 ± 39

SecondaryCerebrospinal Fluid (CSF) Pharmacodynamic Biomarker Amyloid Beta (Aβ) 1-40 Concentration (Part 2 Only)

CSF Aβ 1-40 concentration was based on the lowest observed/measured concentration (Cnadir).

Time frame:: Predose and up to 36 hours postdose
Reported as:: Geometric mean · picogram per milliliter (pg/mL)

Cerebrospinal Fluid (CSF) Pharmacodynamic Biomarker Amyloid Beta (Aβ) 1-40 Concentration (Part 2 Only)
picogram per milliliter (pg/mL)	10 mg LY2886721 (Part 2)	35 mg LY2886721 (Part 2)	Placebo (Part 2)
Cerebrospinal Fluid (CSF) Pharmacodynamic Biomarker Amyloid Beta (Aβ) 1-40 Concentration (Part 2 Only)	8080 ± 48.8	5650 ± 51.1	7150 ± 62.4

SecondaryCerebrospinal Fluid (CSF) Area Under the Concentration Versus Time Curve (AUC) of LY2886721 (Part 2 Only)

Time frame:: Predose and up to 36 hours postdose
Reported as:: Geometric mean · nanogram*hour per milliliter (ng*h/mL)

Cerebrospinal Fluid (CSF) Area Under the Concentration Versus Time Curve (AUC) of LY2886721 (Part 2 Only)
nanogramhour per milliliter (ngh/mL)	10 mg LY2886721 (Part 2)	35 mg LY2886721 (Part 2)
Cerebrospinal Fluid (CSF) Area Under the Concentration Versus Time Curve (AUC) of LY2886721 (Part 2 Only)	27 ± 89	121 ± 30

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo (Part 1)	—	0/19 (0%)	4/19 (21.1%)
1 mg LY2886721 (Part 1)	—	0/8 (0%)	2/8 (25%)
7 mg LY2886721 (Part 1 - Fed and Fasted)	—	0/8 (0%)	1/8 (12.5%)
10 mg LY2886721 (Part 2)	—	0/4 (0%)	1/4 (25%)
15 mg LY2886721 (Part 1)	—	0/6 (0%)	0/6 (0%)
25 mg LY2886721 (Part 1)	—	0/7 (0%)	1/7 (14.3%)
35 mg LY2886721 (Part 1)	—	0/6 (0%)	3/6 (50%)
35 mg LY2886721 (Part 2)	—	0/4 (0%)	4/4 (100%)
Placebo (Part 2)	—	0/4 (0%)	3/4 (75%)

Most frequent other events

Showing 10 of 19

Most frequent other events
Event	Placebo (Part 1)	1 mg LY2886721 (Part 1)	7 mg LY2886721 (Part 1 - Fed and Fasted)	10 mg LY2886721 (Part 2)	15 mg LY2886721 (Part 1)	25 mg LY2886721 (Part 1)	35 mg LY2886721 (Part 1)	35 mg LY2886721 (Part 2)	Placebo (Part 2)
Procedural headacheInjury, poisoning and procedural complications	0/19	0/8	0/8	1/4	0/6	0/7	0/6	4/4	1/4
Chest painGeneral disorders	0/19	0/8	0/8	0/4	0/6	0/7	0/6	0/4	1/4
Puncture site painGeneral disorders	0/19	0/8	0/8	1/4	0/6	0/7	0/6	1/4	0/4
Procedural vomitingInjury, poisoning and procedural complications	0/19	0/8	0/8	0/4	0/6	0/7	0/6	1/4	0/4
ArthralgiaMusculoskeletal and connective tissue disorders	0/19	0/8	0/8	0/4	0/6	0/7	0/6	1/4	0/4
Muscle spasmsMusculoskeletal and connective tissue disorders	0/19	0/8	0/8	1/4	0/6	0/7	1/6	0/4	0/4
HeadacheNervous system disorders	1/19	1/8	0/8	0/4	0/6	0/7	0/6	0/4	1/4
SyncopeNervous system disorders	0/19	0/8	0/8	0/4	0/6	0/7	0/6	0/4	1/4
Pain in extremityMusculoskeletal and connective tissue disorders	0/19	0/8	0/8	0/4	0/6	0/7	1/6	0/4	0/4
DizzinessNervous system disorders	1/19	0/8	0/8	0/4	0/6	0/7	1/6	0/4	0/4

Baseline characteristics

Safety analysis population

Age, Categorical
Age, Categorical(Participants)	Cohort A (Part 1): Sequence 1	Cohort A (Part 1): Sequence 2	Cohort A (Part 1): Sequence 3	Cohort B (Part 1): Sequence 1	Cohort B (Part 1): Sequence 2	Cohort B (Part 1): Sequence 3	Cohort C (Part 2): 10mg LY2886721	Cohort C (Part 2): Placebo	Cohort D (Part 2): 35 mg LY2886721	Cohort D (Part 2): Placebo	Total
<=18 years	0	0	0	0	0	0	0	0	0	0	0
Between 18 and 65 years	2	6	5	5	3	5	5	2	4	2	39
>=65 years	0	0	0	0	0	0	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort A (Part 1): Sequence 1	Cohort A (Part 1): Sequence 2	Cohort A (Part 1): Sequence 3	Cohort B (Part 1): Sequence 1	Cohort B (Part 1): Sequence 2	Cohort B (Part 1): Sequence 3	Cohort C (Part 2): 10mg LY2886721	Cohort C (Part 2): Placebo	Cohort D (Part 2): 35 mg LY2886721	Cohort D (Part 2): Placebo	Total
Female	0	0	3	0	2	0	1	1	0	0	7
Male	2	6	2	5	1	5	4	1	4	2	32

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cohort A (Part 1): Sequence 1	Cohort A (Part 1): Sequence 2	Cohort A (Part 1): Sequence 3	Cohort B (Part 1): Sequence 1	Cohort B (Part 1): Sequence 2	Cohort B (Part 1): Sequence 3	Cohort C (Part 2): 10mg LY2886721	Cohort C (Part 2): Placebo	Cohort D (Part 2): 35 mg LY2886721	Cohort D (Part 2): Placebo	Total
American Indian or Alaska Native	0	0	0	1	0	0	0	0	1	0	2
Asian	1	3	1	3	0	3	0	0	0	0	11
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0
Black or African American	0	2	0	1	0	2	4	2	1	1	13
White	1	1	3	0	2	0	1	0	2	1	11
More than one race	0	0	1	0	1	0	0	0	0	0	2
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Cohort A (Part 1): Sequence 1	Cohort A (Part 1): Sequence 2	Cohort A (Part 1): Sequence 3	Cohort B (Part 1): Sequence 1	Cohort B (Part 1): Sequence 2	Cohort B (Part 1): Sequence 3	Cohort C (Part 2): 10mg LY2886721	Cohort C (Part 2): Placebo	Cohort D (Part 2): 35 mg LY2886721	Cohort D (Part 2): Placebo	Total
United States	2	6	5	5	3	5	5	2	4	2	39

Study locations

1 site

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.
Beverly Hills, California 90211, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01133405
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: May 28, 2010
Start date: Jun 2010
Primary completion: Oct 2010
Completion: Oct 2010
Results posted: Sep 16, 2019
Last update: Sep 16, 2019

Study contacts

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)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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