Alzheimer's DiseasePhase 1NCT01133405

A Safety Study of LY2886721 Single Doses in Healthy Subjects

A Phase 1 study testing LY2886721 in people with Alzheimer's Disease, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for: Alzheimer's Disease
What is being tested?: LY2886721
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Oct 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 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

Other trials in United States

About this study

Official title: Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects

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: Alzheimer's Disease
Being tested: LY2886721, Placebo
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2886721Drug
Oral capsules
PlaceboDrug
Oral capsules

Study groups in NCT01133405
Study group	Role	What they receive
LY2886721 Part 1: Cohort A/B	Experimental	Single (7 milligram (mg), 15 mg, 25 mg, 35 mg) doses of LY2886721 administered orally in up to three of three study periods Receives: Drug: LY2886721
Placebo Part 1: Cohort A/B	Placebo comparator	Single dose in up to 1 period Receives: Drug: Placebo
LY2886721 Part 2: Cohort C	Experimental	Single 10 mg dose of LY2886721, dose determined by Part 1 Receives: Drug: LY2886721
LY2886721 Part 2: Cohort D	Experimental	Single 35 mg dose of LY2886721, dose determined by Part 1 Receives: Drug: LY2886721
Placebo Part 2: Cohort C/D	Placebo comparator	Single dose Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Predose to 10-14 days after final dose of study drug (up to 42 days)

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: Predose and up to 36 hours postdose
Cerebrospinal Fluid (CSF) Area Under the Concentration Versus Time Curve (AUC) of LY2886721 (Part 2 Only)
Measured: Predose and up to 36 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Oct 2010

First posted28 May 2010 (estimated)
Study startJun 2010
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01133405
Sponsor's protocol ID: 13733
Other IDs: I4O-MC-BACA
Status last verified: May 2019
First submitted: 27 May 2010
Last updated: 16 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects
ClinicalTrials.gov ID: NCT01133405
Acronym / sponsor ID: 13733
Conditions: Alzheimer's Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 28 May 2010 (estimated)
Results: Posted 16 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
LY2886721 Part 1: Cohort A/B	Experimental	Drug: LY2886721Single (7 milligram (mg), 15 mg, 25 mg, 35 mg) doses of LY2886721 administered orally in up to three of three study periods
Placebo Part 1: Cohort A/B	Placebo comparator	Drug: PlaceboSingle dose in up to 1 period
LY2886721 Part 2: Cohort C	Experimental	Drug: LY2886721Single 10 mg dose of LY2886721, dose determined by Part 1
LY2886721 Part 2: Cohort D	Experimental	Drug: LY2886721Single 35 mg dose of LY2886721, dose determined by Part 1
Placebo Part 2: Cohort C/D	Placebo comparator	Drug: PlaceboSingle dose

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2886721Oral capsules	Drug	LY2886721 Part 1: Cohort A/B, LY2886721 Part 2: Cohort C, LY2886721 Part 2: Cohort D
PlaceboOral capsules	Drug	Placebo Part 1: Cohort A/B, Placebo Part 2: Cohort C/D

Primary outcome

Number of Participants With Clinically Significant Effects (Adverse Events)
Time frame: Predose to 10-14 days after final dose of study drug (up to 42 days)
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.

6 secondary outcomes

Maximum Observed Plasma Concentration (Cmax) of LY2886721
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)
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)
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)
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 and safety

Results posted to the registry on 16 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A (Part 1) : Sequence 1	3	2
Cohort A (Part 1): Sequence 2	6	3
Cohort A (Part 1): Sequence 3	5	4
Cohort B (Part 1): Sequence 1	5	1
Cohort B (Part 1): Sequence 2	3	3
Cohort B (Part 1): Sequence 3	5	3
Cohort C (Part 2): 10mg LY2886721	5	4
Cohort C (Part 2): Placebo	2	2
Cohort D (Part 2): 35 mg LY2886721	4	4
Cohort D (Part 2): Placebo	2	2

Primary outcome: Number of Participants With Clinically Significant Effects (Adverse Events)

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

Measure	Placebo (Part 1) n = 19	1 mg LY2886721 (Part 1) n = 8	7 mg LY2886721 (Part 1 - Fed and Fasted) n = 8	10 mg LY2886721 (Part 2) n = 4	15 mg LY2886721 (Part 1) n = 6	25 mg LY2886721 (Part 1) n = 7	35 mg LY2886721 (Part 1) n = 6	35 mg LY2886721 (Part 2) n = 4	Placebo (Part 2) n = 4
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

Population analysed: 39 of the 40 participants who were entered and randomized into the study and who had undergone study procedures were included in the safety analyses. One participant, who was entered and randomized into the study but did not undergo study procedures, was excluded from the analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Part 1)	0 of 19 (0%)	4 of 19 (21.1%)	Not reported
1 mg LY2886721 (Part 1)	0 of 8 (0%)	2 of 8 (25%)	Not reported
7 mg LY2886721 (Part 1 - Fed and Fasted)	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
10 mg LY2886721 (Part 2)	0 of 4 (0%)	1 of 4 (25%)	Not reported
15 mg LY2886721 (Part 1)	0 of 6 (0%)	0 of 6 (0%)	Not reported
25 mg LY2886721 (Part 1)	0 of 7 (0%)	1 of 7 (14.3%)	Not reported
35 mg LY2886721 (Part 1)	0 of 6 (0%)	3 of 6 (50%)	Not reported
35 mg LY2886721 (Part 2)	0 of 4 (0%)	4 of 4 (100%)	Not reported
Placebo (Part 2)	0 of 4 (0%)	3 of 4 (75%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2886721 in people with Alzheimer's Disease, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinically Significant Effects (Adverse Events) (time frame: Predose to 10-14 days after final dose of study drug (up to 42 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01133405.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.