Alzheimer's DiseasePhase 1NCT01227252
A Safety Study of LY2886721 Multiple 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.
Trial summary
This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 multiple 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
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Apr 2011
- 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 non-childbearing potential women
- Body mass index between 18.0-32.0 kilograms per square meter (kg/m^2)
- Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies
Who cannot join
- Taking over-the-counter or prescription medication with the exception of vitamins or minerals
- Smoke more than 10 cigarettes per day
- Drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) 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.
Glendale, California, 91206
About this study
Official title: Multiple-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 multiple doses, how the body handles the drug, and the drug's effect on the body.
- 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
5 milligrams (mg) up to 35 mg, administered orally as capsules, daily for 14 days
PlaceboDrug
Administered orally as capsules, daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| LY2886721 | Experimental | Not described Receives: Drug: LY2886721 |
| Placebo | Placebo comparator | Not described 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
Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module. The number of participants with at least 1 adverse event in each treatment arm is reported for this outcome measure.
Measured: Predose up to Day 70
Secondary outcomes (5)
Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721
Measured: Predose (Day 14) up to Day 19
Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721
Area under the concentration versus time curve during 1 dosing interval (1 dosing interval=24 hours) at steady state (AUCτ,ss) is being reported for this outcome measure.
Measured: Predose (Day 14) to 24 Hours post-dose (Day 15)
Plasma Amyloid Beta (Aβ) 1-40 Concentration
The minimum concentration (Cnadir) is being reported for this outcome measure.
Measured: Predose (Day 14) up to Day 19
Cerebrospinal Fluid (CSF) Concentration of LY2886721
Measured: 24 Hours post-dose (Day 15)
Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration
The Least Squares means were adjusted for baseline concentration.
Measured: Predose (Day 14), 24 Hours post-dose (Day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2011
- Study completionApr 2011
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227252
- Sponsor's protocol ID
- 13734
- Other IDs
- I4O-MC-BACB
- Status last verified
- May 2019
- First submitted
- 21 Oct 2010
- Last updated
- 19 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2886721 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01227252
- Acronym / sponsor ID
- 13734
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 Oct 2010 (estimated)
- Results
- Posted 19 Jul 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 multiple doses, how the body handles the drug, and the drug's effect on the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY2886721 | Experimental | Drug: LY2886721 |
| Placebo | Placebo comparator | Drug: Placebo |
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 non-childbearing potential women
- Body mass index between 18.0-32.0 kilograms per square meter (kg/m^2)
- Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies
Key exclusion criteria (3 listed)
- Taking over-the-counter or prescription medication with the exception of vitamins or minerals
- Smoke more than 10 cigarettes per day
- Drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) 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 |
|---|---|---|
| LY28867215 milligrams (mg) up to 35 mg, administered orally as capsules, daily for 14 days | Drug | LY2886721 |
| PlaceboAdministered orally as capsules, daily for 14 days | Drug | Placebo |
Primary outcome
Number of Participants With Clinically Significant Effects
Time frame: Predose up to Day 70
Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module. The number of participants with at least 1 adverse event in each treatment arm is reported for this outcome measure.
5 secondary outcomes
Plasma Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY2886721
Time frame: Predose (Day 14) up to Day 19
Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721
Time frame: Predose (Day 14) to 24 Hours post-dose (Day 15)
Plasma Amyloid Beta (Aβ) 1-40 Concentration
Time frame: Predose (Day 14) up to Day 19
Cerebrospinal Fluid (CSF) Concentration of LY2886721
Time frame: 24 Hours post-dose (Day 15)
Change From Baseline to Day 15 Endpoint in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ) 1-40 Concentration
Time frame: Predose (Day 14), 24 Hours post-dose (Day 15)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 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 3 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 19 Jul 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 19 Jul 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 (time frame: Predose up to Day 70). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2019.