Alzheimer's DiseasePhase 1NCT00838084
A Safety Study of LY2811376 Single Doses in Healthy Subjects
A Phase 1 study testing LY2811376 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 LY2811376 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 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- LY2811376
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- 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 18-32kg/m2
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.
- Consume more than 5 cups of coffee 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
About this study
Official title: Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY2811376 in Healthy Subjects
This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2811376 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 LY2811376 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 a LY2811376 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
- LY2811376, 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.
LY2811376Drug
Oral capsules
PlaceboDrug
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| LY2811376 Part 1 | Experimental | LY2811376 (5 mg up to 500 mg); once a day or twice a day for 1 day in up to 3 periods. Receives: Drug: LY2811376 |
| Placebo Part 1 | Placebo comparator | once a day or twice a day for 1 day in up to 3 periods. Receives: Drug: Placebo |
| LY2811376 - Part 2 low dose | Experimental | Single dose of LY2811376, dose determined by part 1 Receives: Drug: LY2811376 |
| LY2811376 - Part 2 high dose | Experimental | Single dose of LY2811376, dose determined by part 1 Receives: Drug: LY2811376 |
| Placebo Part 2 | Placebo comparator | single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Effects
Measured: Predose and up to Day 6 of each period
Secondary outcomes (6)
Plasma concentration of LY2811376 (Cmax)
Measured: Predose and up to Day 6 of each period
Plasma concentration of LY2811376 (AUC)
Measured: Predose and up to Day 6 of each period
Amyloid beta 1-40 plasma concentrations
Measured: Predose and up to Day 6 of each period
Cerebrospinal fluid (CSF) concentration of LY2811376 (Cmax) (Part 2 only)
Measured: Predose and up to 36 hours
Cerebrospinal fluid (CSF) concentration of LY2811376 (AUC) (Part 2 only)
Measured: Predose and up to 36 hours
Amyloid beta 1-40 cerebrospinal fluid CSF concentrations (Part 2 only)
Measured: Predose and up to 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- NCT00838084
- Sponsor's protocol ID
- 12852
- Other IDs
- I3J-MC-LACE
- Status last verified
- Jul 2009
- First submitted
- 23 Jan 2009
- Last updated
- 15 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Portelius E, Dean RA, Andreasson U, Mattsson N, Westerlund A, Olsson M, Demattos RB, Racke MM, Zetterberg H, May PC, Blennow K. beta-site amyloid precursor protein-cleaving enzyme 1(BACE1) inhibitor treatment induces Abeta5-X peptides through alternative amyloid precursor protein cleavage. Alzheimers Res Ther. 2014 Nov 17;6(5-8):75. doi: 10.1186/s13195-014-0075-0. eCollection 2014.
PubMed 25404952
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. 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 LY2811376 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00838084
- Acronym / sponsor ID
- 12852
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Not posted in the source record
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 LY2811376 single doses, how the body handles the drug, and the drug's effect on the body.
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 LY2811376 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 a LY2811376 single dose, how the body handles the drug, and the drug's effect on the body including in cerebrospinal fluid.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| LY2811376 Part 1 | Experimental | Drug: LY2811376LY2811376 (5 mg up to 500 mg); once a day or twice a day for 1 day in up to 3 periods. |
| Placebo Part 1 | Placebo comparator | Drug: Placeboonce a day or twice a day for 1 day in up to 3 periods. |
| LY2811376 - Part 2 low dose | Experimental | Drug: LY2811376Single dose of LY2811376, dose determined by part 1 |
| LY2811376 - Part 2 high dose | Experimental | Drug: LY2811376Single dose of LY2811376, dose determined by part 1 |
| Placebo Part 2 | Placebo comparator | Drug: Placebosingle dose |
Who may qualify
- Ages
- 20 to 65 years
- 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 18-32kg/m2
Key exclusion criteria (3 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.
- Consume more than 5 cups of coffee 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 |
|---|---|---|
| LY2811376Oral capsules | Drug | LY2811376 - Part 2 high dose, LY2811376 - Part 2 low dose, LY2811376 Part 1 |
| PlaceboOral capsules | Drug | Placebo Part 1, Placebo Part 2 |
Primary outcome
Clinical Effects
Time frame: Predose and up to Day 6 of each period
6 secondary outcomes
Plasma concentration of LY2811376 (Cmax)
Time frame: Predose and up to Day 6 of each period
Plasma concentration of LY2811376 (AUC)
Time frame: Predose and up to Day 6 of each period
Amyloid beta 1-40 plasma concentrations
Time frame: Predose and up to Day 6 of each period
Cerebrospinal fluid (CSF) concentration of LY2811376 (Cmax) (Part 2 only)
Time frame: Predose and up to 36 hours
Cerebrospinal fluid (CSF) concentration of LY2811376 (AUC) (Part 2 only)
Time frame: Predose and up to 36 hours
Amyloid beta 1-40 cerebrospinal fluid CSF concentrations (Part 2 only)
Time frame: Predose and up to 36 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2009.
- Derived from this study: PubMed 25404952Portelius E, Dean RA, Andreasson U, Mattsson N, Westerlund A, Olsson M, Demattos RB, Racke MM, Zetterberg H, May PC, Blennow K. beta-site amyloid precursor protein-cleaving enzyme 1(BACE1) inhibitor treatment induces Abeta5-X peptides through alternative amyloid precursor protein cleavage. Alzheimers Res Ther. 2014 Nov 17;6(5-8):75. doi: 10.1186/s13195-014-0075-0. eCollection 2014.
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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 LY2811376 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 15 Jul 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Effects (time frame: Predose and up to Day 6 of each period). 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 NCT00838084, which also lists 1 linked publication.
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 15 Jul 2009.