HealthyPhase 1NCT02663128

A Study of Lanabecestat (LY3314814) in Healthy Participants

A Phase 1 study testing Lanabecestat in people with Healthy, run by AstraZeneca.

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

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Lanabecestat
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: No sites listed yet
Study dates: 31 Jan 2016to 31 Mar 2016
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 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male participants: Will be sterile (including vasectomy) or agree to use an effective method of birth control and will not donate sperm during the study and for 3 months following the last dose of the investigational product
Female participants: Women not of childbearing potential due to surgical sterilization or confirmed by medical history or menopause
Are able to eat a high-fat, high-calorie meal within the defined time limit and abide by the food restrictions throughout the study

Who cannot join

Have a history of or current, significant ophthalmic disease, as determined by the investigator or ophthalmologist
Have vitiligo or any other clinically significant disorder of skin pigmentation as determined by the investigator or dermatologist
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
History of previous or ongoing psychiatric disease/condition
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study, or have a history of significant dysrhythmias or atrioventricular (AV) block (including first degree AV block). Participants with history of persistent PR interval greater than (>)200 milliseconds (msec) will be excluded
Have prolonged Fridericia-corrected QT interval (QTcF) of >470 msec

Show all 10Show fewer

Have a clinically significant abnormal blood pressure or heart rate (supine) as determined by the investigator
Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
Are unwilling to comply with the dietary requirements/restrictions during the study
Evidence of active renal disease (e.g, diabetic renal disease, polycystic kidney disease) or calculated creatinine clearance <50 milliliters per minute (mL/min)

About this study

Official title: A Bioequivalence and Food Effect Study in Healthy Subjects Administered 2 Different Tablet Formulations of LY3314814

The purpose of this study is to measure how much of a new tablet formulation of lanabecestat gets into the blood stream and how long it takes the body to get rid of it, compared to the current tablet formulation of lanabecestat. The effect of a high fat meal on how quickly the body absorbs the new tablet formulation will also be evaluated. In addition any side effects of the study drug using both the new and current tablet formulations will be evaluated. The study will last about 22 days, with screening required within 30 days prior to the start of the study.

Conditions: Healthy
Being tested: Lanabecestat

What participants receive

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

LanabecestatDrug
Also called LY3314814, AZD3293
Administered orally

Study groups in NCT02663128
Study group	Role	What they receive
Lanabecestat Reference Fasted	Experimental	Lanabecestat: 50 mg administered once PO in each of 3 treatment periods. Receives: Drug: Lanabecestat
Lanabecestat Test Fasted	Experimental	Lanabecestat: 50 mg administered once PO in each of 3 treatment periods. Receives: Drug: Lanabecestat
Lanabecestat Test Non Fasted	Experimental	Lanabecestat: 50 mg administered once PO in each of 3 treatment periods. Receives: Drug: Lanabecestat

What is being measured

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

Pharmacokinetics(PK): Maximum Concentration (Cmax) of LY3314814 (AZD3293)
Measured: Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of LY3314814 (AZD3293)
Measured: Day 1 of Periods 1, 2, and 3:Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3314814 (AZD3293)
Measured: Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose

Timeline

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

31 Jan 201631 Mar 2016

First posted26 Jan 2016 (estimated)
Study start31 Jan 2016
Primary completion31 Mar 2016
Study completion31 Mar 2016

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 HealthyStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02663128
Sponsor's protocol ID: 16001
Other IDs: I8D-MC-AZEH
Status last verified: Oct 2019
First submitted: 21 Jan 2016
Last updated: 1 Nov 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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Bioequivalence and Food Effect Study in Healthy Subjects Administered 2 Different Tablet Formulations of LY3314814
ClinicalTrials.gov ID: NCT02663128
Acronym / sponsor ID: 16001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 31 Jan 2016 (actual)
Primary completion: 31 Mar 2016 (actual)
Study completion: 31 Mar 2016 (actual)
First posted: 26 Jan 2016 (estimated)
Results: Posted 22 Mar 2019

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Lanabecestat Reference Fasted	Experimental	Drug: LanabecestatLanabecestat: 50 mg administered once PO in each of 3 treatment periods.
Lanabecestat Test Fasted	Experimental	Drug: LanabecestatLanabecestat: 50 mg administered once PO in each of 3 treatment periods.
Lanabecestat Test Non Fasted	Experimental	Drug: LanabecestatLanabecestat: 50 mg administered once PO in each of 3 treatment periods.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male participants: Will be sterile (including vasectomy) or agree to use an effective method of birth control and will not donate sperm during the study and for 3 months following the last dose of the investigational product
Female participants: Women not of childbearing potential due to surgical sterilization or confirmed by medical history or menopause
Are able to eat a high-fat, high-calorie meal within the defined time limit and abide by the food restrictions throughout the study

Key exclusion criteria (10 listed)

Have a history of or current, significant ophthalmic disease, as determined by the investigator or ophthalmologist
Have vitiligo or any other clinically significant disorder of skin pigmentation as determined by the investigator or dermatologist
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
History of previous or ongoing psychiatric disease/condition
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study, or have a history of significant dysrhythmias or atrioventricular (AV) block (including first degree AV block). Participants with history of persistent PR interval greater than (>)200 milliseconds (msec) will be excluded

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
LanabecestatAlso: LY3314814, AZD3293Administered orally	Drug	Lanabecestat Reference Fasted, Lanabecestat Test Fasted, Lanabecestat Test Non Fasted

Primary outcome

Pharmacokinetics(PK): Maximum Concentration (Cmax) of LY3314814 (AZD3293)
Time frame: Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of LY3314814 (AZD3293)
Time frame: Day 1 of Periods 1, 2, and 3:Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3314814 (AZD3293)
Time frame: Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose

Results and safety

Results posted to the registry on 22 Mar 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
Sequence 1	3	3
Sequence 2	3	3
Sequence 3	3	3
Sequence 4	3	3
Sequence 5	3	3
Sequence 6	3	3

Primary outcome: Pharmacokinetics(PK): Maximum Concentration (Cmax) of LY3314814 (AZD3293)

Time frame: Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	R (Fasted) n = 18	T (Fasted) n = 17	T (Fed) n = 18
18 to 55 Years	194 (22)	212 (22)	164 (21)
> 55 Years	208 (31)	196 (36)	168 (32)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

Primary outcome: PK: Time of Maximum Observed Drug Concentration (Tmax) of LY3314814 (AZD3293)

Time frame: Day 1 of Periods 1, 2, and 3:Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose. Median (Full Range). Unit: Hour (h)

Measure	R (Fasted) n = 18	T (Fasted) n = 17	T (Fed) n = 18
18 to 55 Years	2.00 (1.00 to 4.00)	1.50 (1.00 to 3.02)	4.01 (1.50 to 8.00)
> 55 Years	2.26 (1.00 to 4.12)	1.50 (1.00 to 4.00)	3.50 (1.50 to 6.00)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

Primary outcome: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3314814 (AZD3293)

Measure	R (Fasted) n = 18	T (Fasted) n = 17	T (Fed) n = 18
18 to 55 Years	2920 (12)	2850 (13)	2970 (9)
> 55 Years	3040 (16)	3020 (27)	2820 (23)

Population analysed: All participants who received at least one dose of study drug and had evaluable PK data.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
R (Fasted)	0 of 18 (0%)	5 of 18 (27.8%)	Not reported
T (Fasted)	0 of 17 (0%)	4 of 17 (23.5%)	Not reported
T (Fed)	0 of 18 (0%)	4 of 18 (22.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lanabecestat in people with Healthy, run by AstraZeneca.

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 10 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 22 Mar 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?

Pharmacokinetics(PK): Maximum Concentration (Cmax) of LY3314814 (AZD3293) (time frame: Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose). The study lists 3 primary outcomes in all. 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 NCT02663128.

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 1 Nov 2019.