HealthyPhase 1NCT02540668

A Drug Interaction Study of Lanabecestat (LY3314814) and Warfarin in Healthy Participants

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

The purpose of this study is to look at how much warfarin gets into the blood stream and how long it takes the body to get rid of it when given both with and without lanabecestat. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Lanabecestat and Warfarin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 30 Sep 2015to 31 Jan 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 65 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

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
Have a history or presence of significant bleeding disorders
Have a history of gastrointestinal ulcers with hemorrhage
Have a personal or family history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations
Self-reported history of increased bleeding from trauma

Show all 12Show fewer

Have a history of major head trauma (with loss of consciousness) within the past year or minor head trauma (without loss of consciousness) within the last 3 months prior to screening
History of major surgery within 3 months of screening
Planned surgery within 14 days after the last day of dosing
International Normalized Ratio (INR)/ Prothrombin Time (PT) or activated partial thromboplastin time above the normal reference range at screening
Abnormal Protein S antigen and/or Protein C activity as determined by the investigator
History of deep vein thrombosis and/or pulmonary embolism

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Clinical Research Inc
Evansville, Indiana, 47710

Other trials in United States

About this study

Official title: Effect of LY3314814 on the Pharmacokinetics of Warfarin in Healthy Subjects

The purpose of this study is to look at how much warfarin gets into the blood stream and how long it takes the body to get rid of it when given both with and without lanabecestat. Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots when given with lanabecestat by measuring international normalized ratio (INR). INR measures the time it takes for blood to clot and compares it to an average. Information about any side effects that may occur will also be collected. The study will last about 5 weeks from the first dose to follow-up for each participant.

Conditions: Healthy
Being tested: Lanabecestat, Warfarin

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
WarfarinDrug
Administered orally

Study groups in NCT02540668
Study group	Role	What they receive
Warfarin	Experimental	Single oral dose of 15 mg warfarin on Day 1. Receives: Drug: Warfarin
Lanabecestat + Warfarin	Experimental	Lanabecestat administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22. Receives: Drug: Lanabecestat; Drug: Warfarin

What is being measured

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

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin
Measured: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22
Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin
Measured: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22

Secondary outcomes (4)

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound R-Warfarin
Measured: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22
Pharmacokinetics (PK): Area Under The Concentration Curve 0-∞(AUC) of Unbound R-Warfarin
Measured: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96,120, and 144 hours after administration of warfarin on Days 1 and 22
Pharmacodynamics (PD): Area Under the International Normalized Ratio (INR) Versus Time Curve (AUCINR) of Warfarin
Measured: Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22
Pharmacodynamics (PD): Maximum Observed INR Response (INRmax) of Warfarin
Measured: Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22

Timeline

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

30 Sep 201531 Jan 2016

First posted4 Sep 2015 (estimated)
Study start30 Sep 2015
Primary completion31 Jan 2016
Study completion31 Jan 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: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02540668
Sponsor's protocol ID: 16008
Other IDs: I8D-MC-AZEO
Status last verified: Oct 2019
First submitted: 2 Sep 2015
Last updated: 4 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?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of LY3314814 on the Pharmacokinetics of Warfarin in Healthy Subjects
ClinicalTrials.gov ID: NCT02540668
Acronym / sponsor ID: 16008
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 30 Sep 2015 (actual)
Primary completion: 31 Jan 2016 (actual)
Study completion: 31 Jan 2016 (actual)
First posted: 4 Sep 2015 (estimated)
Results: Posted 25 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: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Warfarin	Experimental	Drug: WarfarinSingle oral dose of 15 mg warfarin on Day 1.
Lanabecestat + Warfarin	Experimental	Drug: Lanabecestat, Drug: WarfarinLanabecestat administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 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

Key exclusion criteria (12 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
Have a history or presence of significant bleeding disorders
Have a history of gastrointestinal ulcers with hemorrhage
Have a personal or family history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations

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 + Warfarin
WarfarinAdministered orally	Drug	Lanabecestat + Warfarin, Warfarin

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin
Time frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22
Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin
Time frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22

4 secondary outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound R-Warfarin
Time frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22
Pharmacokinetics (PK): Area Under The Concentration Curve 0-∞(AUC) of Unbound R-Warfarin
Time frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96,120, and 144 hours after administration of warfarin on Days 1 and 22
Pharmacodynamics (PD): Area Under the International Normalized Ratio (INR) Versus Time Curve (AUCINR) of Warfarin
Time frame: Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22
Pharmacodynamics (PD): Maximum Observed INR Response (INRmax) of Warfarin
Time frame: Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22

Results and safety

Results posted to the registry on 25 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
Warfarin	15	15
LY3314814 + Warfarin	0	0

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin

Time frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Warfarin n = 15	LY3314814 + Warfarin n = 15
Value	3.50 (12)	3.73 (14)

Population analysed: All participants who received at least one dose of study drug.

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin

Measure	Warfarin n = 15	LY3314814 + Warfarin n = 15
Value	108 (18)	123 (19)

Population analysed: All participants who received at least one dose of study drug.

4 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
Warfarin	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
LY3314814	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
LY3314814 + Warfarin	0 of 15 (0%)	1 of 15 (6.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 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

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 Lanabecestat and Warfarin in people with Healthy, run by AstraZeneca 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 2 inclusion and 12 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 4 Nov 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. 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 25 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 Unbound S-Warfarin (time frame: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22). The study lists 2 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 NCT02540668.

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 4 Nov 2019.