HealthyPhase 1NCT02568397

A Drug-drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants

A Phase 1 study testing Lanabecestat and Dabigatran etexilate 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

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Lanabecestat and Dabigatran etexilate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 31 Oct 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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Overtly healthy males and females

Who cannot join

Eye abnormalities or disease
History of vitiligo or any skin color disorder
Have a history psychiatric or brain disease including seizures
Have smoked within the last 3 months
Are unwilling to avoid food and drinks containing grapefruit or Seville oranges for the duration of the study
Have known allergies to dabigatran etexilate and related compounds

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance
Dallas, Texas, 75247

Other trials in United States

About this study

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

The purpose of this study is to learn about the effect of lanabecestat on how the body absorbs and processes dabigatran etexilate and how dabigatran etexilate affects lanabecestat when they are taken together. This study will last about 28 days and participants will be asked to take an lanabecestat tablet daily for 19 days and a dabigatran etexilate tablet on 3 occasions. Screening is required within 30 days prior to the start of the study.

Conditions: Healthy
Being tested: Lanabecestat, Dabigatran etexilate

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
Dabigatran etexilateDrug
Administered orally

Study groups in NCT02568397
Study group	Role	What they receive
Dabigatran Etexilate	Experimental	Single dose of dabigatran etexilate administered orally. Receives: Drug: Dabigatran etexilate
Lanabecestat and Dabigatran Etexilate	Experimental	Single dose of lanabecestat administered orally once daily on Days 3 to 21. Single doses of dabigatran etexilate administered orally on Days 16 and 20 during the lanabecestat dosing. Receives: Drug: Lanabecestat; Drug: Dabigatran etexilate

What is being measured

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

Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

Secondary outcomes (4)

Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose
Pharmacokinetics: Area Under the Lanabecestat Pharmacokinetic (PK) Concentration Versus Time Curve During One Dosing Interval (24 Hours) (AUCtau)
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose
Pharmacodynamics: Area Under the Effect Versus Time Curve (AUEC) of Thrombin Time
Measured: Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
Pharmacodynamics: Ratio of Maximum Effect to Baseline Effect (ERmax) of Thrombin Time
Ratio of maximum effect to baseline effect following administration of 150 mg dabigatran etexilate alone on Day 1, 50 mg LY3314814 and 150 mg dabigatran dosed concurrently on Day 16, and 50 mg LY3314814 and 150 mg dabigatran (dosed 4 hours later) on Day 20
Measured: Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

Timeline

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

31 Oct 201531 Jan 2016

First posted5 Oct 2015 (estimated)
Study start31 Oct 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: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02568397
Sponsor's protocol ID: 15997
Other IDs: I8D-MC-AZEE
Status last verified: Oct 2019
First submitted: 2 Oct 2015
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?

See locations

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All Healthy trials

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: Effect of LY3314814 on the Pharmacokinetics of Dabigatran in Healthy Subjects
ClinicalTrials.gov ID: NCT02568397
Acronym / sponsor ID: 15997
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 31 Oct 2015 (actual)
Primary completion: 31 Jan 2016 (actual)
Study completion: 31 Jan 2016 (actual)
First posted: 5 Oct 2015 (estimated)
Results: Posted 5 Apr 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: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dabigatran Etexilate	Experimental	Drug: Dabigatran etexilateSingle dose of dabigatran etexilate administered orally.
Lanabecestat and Dabigatran Etexilate	Experimental	Drug: Lanabecestat, Drug: Dabigatran etexilateSingle dose of lanabecestat administered orally once daily on Days 3 to 21. Single doses of dabigatran etexilate administered orally on Days 16 and 20 during the lanabecestat dosing.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Overtly healthy males and females

Key exclusion criteria (6 listed)

Eye abnormalities or disease
History of vitiligo or any skin color disorder
Have a history psychiatric or brain disease including seizures
Have smoked within the last 3 months
Are unwilling to avoid food and drinks containing grapefruit or Seville oranges for the duration of the study

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 and Dabigatran Etexilate
Dabigatran etexilateAdministered orally	Drug	Dabigatran Etexilate, Lanabecestat and Dabigatran Etexilate

Primary outcome

Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

4 secondary outcomes

Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose
Pharmacokinetics: Area Under the Lanabecestat Pharmacokinetic (PK) Concentration Versus Time Curve During One Dosing Interval (24 Hours) (AUCtau)
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose
Pharmacodynamics: Area Under the Effect Versus Time Curve (AUEC) of Thrombin Time
Time frame: Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose
Pharmacodynamics: Ratio of Maximum Effect to Baseline Effect (ERmax) of Thrombin Time
Time frame: Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose

Results and safety

Results posted to the registry on 5 Apr 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
Dabigatran Etexilate	60	60
LY3314814 + Dabigatran Etexilate	0	0

Primary outcome: Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Dabigatran Etexilate n = 60	LY3314814 and Dabigatran Etexilate Day 16 n = 56	LY3314814 and Dabigatran Etexilate Day 20 n = 54
Value	128 (69)	148 (56)	138 (46)

Population analysed: All participants who received at least one dose of study drug and have evaluable pharmacokinetic (PK) data.

Primary outcome: Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity)

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*h/mL)

Measure	Dabigatran Etexilate n = 60	LY3314814 and Dabigatran Etexilate Day 16 n = 56	LY3314814 and Dabigatran Etexilate Day 20 n = 54
Value	1090 (61)	1240 (53)	1110 (44)

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

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran Etexilate	0 of 60 (0%)	3 of 60 (5%)	Not reported
LY3314814 (AZD3293)	0 of 60 (0%)	8 of 60 (13.3%)	Not reported
LY3314814 and Dabigatran Etexilate Day 16	0 of 58 (0%)	2 of 58 (3.4%)	Not reported
LY3314814 and Dabigatran Etexilate Day 20	0 of 58 (0%)	4 of 58 (6.9%)	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

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 Dabigatran etexilate 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 1 inclusion and 6 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.

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 5 Apr 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 Dabigatran (time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose). 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 NCT02568397.

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.