HealthyPhase 1NCT03222427

A Study of LY3314814 in Healthy Participants

A Phase 1 study testing LY3314814 and [13C415N3] LY3314814 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.

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 measure how much LY3314814 gets into the bloodstream when it is given as a single dose by mouth and as an intravenous (IV) infusion over two hours. The study will last at least two weeks for each participant, not including screening. 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?: LY3314814 and [13C415N3] LY3314814
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited Kingdom
Study dates: 15 Jan 2018to 16 Feb 2018
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

Are overtly healthy males or females
Have venous access sufficient to allow for blood sampling and intravenous (IV) administration of the investigational product

Who cannot join

Have a history of significant ophthalmic disease
Have vitiligo or any other clinically significant disorder of skin pigmentation
Have a history of use of antipsychotic drugs, or chronic use of antidepressant or anxiolytic drugs, prescribed as well as non-prescribed

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Leeds, West Yorkshire

Other trials in United Kingdom

About this study

Official title: An Absolute Bioavailability Study of LY3314814 in Healthy Subjects Using an Intravenous Tracer Method

Conditions: Healthy
Being tested: LY3314814, [13C415N3] LY3314814

What participants receive

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

LY3314814Drug
Administered orally
[13C415N3] LY3314814Drug
Administered as an IV infusion

Study groups in NCT03222427
Study group	Role	What they receive
LY3314814	Experimental	Single 50 milligram (mg) dose of LY3314814 administered orally Receives: Drug: LY3314814
[13C415N3] LY3314814	Experimental	Single 100 micrograms (μg) intravenous (IV) dose of [13C415N3] LY3314814 administered as an IV infusion. Receives: Drug: [13C415N3] LY3314814

What is being measured

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

Absolute Bioavailability of LY3314814
Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered [13C415N3]-LY3314814.
Measured: Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose

Secondary outcomes (1)

Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814
Pharmacokinetics: Area Under the Drug Concentration-Time Curve from Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814
Measured: Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 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.

15 Jan 201816 Feb 2018

First posted19 Jul 2017
Study start15 Jan 2018
Primary completion16 Feb 2018
Study completion16 Feb 2018

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: Parallel groups
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03222427
Sponsor's protocol ID: 15993
Other IDs: I8D-MC-AZEP, 2017-001181-18, 2017
Status last verified: Oct 2019
First submitted: 18 Jul 2017
Last updated: 31 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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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Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Absolute Bioavailability Study of LY3314814 in Healthy Subjects Using an Intravenous Tracer Method
ClinicalTrials.gov ID: NCT03222427
Acronym / sponsor ID: 15993
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 15 Jan 2018 (actual)
Primary completion: 16 Feb 2018 (actual)
Study completion: 16 Feb 2018 (actual)
First posted: 19 Jul 2017 (actual)
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LY3314814	Experimental	Drug: LY3314814Single 50 milligram (mg) dose of LY3314814 administered orally
[13C415N3] LY3314814	Experimental	Drug: [13C415N3] LY3314814Single 100 micrograms (μg) intravenous (IV) dose of [13C415N3] LY3314814 administered as an IV infusion.

Who may qualify

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

Key inclusion criteria (2 listed)

Are overtly healthy males or females
Have venous access sufficient to allow for blood sampling and intravenous (IV) administration of the investigational product

Key exclusion criteria (3 listed)

Have a history of significant ophthalmic disease
Have vitiligo or any other clinically significant disorder of skin pigmentation
Have a history of use of antipsychotic drugs, or chronic use of antidepressant or anxiolytic drugs, prescribed as well as non-prescribed

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
LY3314814Administered orally	Drug	LY3314814
[13C415N3] LY3314814Administered as an IV infusion	Drug	[13C415N3] LY3314814

Primary outcome

Absolute Bioavailability of LY3314814
Time frame: Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose
Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered [13C415N3]-LY3314814.

1 secondary outcome

Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814
Time frame: Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 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
LY3314814 + [13C415N3] LY3314814	8	8

Primary outcome: Absolute Bioavailability of LY3314814

Time frame: Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter per mg

Measure	LY3314814 n = 8	[13C415N3] LY3314814 n = 7
Value	60.5 (41)	59.2 (17)

LY3314814 vs [13C415N3] LY3314814: Ratio of Geometric Least Squares Means: 0.952 (90% CI 0.769 to 1.18)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From baseline to end of study (Up To 7 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY3314814 + [13C415N3] LY3314814	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
CSPLink provided by the sponsor.
SAPLink provided by the sponsor.
CSPLink provided by the sponsor.
SAPLink provided by the sponsor.

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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 LY3314814 and [13C415N3] LY3314814 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.

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 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 31 Oct 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 Kingdom. 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 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?

Absolute Bioavailability of LY3314814 (time frame: Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose). 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 NCT03222427.

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 31 Oct 2019.