HealthyPhase 1NCT02906618

Study of LY3039478 in Healthy Participants

A Phase 1 study testing LY3039478 and 13C 15N 2H-LY3039478 IV in people with Healthy, run by Eli Lilly and Company 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

Search all trials

Trial summary

The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this study will help to answer the following research questions: How much LY3039478 gets into the blood stream when given by mouth as a capsule… 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?: LY3039478 and 13C 15N 2H-LY3039478 IV
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited Kingdom
Study dates: 4 Oct 2016to 11 Nov 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

Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²) inclusive

Who cannot join

Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product
Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy in the opinion of the investigator

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

Other trials in United Kingdom

About this study

Official title: An Absolute Bioavailability Study of LY3039478 in Healthy Subjects Using the Intravenous Tracer Method

How much LY3039478 gets into the blood stream when given by mouth as a capsule compared to when given by an IV
How long it takes the body to remove the study drug
The safety of LY3039478 and any side effects that might be associated with it

Participation in the study is expected to last up to 7 weeks. There will be screening, a single study period, and a follow-up.

Conditions: Healthy
Being tested: LY3039478, 13C 15N 2H-LY3039478 IV

What participants receive

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

LY3039478Drug
Administered orally
13C 15N 2H-LY3039478 IVDrug
Administered IV

Study groups in NCT02906618
Study group	Role	What they receive
LY3039478 - Oral	Experimental	LY3039478 given once, orally Receives: Drug: LY3039478
13C 15N 2H-LY3039478 - IV	Experimental	13C 15N 2H-LY3039478 given once, IV Receives: Drug: 13C 15N 2H-LY3039478 IV

What is being measured

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

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478
Pharmacokinetics (PK) is the area under the concentration versus time curve (AUC) from time zero to the last time point with a measurable concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose
PK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY3039478
PK is AUC from zero to infinity (AUC[0 - inf]) of LY3039478 and 13C 15N 2H-LY3039478.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose

Secondary outcomes (3)

PK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IV
PK is the maximum observed drug concentration (cmax) of LY3039478 13C 15N 2H-LY3039478 - IV.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose
PK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY3039478
PK is the time of Cmax (tmax) of LY3039478 and 13C 15N 2H-LY3039478.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose
PK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478
PK is the half life associated with the terminal rate constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478.
Measured: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose

Timeline

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

4 Oct 201611 Nov 2016

First posted20 Sep 2016 (estimated)
Study start4 Oct 2016
Primary completion11 Nov 2016
Study completion11 Nov 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 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02906618
Sponsor's protocol ID: 16344
Other IDs: I6F-MC-JJCG, 2016-001073-33, 2016
Status last verified: Jun 2025
First submitted: 15 Sep 2016
Last updated: 9 Jul 2025
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

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Absolute Bioavailability Study of LY3039478 in Healthy Subjects Using the Intravenous Tracer Method
ClinicalTrials.gov ID: NCT02906618
Acronym / sponsor ID: 16344
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 4 Oct 2016
Primary completion: 11 Nov 2016 (actual)
Study completion: 11 Nov 2016 (actual)
First posted: 20 Sep 2016 (estimated)
Results: Posted 9 Jul 2025

Clinical summary

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

How much LY3039478 gets into the blood stream when given by mouth as a capsule compared to when given by an IV
How long it takes the body to remove the study drug
The safety of LY3039478 and any side effects that might be associated with it

Participation in the study is expected to last up to 7 weeks. There will be screening, a single study period, and a follow-up.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LY3039478 - Oral	Experimental	Drug: LY3039478LY3039478 given once, orally
13C 15N 2H-LY3039478 - IV	Experimental	Drug: 13C 15N 2H-LY3039478 IV13C 15N 2H-LY3039478 given once, IV

Who may qualify

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

Key inclusion criteria (1 listed)

Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²) inclusive

Key exclusion criteria (2 listed)

Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product
Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy in the opinion of the investigator

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
LY3039478Administered orally	Drug	LY3039478 - Oral
13C 15N 2H-LY3039478 IVAdministered IV	Drug	13C 15N 2H-LY3039478 - IV

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose
Pharmacokinetics (PK) is the area under the concentration versus time curve (AUC) from time zero to the last time point with a measurable concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478.
PK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY3039478
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose
PK is AUC from zero to infinity (AUC[0 - inf]) of LY3039478 and 13C 15N 2H-LY3039478.

3 secondary outcomes

PK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IV
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose
PK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY3039478
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose
PK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478
Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose

Results and safety

Results posted to the registry on 9 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY3039478 - Oral and 13C 15N 2H-LY3039478 - IV	12	12

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478

Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nangogram*hour/milliliter (ng*h/mL)

Measure	LY3039478 - Oral n = 12	13C 15N 2H-LY3039478 - IV n = 12
Value	1920 (23)	15.6 (16)

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

Primary outcome: PK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY3039478

Time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	LY3039478 - Oral n = 12	13C 15N 2H-LY3039478 - IV n = 12
Value	1920 (23)	15.6 (16)

LY3039478 - Oral vs 13C 15N 2H-LY3039478 - IV: Ratio of geometric LS means: 0.572 (90% CI 0.532 to 0.615)

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

3 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
LY3039478 - Oral and 13C 15N 2H-LY3039478 - IV	0 of 12 (0%)	2 of 12 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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 LY3039478 and 13C 15N 2H-LY3039478 IV in people with Healthy, run by Eli Lilly and Company 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 1 inclusion and 2 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 9 Jul 2025. 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 9 Jul 2025). 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): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478 (time frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 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 NCT02906618.

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 9 Jul 2025.