HealthyPhase 1NCT02659865

A Study of LY3039478 in Healthy Participants

A Phase 1 study testing LY3039478 Capsule Formulation (Formulation 3), LY3039478 Drug-in Capsule (Reference, Formulation 1) and LY3039478 Formulated Capsule (Test, Formulation 3) in people with Healthy, run by Eli Lilly and Company 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 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LY3039478 Capsule Formulation (Formulation 3), LY3039478 Drug-in Capsule (Reference, Formulation 1) and LY3039478 Formulated Capsule (Test, Formulation 3)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 29 participants
Where: 1 siteUnited States
Study dates: Jan 2016to Jun 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

Body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m²)

Who cannot join

Known allergies to LY3039478, related compounds or any components of the formulation
Have previously received LY3039478
Smokers or who have stopped smoking less than 3 months prior to enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance
Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: A Single Ascending Dose Study for the Evaluation of the Effects of LY3039478 on the QT/Corrected QT Interval in Healthy Subjects and Pilot Relative Bioavailability

The main purpose of this study is to investigate the safety of the study drug known as LY3039478 and evaluate two different formulations of LY3039478 in healthy participants. Part A has three periods. Either LY3039478 or placebo will be given once by mouth in each period. Part B has two periods. Participants will receive both formulations of LY3039478, by mouth, over the course of the study. Both parts of the study will also explore how much LY3039478 gets into the bloodstream and how long it takes the body to get rid of it. Information about any side effects will also be collected. Participants may only enroll in one part. The study will last at least 33 days, not including screening. Screening must be performed up to 30 days before enrollment.

Part B was added by protocol amendment approved in April, 2016.

Conditions: Healthy
Being tested: Placebo, LY3039478 Capsule Formulation (Formulation 3), LY3039478 Drug-in Capsule (Reference, Formulation 1), LY3039478 Formulated Capsule (Test, Formulation 3)

What participants receive

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

PlaceboDrug
Administered orally
LY3039478 Capsule Formulation (Formulation 3)Drug
Also called New Formulation
Administered orally
LY3039478 Drug-in Capsule (Reference, Formulation 1)Drug
Also called Original Formulation
Administered orally
LY3039478 Formulated Capsule (Test, Formulation 3)Drug
Also called New Formulation
Administered orally

Study groups in NCT02659865
Study group	Role	What they receive
Part A: Placebo	Placebo comparator	Single oral dose of placebo administered in one of three study periods Receives: Drug: Placebo
Part A: LY3039478 Capsule Formulation (Formulation 3)	Experimental	Escalating single oral dose of 25 milligram (mg), 50 mg, and 75 mg capsule formulation (formulation 3) LY3039478 administered in two of three study periods Receives: Drug: LY3039478 Capsule Formulation (Formulation 3)
Part B: LY3039478 Drug-In Capsule (Reference, Formulation 1)	Experimental	Single oral 50 mg dose of drug-in capsule (reference, formulation 1) LY3039478 administered in one of two study periods Receives: Drug: LY3039478 Drug-in Capsule (Reference, Formulation 1)
Part B: LY3039478 Formulated Capsule (Test, Formulation 3)	Experimental	Single oral 50 mg dose of formulated capsule (test, formulation 3) LY3039478 administered in one of two study periods Receives: Drug: LY3039478 Formulated Capsule (Test, Formulation 3)

What is being measured

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

Pharmacokinetics (PK): Mean Time-Matched Difference in Placebo-Adjusted QTcF Interval With Time Matched Concentrations Between LY3039478 Capsule Formulation (Formulation 3) Part A
PK: mean time-matched difference in QTcF interval with time-matched concentrations between LY3039478 capsule formulation (formulation 3) compared to placebo. Analyses of QTcF was assessed by the mean change in QTcF as a function of plasma drug concentration. Triplicate measures at each time point was averaged prior to analysis. The primary analysis was based on the time-matched placebo-adjusted QTcF (ΔQTcF) for each time point, which was calculated by subtracting each participant's time-matched placebo QTcF from their QTcF results after receiving LY3039478. The relationship between plasma concentrations of LY3039478 and ΔQTcF was evaluated using a linear mixed-effects modeling approach. The response variable was ΔQTcF, and concentrations was fitted as a fixed effect with participants as a random effect. The regression slope was presented with the unit in "milliseconds per nanogram per milliliter" abbreviated as "ms/ng/mL".
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose

Secondary outcomes (4)

PK: Cmax of LY3039478 Capsule Formulation (Formulation 3) Part A
PK is Cmax of LY3039478 capsule formulation (formulation 3) in part A.
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3039478 Capsule Formulation (Formulation 3) Part A
PK is the area under the concentration versus time curve from zero to infinity (AUC[0-∞]) of LY3039478 capsule formulation (formulation 3) in part A.
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose
PK: Cmax of the 2 Formulations of LY3039478 Part B
PK is the Cmax of the 2 formulations of LY3039478 in part B
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose
PK: AUC(0-∞) of the 2 Formulations of LY3039478 Part B
PK is the AUC(0-∞) of the 2 formulations of LY3039478 in part B.
Measured: Predose, 0.5, 1, 2, 3, 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.

Jan 2016Jun 2016

First posted20 Jan 2016 (estimated)
Study startJan 2016
Primary completionJun 2016
Study completionJun 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: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02659865
Sponsor's protocol ID: 16263
Other IDs: I6F-MC-JJCE
Status last verified: Jul 2025
First submitted: 18 Jan 2016
Last updated: 12 Aug 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

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Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Ascending Dose Study for the Evaluation of the Effects of LY3039478 on the QT/Corrected QT Interval in Healthy Subjects and Pilot Relative Bioavailability
ClinicalTrials.gov ID: NCT02659865
Acronym / sponsor ID: 16263
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jan 2016
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 20 Jan 2016 (estimated)
Results: Posted 12 Aug 2025

Clinical summary

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

Part B was added by protocol amendment approved in April, 2016.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Part A: Placebo	Placebo comparator	Drug: PlaceboSingle oral dose of placebo administered in one of three study periods
Part A: LY3039478 Capsule Formulation (Formulation 3)	Experimental	Drug: LY3039478 Capsule Formulation (Formulation 3)Escalating single oral dose of 25 milligram (mg), 50 mg, and 75 mg capsule formulation (formulation 3) LY3039478 administered in two of three study periods
Part B: LY3039478 Drug-In Capsule (Reference, Formulation 1)	Experimental	Drug: LY3039478 Drug-in Capsule (Reference, Formulation 1)Single oral 50 mg dose of drug-in capsule (reference, formulation 1) LY3039478 administered in one of two study periods
Part B: LY3039478 Formulated Capsule (Test, Formulation 3)	Experimental	Drug: LY3039478 Formulated Capsule (Test, Formulation 3)Single oral 50 mg dose of formulated capsule (test, formulation 3) LY3039478 administered in one of two study periods

Who may qualify

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

Key inclusion criteria (1 listed)

Body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m²)

Key exclusion criteria (3 listed)

Known allergies to LY3039478, related compounds or any components of the formulation
Have previously received LY3039478
Smokers or who have stopped smoking less than 3 months prior to enrollment

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
PlaceboAdministered orally	Drug	Part A: Placebo
LY3039478 Capsule Formulation (Formulation 3)Also: New FormulationAdministered orally	Drug	Part A: LY3039478 Capsule Formulation (Formulation 3)
LY3039478 Drug-in Capsule (Reference, Formulation 1)Also: Original FormulationAdministered orally	Drug	Part B: LY3039478 Drug-In Capsule (Reference, Formulation 1)
LY3039478 Formulated Capsule (Test, Formulation 3)Also: New FormulationAdministered orally	Drug	Part B: LY3039478 Formulated Capsule (Test, Formulation 3)

Primary outcome

Pharmacokinetics (PK): Mean Time-Matched Difference in Placebo-Adjusted QTcF Interval With Time Matched Concentrations Between LY3039478 Capsule Formulation (Formulation 3) Part A
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose
PK: mean time-matched difference in QTcF interval with time-matched concentrations between LY3039478 capsule formulation (formulation 3) compared to placebo. Analyses of QTcF was assessed by the mean change in QTcF as a function of plasma drug concentration. Triplicate measures at each time point was averaged prior to analysis. The primary analysis was based on the time-matched placebo-adjusted QTcF (ΔQTcF) for each time point, which was calculated by subtracting each participant's time-matched placebo QTcF from their QTcF results after receiving LY3039478. The relationship between plasma concentrations of LY3039478 and ΔQTcF was evaluated using a linear mixed-effects modeling approach. The response variable was ΔQTcF, and concentrations was fitted as a fixed effect with participants as a random effect. The regression slope was presented with the unit in "milliseconds per nanogram per milliliter" abbreviated as "ms/ng/mL".

4 secondary outcomes

PK: Cmax of LY3039478 Capsule Formulation (Formulation 3) Part A
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3039478 Capsule Formulation (Formulation 3) Part A
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose
PK: Cmax of the 2 Formulations of LY3039478 Part B
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose
PK: AUC(0-∞) of the 2 Formulations of LY3039478 Part B
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose

Results and safety

Results posted to the registry on 12 Aug 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
Part A: Group 1 (25 mg LY3039478 First, Then 50 mg LY3039478, Followed by Placebo)	5	4
Part A: Group 2 (25 mg LY3039478 First, Then Placebo, Followed by 75 mg LY3039478)	5	5
Part A: Group 3 (Placebo First, Then 50 mg LY3039478, Followed by 75 mg LY3039478)	5	5
Part B: 50 mg LY3039478 (Reference Formulation 1 First, Then Test Formulation 3)	7	7
Part B: 50 mg LY3039478 (Test Formulation 3 First, Then Reference Formulation 1)	7	6

Primary outcome: Pharmacokinetics (PK): Mean Time-Matched Difference in Placebo-Adjusted QTcF Interval With Time Matched Concentrations Between LY3039478 Capsule Formulation (Formulation 3) Part A

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose. Mean (90% Confidence Interval). Unit: ms/ng/mL

Measure	Part A: LY3039478 Capsule Formulation (Formulation 3)+Placebo n = 15
Value	-0.001 (-0.006 to 0.003)

Population analysed: All randomized participants who received at least one dose of study drug and had evaluable mean time-matched difference in QTcF interval data in part A. Data from all dose levels were combined due to analysis is looking at QTcF as a function of concentration of LY in the blood, not as a function of dose per protocol and statistical analysis plan.

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
Part A: Placebo	0 of 14 (0%)	1 of 14 (7.1%)	Not reported
Part A: 25 mg of LY3039478 Capsule Formulation (Formulation 3)	0 of 10 (0%)	1 of 10 (10%)	Not reported
Part A: 50 mg of LY3039478 Capsule Formulation (Formulation 3)	0 of 9 (0%)	1 of 9 (11.1%)	Not reported
Part A: 75 mg of LY3039478 Capsule Formulation (Formulation 3)	0 of 10 (0%)	0 of 10 (0%)	Not reported
Part B: LY3039478 Reference, Formulation 1	0 of 13 (0%)	1 of 13 (7.7%)	Not reported
Part B: LY3039478 Test, Formulation 3	0 of 14 (0%)	1 of 14 (7.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
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?

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 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 12 Aug 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 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. Some participants in this study may receive a placebo. 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 12 Aug 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): Mean Time-Matched Difference in Placebo-Adjusted QTcF Interval With Time Matched Concentrations Between LY3039478 Capsule Formulation (Formulation 3) Part A (time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose). 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 NCT02659865.

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 12 Aug 2025.