HealthyPhase 1NCT02385084

A Study of LY2409021 Formulations in Healthy Participants

A Phase 1 study testing LY2409021 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LY2409021
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Mar 2015to May 2015
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 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Overtly healthy males or surgically sterile or postmenopausal females, as determined by medical history and physical examination
Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m^2)
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

Who cannot join

Have known allergies to LY2409021, related compounds or any components of the formulation, or history of significant atopy
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have known or ongoing psychiatric disorders

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance CRU, Inc
Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: A Single Dose Pharmacokinetic Study of LY2409021 in Healthy Subjects to Bridge Formulations From Capsules to Commercial Tablets

The purpose of this study is to measure how much of the new LY2409021 tablet formulations get into the blood stream and how long it takes the body to get rid of them, compared to the current LY2409021 capsule formulation. In addition, the safety and tolerability of both the new and current formulations will be evaluated. Information about any side effects that may occur will also be collected. The study has two parts. Each participant may enroll in one part only. The study will last up to 8 weeks for each participant. Screening is required prior to the start of the study.

Conditions: Healthy
Being tested: LY2409021

What participants receive

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

LY2409021Drug
Administered orally

Study groups in NCT02385084
Study group	Role	What they receive
Part A: LY2409021 Capsule	Experimental	Single oral dose of LY2409021 capsule in one of three study periods. Receives: Drug: LY2409021
Part A: LY2409021 Tablet Pre-commercial	Experimental	Single oral dose of LY2409021 tablet (pre-commercial formulation) in one of three study periods. Receives: Drug: LY2409021
Part A: LY2409021 Tablet Commercial	Experimental	Single oral dose of LY2409021 tablet (commercial formulation) in one of three study periods. Receives: Drug: LY2409021
Part B: LY2409021 Capsule	Experimental	Single oral dose of LY2409021 capsule in one of two study periods. Receives: Drug: LY2409021
Part B: LY2409021 Tablet Commercial	Experimental	Single oral dose of LY2409021 tablet (commercial formulation) in one of two study periods. Receives: Drug: LY2409021

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 From Zero to Infinity (AUC[0-inf]) of LY2409021
Measured: Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period
PK: Maximum Plasma Concentration (Cmax) of LY2409021
Measured: Day 1: Predose, 0.5 H, 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period

Timeline

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

Mar 2015May 2015

First posted11 Mar 2015 (estimated)
Study startMar 2015
Primary completionMay 2015
Study completionMay 2015

Why it stopped: Part B of the study no longer required due to new information on the study drug.

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: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02385084
Sponsor's protocol ID: 15709
Other IDs: I1R-MC-GLDM
Status last verified: Mar 2018
First submitted: 5 Mar 2015
Last updated: 29 Oct 2018
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 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose Pharmacokinetic Study of LY2409021 in Healthy Subjects to Bridge Formulations From Capsules to Commercial Tablets
ClinicalTrials.gov ID: NCT02385084
Acronym / sponsor ID: 15709
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Part B of the study no longer required due to new information on the study drug.
Enrolment: 18 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2015
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 11 Mar 2015 (estimated)
Results: Posted 29 Oct 2018

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: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Part A: LY2409021 Capsule	Experimental	Drug: LY2409021Single oral dose of LY2409021 capsule in one of three study periods.
Part A: LY2409021 Tablet Pre-commercial	Experimental	Drug: LY2409021Single oral dose of LY2409021 tablet (pre-commercial formulation) in one of three study periods.
Part A: LY2409021 Tablet Commercial	Experimental	Drug: LY2409021Single oral dose of LY2409021 tablet (commercial formulation) in one of three study periods.
Part B: LY2409021 Capsule	Experimental	Drug: LY2409021Single oral dose of LY2409021 capsule in one of two study periods.
Part B: LY2409021 Tablet Commercial	Experimental	Drug: LY2409021Single oral dose of LY2409021 tablet (commercial formulation) in one of two study periods.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Overtly healthy males or surgically sterile or postmenopausal females, as determined by medical history and physical examination
Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m^2)
Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

Key exclusion criteria (3 listed)

Have known allergies to LY2409021, related compounds or any components of the formulation, or history of significant atopy
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have known or ongoing psychiatric disorders

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
LY2409021Administered orally	Drug	Part A: LY2409021 Capsule, Part A: LY2409021 Tablet Commercial, Part A: LY2409021 Tablet Pre-commercial, Part B: LY2409021 Capsule, Part B: LY2409021 Tablet Commercial

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2409021
Time frame: Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period
PK: Maximum Plasma Concentration (Cmax) of LY2409021
Time frame: Day 1: Predose, 0.5 H, 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period

Results and safety

Results posted to the registry on 29 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2409021 Capsules/T2/T3 (Part A)	3	3
LY2409021 T2/Capsules/T3 (Part A)	3	3
LY2409021 T3/T2/Capsules (Part A)	3	3
LY2409021 T3/Capsules/T2 (Part A)	3	3
LY2409021 T2/T3/Capsules (Part A)	3	3
LY2409021 Capsules/T3/T2 (Part A)	3	3

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2409021

Time frame: Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms x hours/milliliters (ng•h/mL

Measure	LY2409021 Capsules (Part A) n = 14	LY2409021 T2 (Part A) n = 17	LY2409021 T3 (Part A) n = 17
Value	56400 (17)	55700 (24)	59100 (15)

Population analysed: All participants who received the LY2409021 formulation and had evaluable AUC(0-inf) values. PK data for 1 participant who met study exclusion criteria was excluded from analyses. This participant only received the capsule formulation.

Primary outcome: PK: Maximum Plasma Concentration (Cmax) of LY2409021

Time frame: Day 1: Predose, 0.5 H, 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	LY2409021 Capsules (Part A) n = 14	LY2409021 T2 (Part A) n = 17	LY2409021 T3 (Part A) n = 17
Value	724 (18)	718 (30)	760 (20)

Population analysed: All participants who received the LY2409021 formulation and had evaluable Cmax values. PK data for 1 participant who met study exclusion criteria was excluded from analyses. This participant only received the capsule formulation.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY2409021 Capsules (Part A)	0 of 15 (0%)	4 of 15 (26.7%)	Not reported
LY2409021 T2 (Part A)	0 of 17 (0%)	1 of 17 (5.9%)	Not reported
LY2409021 T3 (Part A)	0 of 17 (0%)	4 of 17 (23.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
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 LY2409021 in people with Healthy, run by Eli Lilly and Company 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 3 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: stopped early, as of the sponsor's last update on 29 Oct 2018. 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 29 Oct 2018). 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 From Zero to Infinity (AUC[0-inf]) of LY2409021 (time frame: Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period). 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 NCT02385084.

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 29 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.