Healthy VolunteersPhase 1NCT02242981

A Study of How the Body Breaks Down and Eliminates LY2623091

A Phase 1 study testing LY2623091 in people with Healthy Volunteers, 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 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: LY2623091
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Sep 2014to Nov 2014
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
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Overtly healthy males; as determined by physical examination, clinical laboratory tests, medical history and electrocardiograms (ECGs).
With a body mass index of 18.5 to 32.0 kilogram per square meter (kg/m^2), inclusive.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: Disposition of [14C]-LY2623091 Following Oral Administration in Healthy Subjects

This type of study is called a radiolabeled study. For this study, LY2623091 (study drug) has been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally occurring radioactive form of the element, carbon. This study will increase understanding about how the drug appears in the blood, urine, and stool after it is administered to healthy participants. Information about any side effects that may occur will also be collected. This study will last up to 22 days for each participant, not including screening. Screening is required within 28 days prior to enrollment

Conditions: Healthy Volunteers
Being tested: LY2623091

What participants receive

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

LY2623091Drug
Administered orally

Study groups in NCT02242981
Study group	Role	What they receive
LY2623091	Experimental	Single oral dose of LY2623091 Receives: Drug: LY2623091

What is being measured

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

Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals.
Measured: Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours)

Secondary outcomes (4)

Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091
Measured: Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)
Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091
Measured: Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)
Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091
Measured: Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)
Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces
Measured: Day 1 (predose, 2, 3, 4, 6, 8, and 12 hours postdose), and at 24 and 48 hours postdose

Timeline

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

Sep 2014Nov 2014

First posted17 Sep 2014 (estimated)
Study startSep 2014
Primary completionNov 2014
Study completionNov 2014

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 Healthy VolunteersStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02242981
Sponsor's protocol ID: 15517
Other IDs: I7T-MC-RMAA
Status last verified: Jun 2020
First submitted: 16 Sep 2014
Last updated: 26 Jun 2020
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 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Disposition of [14C]-LY2623091 Following Oral Administration in Healthy Subjects
ClinicalTrials.gov ID: NCT02242981
Acronym / sponsor ID: 15517
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2014
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 17 Sep 2014 (estimated)
Results: Posted 26 Jun 2020

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LY2623091	Experimental	Drug: LY2623091Single oral dose of LY2623091

Who may qualify

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

Key inclusion criteria (2 listed)

Overtly healthy males; as determined by physical examination, clinical laboratory tests, medical history and electrocardiograms (ECGs).
With a body mass index of 18.5 to 32.0 kilogram per square meter (kg/m^2), inclusive.

Key exclusion criteria (0 listed)

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
LY2623091Administered orally	Drug	LY2623091

Primary outcome

Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Time frame: Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours)
Cumulative percent of radioactive dose recovered in urine and feces after administration at specified intervals.

4 secondary outcomes

Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091
Time frame: Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)
Plasma Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2623091
Time frame: Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)
Plasma Pharmacokinetics: Maximum Concentration (Cmax) of LY2623091
Time frame: Day 1 (predose, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose), 24 hours postdose, and every 24 hours thereafter until study release criteria have been met (up to 504 hours)
Total Number of Metabolites of LY2623091 in Plasma, Urine, and Feces
Time frame: Day 1 (predose, 2, 3, 4, 6, 8, and 12 hours postdose), and at 24 and 48 hours postdose

Results and safety

Results posted to the registry on 26 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2623091	6	5

Primary outcome: Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Time frame: Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours). Mean (Standard Deviation). Unit: percentage of radioactive dose recovered

Measure	LY2623091 n = 6
Feces	60.5 (4.27)
Urine	1.39 (0.454)

Population analysed: All participants who received study drug and had quantifiable levels of radioactivity in urine and feces.

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
LY2623091	0 of 6 (0%)	4 of 6 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
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Enrolling by invitationObservational study
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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 LY2623091 in people with Healthy Volunteers, 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 2 inclusion and 0 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 26 Jun 2020. 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 26 Jun 2020). 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?

Urinary and Fecal Excretion of LY2623091 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered (time frame: Screening (urine only), Day -1, Day 1 (0 to 6, 6 to 12, and 12 to 24 hours), and at 24 hour intervals thereafter until the study release criteria have been met (up to 504 hours)). 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 NCT02242981.

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 26 Jun 2020.