HealthyPhase 1NCT02555449

A Study of [¹⁴C]-LY3202626 in Healthy Male Participants

A Phase 1 study testing [¹⁴C]-LY3202626 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

The purpose of this study is to measure how much of the specially prepared study drug, LY3202626, containing radiolabeled carbon [¹⁴C] gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. Read more about this study

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: [¹⁴C]-LY3202626
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 2015to Nov 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 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Are overtly healthy males, as determined by physical examination, clinical laboratory tests, medical history and electrocardiogram (ECG)
Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive at screening

Who cannot join

Have participated in a [¹⁴C]-study within the last 6 months prior to admission for this study
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
Have a history of constipation or have had acute constipation within 3 weeks prior to admission
Are currently or have been smokers or users of tobacco or nicotine replacement products within the 3 months prior to admission and/or have positive cotinine at screening or check-in
Exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (e.g., serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: Disposition of [¹⁴C]-LY3202626 Following Oral Administration in Healthy Male Subjects

Information about any side effects that may occur will also be collected.

Participants will stay at a clinical research unit (CRU). The study will last about 28 days (check in to follow-up) for each participant.

This study is for research purposes only and is not intended to treat any medical condition.

Conditions: Healthy
Being tested: [¹⁴C]-LY3202626

What participants receive

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

[¹⁴C]-LY3202626Drug
Administered as solution by mouth

Study groups in NCT02555449
Study group	Role	What they receive
[¹⁴C]-LY3202626	Experimental	Single oral dose of LY3202626 containing 100 micro curies of radioactivity Receives: Drug: [¹⁴C]-LY3202626

What is being measured

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

Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.
Measured: Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Urinary excretion of radioactivity over time was expressed as a percentage of the total radioactive dose administered
Measured: Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met

Secondary outcomes (5)

Plasma Radioactivity Pharmacokinetics Maximum Observed Concentration (Cmax)
Plasma radioactivity pharmacokinetics were measured by the maximum observed concentration (Cmax).
Measured: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-∞])
Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to infinity (AUC[0-∞]).
Measured: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to the Last Timepoint With a Measurable Concentration (AUC[0-tlast])
Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC[0-tlast]).
Measured: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
Total Number of Metabolites Representing at Least 10% of the Total Radioactivity in Plasma
Total number of metabolites were identified in at least 10% of the total radioactivity in plasma.
Measured: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 Hours Postdose
Total Number of Metabolites in Excreta (Urine and Feces) That Represent at Least 10% of the Dose of Radioactivity
The total number of metabolites identified in excreta (urine and feces) that represent at least 10% of the dose of radioactivity
Measured: From Dosing Until Release Criteria Is Met

Timeline

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

Sep 2015Nov 2015

First posted21 Sep 2015 (estimated)
Study startSep 2015
Primary completionNov 2015
Study completionNov 2015

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

IDs, dates and publications

ClinicalTrials.gov ID: NCT02555449
Sponsor's protocol ID: 15566
Other IDs: I7X-EW-LLCC
Status last verified: Mar 2021
First submitted: 17 Sep 2015
Last updated: 19 Apr 2021
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 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Disposition of [¹⁴C]-LY3202626 Following Oral Administration in Healthy Male Subjects
ClinicalTrials.gov ID: NCT02555449
Acronym / sponsor ID: 15566
Conditions: Healthy
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 2015
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 21 Sep 2015 (estimated)
Results: Posted 19 Apr 2021

Clinical summary

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

Information about any side effects that may occur will also be collected.

Participants will stay at a clinical research unit (CRU). The study will last about 28 days (check in to follow-up) for each participant.

This study is for research purposes only and is not intended to treat any medical condition.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
[¹⁴C]-LY3202626	Experimental	Drug: [¹⁴C]-LY3202626Single oral dose of LY3202626 containing 100 micro curies of radioactivity

Who may qualify

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

Key inclusion criteria (2 listed)

Are overtly healthy males, as determined by physical examination, clinical laboratory tests, medical history and electrocardiogram (ECG)
Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive at screening

Key exclusion criteria (6 listed)

Have participated in a [¹⁴C]-study within the last 6 months prior to admission for this study
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
Have a history of constipation or have had acute constipation within 3 weeks prior to admission
Are currently or have been smokers or users of tobacco or nicotine replacement products within the 3 months prior to admission and/or have positive cotinine at screening or check-in

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
[¹⁴C]-LY3202626Administered as solution by mouth	Drug	[¹⁴C]-LY3202626

Primary outcome

Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Time frame: Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
Fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.
Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Time frame: Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
Urinary excretion of radioactivity over time was expressed as a percentage of the total radioactive dose administered

5 secondary outcomes

Plasma Radioactivity Pharmacokinetics Maximum Observed Concentration (Cmax)
Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-∞])
Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to the Last Timepoint With a Measurable Concentration (AUC[0-tlast])
Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
Total Number of Metabolites Representing at Least 10% of the Total Radioactivity in Plasma
Time frame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 Hours Postdose
Total Number of Metabolites in Excreta (Urine and Feces) That Represent at Least 10% of the Dose of Radioactivity
Time frame: From Dosing Until Release Criteria Is Met

Results and safety

Results posted to the registry on 19 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
[¹⁴C]-LY3202626	6	6

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

Time frame: Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met. Mean (Standard Deviation). Unit: percentage of the total radioactive dose

Measure	[¹⁴C]-LY3202626 n = 6
Value	31.3 (4.24)

Population analysed: All participants who received the study drug and have evaluable pharmacokinetics (PK) data.

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

Time frame: Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met. Mean (Standard Deviation). Unit: percentage of the total radioactive dose

Measure	[¹⁴C]-LY3202626 n = 6
Value	44.2 (3.70)

Population analysed: All participants who received the study drug and have evaluable PK data.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline through End of Study (Up to 2 Months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
[¹⁴C]-LY3202626	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 19 Apr 2021.
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 [¹⁴C]-LY3202626 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 2 inclusion and 6 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 19 Apr 2021. 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 19 Apr 2021). 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?

Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered (time frame: Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met). 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 NCT02555449.

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 19 Apr 2021.