Healthy VolunteersPhase 1NCT01367262

Disposition of Carbon-14-Labeled LY2886721 ([^14C]-LY2886721) Following Oral Administration in Healthy Human Participants

A Phase 1 study testing LY2886721 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

This open-label study is being conducted to determine the metabolism and physiological disposition of radiolabeled LY2886721 after a single dose in healthy male participants. Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: LY2886721
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: Jun 2011to Jul 2011
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 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males as determined by medical history and physical examination
Males will be sterile (including vasectomy) or if the participant is not sterile and is sexually active, he will agree to use from check-in until 3 months after exit/discharge, 1 of the following approved methods of contraception: a male condom with spermicide, a sterile sexual partner, use by female sexual partner of an intrauterine device with spermicide, a female condom with spermicide, contraceptive sponge with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, intravaginal, or injectable contraceptives
Have a body mass index of 19 to 30 kilograms 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
Have venous access sufficient to allow for blood sampling
Have normal blood pressure and heart rate (sitting)

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Experience a minimum of at least 1 bowel movement per day
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Have given written informed consent approved by Lilly and the institutional review board (IRB) governing the site

Who cannot join

Are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product used in this study; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have known allergies to LY2886721, related compounds, or any components of the formulation
Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2886721
Have a Bazett's corrected QT (QTcB) interval value of >450 milliseconds (msec) or any abnormality in the 12-lead electrocardiogram (ECG) increases the risks associated with participating in the study
Have an abnormal blood pressure
Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

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Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Intend to use prescription medication, over-the-counter medication, or herbal preparations containing St. John's Wort, kava, garlic, ginger, ginko biloba, or guarana within 14 days prior to admission
Eating of grapefruit or grapefruit-containing foods, or drinking grapefruit-containing juices within 7 days prior to dosing or any time during the study
Have used any tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to dosing
Have donated blood of more than 500 milliliters (mL) within the last month
Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65), or are unwilling to stop alcohol consumption from 48 hours prior to check-in until end of study [1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]
Show evidence of significant active neuropsychiatric disease, in particular evidence of significant medical or psychiatric illness within the past 12 months. Have any other condition that would preclude participation in the study
Have a history or presence of epilepsy, a history of seizures, any known brain abnormalities, and a history of significant brain injury
Have participated in a [^14C] study within the last 6 months prior to check-in for this study. The total exposure from this study and the previous study must be within the Code of Federal Regulations (CFR) recommended levels considered safe (per 21 CFR 361.1), less than 5,000 millirems (mrem)/year whole body annual exposure
Exposure to significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
Have a history of clinically significant adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications (all penicillins and cephalosporins may be considered 1 type of medication for this purpose)
Have a history of, or current, significant ophthalmological disease
Have evidence of active renal disease (for example, diabetic renal disease, polycystic kidney disease) or creatinine clearance of <80 milliliters per minute (mL/min) as calculated by Cockcroft-Gault equation: Men: (140-age)*weight in kilograms (kg)/72*[serum creatinine in milligrams per deciliter (mg/dL)]

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]-LY2886721 Following Oral Administration in Healthy Human Subjects

This open-label study is being conducted to determine the metabolism and physiological disposition of radiolabeled LY2886721 after a single dose in healthy male participants.

Conditions: Healthy Volunteers
Being tested: LY2886721
Keywords: Absorption, Distribution, Metabolism, Excretion

What participants receive

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

LY2886721Drug
Administered orally

Study groups in NCT01367262
Study group	Role	What they receive
Radiolabeled LY2886721	Experimental	Single 25 milligram (mg) oral dose containing 80 microCuries of radiolabeled LY2886721 Receives: Drug: LY2886721

What is being measured

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

Percentage of Urinary and Fecal Excretion of LY2886721 Radioactivity Over Time
Urinary and fecal excretion of LY2886721 radioactivity over time was expressed as a percentage of the total radioactive dose administered. The amount of drug-related material excreted in urine and feces (Ae) at a specific collection interval (i) was calculated as the product of radioactivity concentration and volume or weight. The Ae values for each collection interval were then summed and calculated as Total Ae=Ae(i1)+Ae(i2)+Ae(in). The percentage of the total radiolabeled dose administered that was excreted in feces or urine=[(Total Ae)/(Total radioactive dose administered)]*100.
Measured: Predose up to 7 days (168 hours) postdose

Secondary outcomes (7)

Plasma Pharmacokinetics (PK) of LY2886721: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0 to Inf)]
Measured: Predose up to 4 days (96 hours) postdose
PK of Radioactivity: AUC(0 to Inf)
AUC(0 to inf) for plasma and whole blood total radioactivity is reported as hours*nanogram equivalents per milliliter (h*ng Eq/mL).
Measured: Predose up to 4 days (96 hours) postdose
Plasma PK of LY2886721: Maximum Observed Concentration (Cmax)
Measured: Predose up to 4 days (96 hours) postdose
PK of Radioactivity: Cmax
The Cmax of total radioactivity in plasma and whole blood are reported as nanogram equivalents per milliliter (ng Eq/mL).
Measured: Predose up to 4 days (96 hours) postdose
Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Plasma
The metabolites of LY2886721 were identified using a high performance liquid chromatography (HPLC) chromatogram. The relative abundance of LY2886721 and its metabolites in plasma were reported as a percentage of recovered radioactivity and calculated by dividing the sum of the radioactive content of fractions contributing to a particular peak by the sum of the radioactive content of all fractions in the radio chromatogram, then multiplying by 100. Radioactivity corresponds to 80 μCi [^14C]-LY2886721.
Measured: 1 to 8 hours postdose
Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Urine
The metabolites of LY2886721 were identified using an HPLC chromatogram. The relative abundance of LY2886721 and its metabolites in urine were reported as a percentage of recovered radioactivity and calculated by dividing the sum of the radioactive content of fractions contributing to a particular peak by the sum of the radioactive content of all fractions in the radio chromatogram, then multiplying by 100. Radioactivity corresponds to 80 μCi [^14C]-LY2886721.
Measured: 0 to 72 hours postdose
Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Feces
The metabolites of LY2886721 were identified using an HPLC chromatogram. The relative abundance of LY2886721 and its metabolites in feces were reported as a percentage of recovered radioactivity and calculated by dividing the sum of the radioactive content of fractions contributing to a particular peak by the sum of the radioactive content of all fractions in the radio chromatogram, then multiplying by 100. Radioactivity corresponds to 80 μCi [^14C]-LY2886721.
Measured: 0 to 144 hours postdose

Timeline

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

Jun 2011Jul 2011

First posted7 Jun 2011 (estimated)
Study startJun 2011
Primary completionJul 2011
Study completionJul 2011

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

IDs, dates and publications

ClinicalTrials.gov ID: NCT01367262
Sponsor's protocol ID: 13736
Other IDs: I4O-MC-BACD
Status last verified: May 2019
First submitted: 3 Jun 2011
Last updated: 13 Sep 2019
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 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Disposition of [14C]-LY2886721 Following Oral Administration in Healthy Human Subjects
ClinicalTrials.gov ID: NCT01367262
Acronym / sponsor ID: 13736
Conditions: Healthy Volunteers
Keywords: Absorption, Distribution, Metabolism, Excretion
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 7 Jun 2011 (estimated)
Results: Posted 13 Sep 2019

Clinical summary

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

This open-label study is being conducted to determine the metabolism and physiological disposition of radiolabeled LY2886721 after a single dose in healthy male participants.

Study design

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

Arm	Type	Receives
Radiolabeled LY2886721	Experimental	Drug: LY2886721Single 25 milligram (mg) oral dose containing 80 microCuries of radiolabeled LY2886721

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Healthy males as determined by medical history and physical examination
Males will be sterile (including vasectomy) or if the participant is not sterile and is sexually active, he will agree to use from check-in until 3 months after exit/discharge, 1 of the following approved methods of contraception: a male condom with spermicide, a sterile sexual partner, use by female sexual partner of an intrauterine device with spermicide, a female condom with spermicide, contraceptive sponge with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, intravaginal, or injectable contraceptives
Have a body mass index of 19 to 30 kilograms 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
Have venous access sufficient to allow for blood sampling

Key exclusion criteria (22 listed)

Are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product used in this study; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have known allergies to LY2886721, related compounds, or any components of the formulation
Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2886721
Have a Bazett's corrected QT (QTcB) interval value of >450 milliseconds (msec) or any abnormality in the 12-lead electrocardiogram (ECG) increases the risks associated with participating in the study
Have an abnormal blood pressure

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
LY2886721Administered orally	Drug	Radiolabeled LY2886721

Primary outcome

Percentage of Urinary and Fecal Excretion of LY2886721 Radioactivity Over Time
Time frame: Predose up to 7 days (168 hours) postdose
Urinary and fecal excretion of LY2886721 radioactivity over time was expressed as a percentage of the total radioactive dose administered. The amount of drug-related material excreted in urine and feces (Ae) at a specific collection interval (i) was calculated as the product of radioactivity concentration and volume or weight. The Ae values for each collection interval were then summed and calculated as Total Ae=Ae(i1)+Ae(i2)+Ae(in). The percentage of the total radiolabeled dose administered that was excreted in feces or urine=[(Total Ae)/(Total radioactive dose administered)]*100.

7 secondary outcomes

Plasma Pharmacokinetics (PK) of LY2886721: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0 to Inf)]
Time frame: Predose up to 4 days (96 hours) postdose
PK of Radioactivity: AUC(0 to Inf)
Time frame: Predose up to 4 days (96 hours) postdose
Plasma PK of LY2886721: Maximum Observed Concentration (Cmax)
Time frame: Predose up to 4 days (96 hours) postdose
PK of Radioactivity: Cmax
Time frame: Predose up to 4 days (96 hours) postdose
Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Plasma
Time frame: 1 to 8 hours postdose
Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Urine
Time frame: 0 to 72 hours postdose
Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Feces
Time frame: 0 to 144 hours postdose

Results and safety

Results posted to the registry on 13 Sep 2019, 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]-LY2886721	6	6

Primary outcome: Percentage of Urinary and Fecal Excretion of LY2886721 Radioactivity Over Time

Time frame: Predose up to 7 days (168 hours) postdose. Mean (Standard Deviation). Unit: percentage of radioactive dose

Measure	[^14C]-LY2886721 n = 6
Urine	85.7 (2.44)
Feces	8.86 (0.868)

Population analysed: All enrolled participants.

7 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
[^14C]-LY2886721	0 of 6 (0%)	3 of 6 (50%)	Not reported

Limitations and caveats (from the sponsor): Assay sensitivity of plasma and whole blood radioactivity were not generally quantifiable after 24-hours postdose. Consequently, the AUC(0-inf) estimate for total radioactivity in plasma and whole blood should be considered underestimated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
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 LY2886721 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 9 inclusion and 22 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 13 Sep 2019. 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 13 Sep 2019). 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?

Percentage of Urinary and Fecal Excretion of LY2886721 Radioactivity Over Time (time frame: Predose up to 7 days (168 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 NCT01367262.

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 13 Sep 2019.