Healthy VolunteersPhase 1NCT01275157
Disposition of 14C-LY2452473 Following Oral Administration in Healthy Human Subjects
A Phase 1 study testing LY2452473 in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This is a single dose study of radiolabeled [14C]-LY2452473 in healthy male volunteers to study the absorption, distribution, metabolism, and elimination of LY2452473. This study is for research purposes only and is not intended to treat any medical condition. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- LY2452473
- 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
- Jan 2011to Feb 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Experience on average 1 to 2 bowel movements per day
- Overtly healthy males, as determined by medical history and physical examination
- Subjects will either be sterile or, if sexually active, agree to use a reliable method of birth control from check-in until 3 months after the follow-up assessment
- Are between the body mass index (BMI) of 19 and 29 kg^m2, inclusive
- Clinical laboratory test results within the normal reference range for the clinical research unit laboratory or results with acceptable deviations which are judged to be not clinically significant by the investigator
- Have venous access sufficient to allow blood sampling
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- Normal blood pressure and pulse rate (sitting) as determined by the investigator
- 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, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device other than the study drug 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 LY2452473 or related compounds
- Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study medication or interfering with the interpretation of data
- Have any other condition that in the opinion of the investigator would preclude participation in the study
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
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- Show evidence of human immunodeficiency virus (HIV) and/or positive human 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
- Intended use of over-the-counter or herbal medication within 7 days or prescription medication within 14 days prior to dosing
- Have donated more than 500 mL of blood within the last month
- Have an average weekly alcohol intake that exceeds 14 units per week, or are unwilling to stop alcohol consumption for the duration of the study (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
- Use of herbal preparations containing St. John's Wort, kava, garlic, ginger, gingko biloba, or guarana within 14 days prior to admission
- Consumption of grapefruit or grapefruit-containing foods or juices within 7 days prior to dosing or any time during the study
- Heavy caffeine drinkers defined by a regular intake of more than 5 cups (40-50 mg of caffeine per cup) of coffee (or equivalent in xanthine-containing beverages) per day or caffeine drinking subjects who have not had consistent daily caffeine consumption for 1 month prior to study entry or subjects not willing to maintain consistent caffeine consumption during the study
- Have participated in a [14C]-study within the last 12 months. The previous radiolabeled study drug must have been received more than 6 months prior to Check-in for this study and the cumulative annual radiation exposure must be consistent with Food and Drug Administration (FDA) recommendations, for example whole body exposure less than 5,000 mrem/year
- 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)
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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madison, Wisconsin
About this study
Official title: Disposition of [14C]-LY2452473 Following Oral Administration in Healthy Human Subjects
This is a single dose study of radiolabeled [14C]-LY2452473 in healthy male volunteers to study the absorption, distribution, metabolism, and elimination of LY2452473.
This study is for research purposes only and is not intended to treat any medical condition.
- Conditions
- Healthy Volunteers
- Being tested
- LY2452473
- Keywords
- Absorption, Distribution, Metabolism, Excretion, Mass balance, Metabolic profile, Radiolabeled study, 14C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2452473Drug
Administered orally as a liquid suspension
| Study group | Role | What they receive |
|---|---|---|
| LY2452473 | Experimental | 15 mg, containing 100 micro curies of 14C labeled LY2452473 taken once only Receives: Drug: LY2452473 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered
Measured: baseline up to 22 days
Secondary outcomes (5)
Plasma pharmacokinetics of LY2452473 and radioactivity maximum observed concentration (Cmax)
Measured: baseline up to 22 days
Plasma pharmacokinetics of LY2452473 and radioactivity time of maximum observed concentration (tmax)
Measured: baseline up to 22 days
Plasma pharmacokinetics of LY2452473 and radioactivity area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC 0 to tlast)
Measured: baseline up to 22 days
Relative abundance of LY2452473 and the metabolites of LY2452473 in urine and feces
Measured: baseline up to 22 days
Relative abundance of LY2452473 and the metabolites of LY2452473 in plasma
Measured: baseline up to 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275157
- Sponsor's protocol ID
- 13276
- Other IDs
- I2N-MC-GPBF
- Status last verified
- Apr 2011
- First submitted
- 10 Jan 2011
- Last updated
- 15 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disposition of [14C]-LY2452473 Following Oral Administration in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT01275157
- Acronym / sponsor ID
- 13276
- Conditions
- Healthy Volunteers
- Keywords
- Absorption, Distribution, Metabolism, Excretion, Mass balance, Metabolic profile, Radiolabeled study, 14C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 12 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single dose study of radiolabeled [14C]-LY2452473 in healthy male volunteers to study the absorption, distribution, metabolism, and elimination of LY2452473.
This study is for research purposes only and is not intended to treat any medical condition.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY2452473 | Experimental | Drug: LY245247315 mg, containing 100 micro curies of 14C labeled LY2452473 taken once only |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Experience on average 1 to 2 bowel movements per day
- Overtly healthy males, as determined by medical history and physical examination
- Subjects will either be sterile or, if sexually active, agree to use a reliable method of birth control from check-in until 3 months after the follow-up assessment
- Are between the body mass index (BMI) of 19 and 29 kg^m2, inclusive
- Clinical laboratory test results within the normal reference range for the clinical research unit laboratory or results with acceptable deviations which are judged to be not clinically significant by the investigator
Key exclusion criteria (17 listed)
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device other than the study drug 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 LY2452473 or related compounds
- Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study medication or interfering with the interpretation of data
- Have any other condition that in the opinion of the investigator would preclude participation in the study
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 |
|---|---|---|
| LY2452473Administered orally as a liquid suspension | Drug | LY2452473 |
Primary outcome
Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered
Time frame: baseline up to 22 days
5 secondary outcomes
Plasma pharmacokinetics of LY2452473 and radioactivity maximum observed concentration (Cmax)
Time frame: baseline up to 22 days
Plasma pharmacokinetics of LY2452473 and radioactivity time of maximum observed concentration (tmax)
Time frame: baseline up to 22 days
Plasma pharmacokinetics of LY2452473 and radioactivity area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC 0 to tlast)
Time frame: baseline up to 22 days
Relative abundance of LY2452473 and the metabolites of LY2452473 in urine and feces
Time frame: baseline up to 22 days
Relative abundance of LY2452473 and the metabolites of LY2452473 in plasma
Time frame: baseline up to 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2011.
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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 LY2452473 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 17 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 15 Apr 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 radioactivity over time expressed as a percentage of the total radioactive dose administered (time frame: baseline up to 22 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2011.