Healthy Male VolunteersPhase 1NCT01577355
A Study of LY2784544 in Healthy Male Subjects
A Phase 1 study testing Drug in people with Healthy Male Volunteers, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This is a single dose study of radiolabelled LY2784544 in healthy male subjects to study the absorption, distribution, metabolism and excretion of LY2784544. 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 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- Drug
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jun 2012
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overtly healthy males as determined by medical history and physical examination
- Will either be sterile or, if sexually active, agree to use a reliable method of birth control from the day before dosing until 3 months after the end of the study
- Have a body mass index (BMI) of 19 to 29 kg/m^2, inclusive
- Have clinical laboratory test results within the normal reference range for the Clinical Research Unit (CRU) or results with acceptable deviations which are judged to be not clinically significant by the investigator
- Normal blood pressure (BP) and heart rate (sitting) as determined by the investigator
- Have venous access sufficient to allow for blood sampling as per the study requirements
- Are reliable and willing to make themselves available for the duration of the study and are willing to abide by the CRU policies and procedures and study restrictions
- Have given written informed consent approved by Lilly and the institutional review board (IRB) governing the CRU
Who cannot join
- Are currently enrolled in, have completed, or discontinued within the last 30 days from a clinical study involving an investigational product 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 LY2784544 or related compounds
- Have previously completed or withdrawn from this study or any other study investigating LY2784544
- 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
- Have a history or evidence of significant active neuropsychiatric disease and in particular evidence of significant medical or psychiatric illness within the past 12 months or have suicidal risk at the time of screening in the opinion of the investigator
- Have any other condition that in the opinion of the investigator would preclude participation in the study
Show all 26Show fewer
- Show evidence of human immunodeficiency virus (HIV) infection 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
- Use of herbal preparations containing St. John's Wort, kava, garlic, ginger, gingko biloba, or guarana within 14 days prior to admission or at any time during the study
- Intent to use over-the-counter (OTC) medication or prescription medication within 7 days prior to dosing or at any time during the study
- Consumption of grapefruit or grapefruit-containing foods or grapefruit-containing juices, Seville oranges or Seville orange juices, and star fruit or star fruit juices within 7 days prior to dosing or at any time during the study
- Have an average weekly alcohol intake that exceeds 21 units per week or are unwilling to stop alcohol consumption for the duration of the study
- Have donated blood of more than 500 mL within the last month
- Have participated in a [14C]-study within the last 6 months prior to admission 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 5000 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)
- Are currently smokers or users of tobacco or nicotine-replacement products within the 6 months prior to study entry
- Baseline 12-lead electrocardiogram (ECG) with a corrected QT (Bazett's) interval of >450 msec and/or have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Have a history of congestive heart failure, unstable angina, myocardial infarction, or documented history of ventricular arrhythmia
- Gastrointestinal disorders causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes
- Evidence of active renal disease (e.g., diabetic renal disease, polycystic kidney disease) or creatinine clearance (CrCl) less than 70 mL/min
- Urinalysis with ≥1+ protein or ≥1+ blood (unless attributable to an acute condition that is resolved prior to dosing)
- Use of drugs with narrow therapeutic windows and that are also known substrates of Cytochrome P450 (CYP)1A2, CYP2B6, and CYP3A are specifically excluded
- Use of antacids and proton pump inhibitors
- Typically do not produce at least one bowel movement per day
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, 53704
About this study
Official title: Disposition of [14C]-LY2784544 Following Oral Administration in Healthy Male Subjects
This is a single dose study of radiolabelled LY2784544 in healthy male subjects to study the absorption, distribution, metabolism and excretion of LY2784544. This study is for research purposes only and is not intended to treat any medical condition.
Read the detailed description
This study is approximately 10 days long, (minimum 5 days, maximum 15 days) not including screening or follow up. Screening is required within 28 days prior to the first dose of study drug and follow up is required at least 7 days after discharge from the clinical research unit.
- Conditions
- Healthy Male Volunteers
- Being tested
- Drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrugRadiation
Single 30 mg oral dose containing 100 micro curies of LY2784544
| Study group | Role | What they receive |
|---|---|---|
| [C14]-LY2784544 | Experimental | Single 30 mg oral dose containing 100 micro curies of LY2784544 Receives: Radiation: Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary and fecal excretion of LY2784544 radioactivity over time expressed as a percentage of the total radioactive dose administered
Measured: Predose up to 14 days post dose
Secondary outcomes (6)
Plasma pharmacokinetics of LY2784544 and radioactivity maximum observed concentration (Cmax)
Measured: Predose up to 14 days post dose
Plasma pharmacokinetics of LY27854544 and radioactivity time of maximum observed concentration (tmax)
Measured: Predose up to 14 days post dose
Plasma pharmacokinetics of LY2784544 and radioactivity area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC 0 to tlast)
Measured: Predose up to 14 days post dose
Relative abundance of LY2784544 and the metabolites of LY2784544 in urine and feces
Measured: Predose up to 14 days post dose
Relative abundance of LY2784544 and the metabolites of LY2784544 in plasma
Measured: Predose up to 14 days post dose
Plasma pharmacokinetics of LY2784544 and radioactivity half-life
Measured: Predose up to 14 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male 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
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- 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
- NCT01577355
- Sponsor's protocol ID
- 14484
- Other IDs
- I3X-MC-JHTD
- Status last verified
- Jul 2012
- First submitted
- 11 Apr 2012
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disposition of [14C]-LY2784544 Following Oral Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01577355
- Acronym / sponsor ID
- 14484
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Apr 2012 (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 radiolabelled LY2784544 in healthy male subjects to study the absorption, distribution, metabolism and excretion of LY2784544. This study is for research purposes only and is not intended to treat any medical condition.
Detailed description
This study is approximately 10 days long, (minimum 5 days, maximum 15 days) not including screening or follow up. Screening is required within 28 days prior to the first dose of study drug and follow up is required at least 7 days after discharge from the clinical research unit.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [C14]-LY2784544 | Experimental | Radiation: DrugSingle 30 mg oral dose containing 100 micro curies of LY2784544 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Overtly healthy males as determined by medical history and physical examination
- Have a body mass index (BMI) of 19 to 29 kg/m^2, inclusive
- Have clinical laboratory test results within the normal reference range for the Clinical Research Unit (CRU) or results with acceptable deviations which are judged to be not clinically significant by the investigator
- Normal blood pressure (BP) and heart rate (sitting) as determined by the investigator
- Have venous access sufficient to allow for blood sampling as per the study requirements
Key exclusion criteria (26 listed)
- Are currently enrolled in, have completed, or discontinued within the last 30 days from a clinical study involving an investigational product 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 LY2784544 or related compounds
- Have previously completed or withdrawn from this study or any other study investigating LY2784544
- 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
- Have a history or evidence of significant active neuropsychiatric disease and in particular evidence of significant medical or psychiatric illness within the past 12 months or have suicidal risk at the time of screening in the opinion of the investigator
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 |
|---|---|---|
| DrugSingle 30 mg oral dose containing 100 micro curies of LY2784544 | Radiation | [C14]-LY2784544 |
Primary outcome
Urinary and fecal excretion of LY2784544 radioactivity over time expressed as a percentage of the total radioactive dose administered
Time frame: Predose up to 14 days post dose
6 secondary outcomes
Plasma pharmacokinetics of LY2784544 and radioactivity maximum observed concentration (Cmax)
Time frame: Predose up to 14 days post dose
Plasma pharmacokinetics of LY27854544 and radioactivity time of maximum observed concentration (tmax)
Time frame: Predose up to 14 days post dose
Plasma pharmacokinetics of LY2784544 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: Predose up to 14 days post dose
Relative abundance of LY2784544 and the metabolites of LY2784544 in urine and feces
Time frame: Predose up to 14 days post dose
Relative abundance of LY2784544 and the metabolites of LY2784544 in plasma
Time frame: Predose up to 14 days post dose
Plasma pharmacokinetics of LY2784544 and radioactivity half-life
Time frame: Predose up to 14 days postdose
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 3 Jul 2012.
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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 Drug in people with Healthy Male 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 8 inclusion and 26 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 3 Jul 2012. 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 LY2784544 radioactivity over time expressed as a percentage of the total radioactive dose administered (time frame: Predose up to 14 days post dose). 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 3 Jul 2012.