HealthyPhase 1NCT02914379
A Study of LY3337641 in Healthy Male Participants
A Phase 1 study testing [¹⁴C]-LY3337641 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to measure how much LY3337641 gets into the bloodstream and how long it takes the body to get rid of it. In addition, the safety and tolerability of the study drug will be evaluated. Participants will be admitted to a clinical research unit (CRU) the day before dosing. 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]-LY3337641
- 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 2016to Nov 2016
- 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 medical history and physical examination
- Have a body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²)
- Have clinical laboratory test results within normal reference range for the population or investigative 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 as per the protocol
- Are able and willing to give signed informed consent
- Generally have a minimum of 1 bowel movement per day
Who cannot join
- Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer, if known) should have passed
- Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI) (cholecystectomy not acceptable), endocrine, hematological, dermatologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to dosing
- Have donated blood of more than 500 milliliter (mL) within the month prior to screening
- Have an average weekly alcohol intake that exceeds 21 units per week, and are unwilling to stop alcohol consumption for 48 hours prior to admission, and while resident in the clinical research unit (CRU)
Show all 9Show fewer
- In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
- Have had exposure to significant diagnostic, therapeutic, or employment related radiation within 12 months prior to dosing (serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
- Have participated in a [¹⁴C] study within the last 6 months prior to admission for this study. The total 12-month exposure from this study and a maximum of one other previous [¹⁴C]-study within 6 to 12 months of this study must be within the Code of Federal Regulations (CFR) recommended levels considered safe (per 21 CFR 361.1): less than 5000 Milli-rem (mrem) /year whole body annual exposure
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: Disposition of [¹⁴C]-LY3337641 Following Oral Administration in Healthy Male Subjects
The purpose of this study is to measure how much LY3337641 gets into the bloodstream and how long it takes the body to get rid of it. In addition, the safety and tolerability of the study drug will be evaluated.
Participants will be admitted to a clinical research unit (CRU) the day before dosing. Participants remain confined to the CRU for at least 7 days. Participants may be discharged from the CRU any time after 7 days post-dose (Day 8), and up to a maximum of 21 days post-dose (Day 22).
This study will last approximately 30 days for each participant, not including screening. Screening is required within 28 days prior to the start of the study.
- Conditions
- Healthy
- Being tested
- [¹⁴C]-LY3337641
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[¹⁴C]-LY3337641Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 20mg [¹⁴C]-LY3337641 | Experimental | Participants received 20 milligrams (mg) oral dose of LY3337641 containing 120 microcuries of radioactivity. Receives: Drug: [¹⁴C]-LY3337641 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Urinary excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in urine samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in urine and feces.
Measured: Baseline up to 22 days
Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Fecal excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in fecal samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in feces.
Measured: Baseline up to 22 days
Secondary outcomes (7)
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma LY3337641
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma Radioactivity
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Whole Blood Radioactivity
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma LY3337641
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma Radioactivity
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Whole Blood Radioactivity
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
Pharmacokinetics: Total Number of Measurable Metabolites of LY3337641 in Plasma, Urine and Feces
Measured: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264, and 312 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2016
- Study completionNov 2016
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)
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
- NCT02914379
- Sponsor's protocol ID
- 16297
- Other IDs
- I8K-MC-JPDE
- Status last verified
- Oct 2022
- First submitted
- 21 Sep 2016
- Last updated
- 25 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disposition of [¹⁴C]-LY3337641 Following Oral Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02914379
- Acronym / sponsor ID
- 16297
- 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 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Posted 25 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure how much LY3337641 gets into the bloodstream and how long it takes the body to get rid of it. In addition, the safety and tolerability of the study drug will be evaluated.
Participants will be admitted to a clinical research unit (CRU) the day before dosing. Participants remain confined to the CRU for at least 7 days. Participants may be discharged from the CRU any time after 7 days post-dose (Day 8), and up to a maximum of 21 days post-dose (Day 22).
This study will last approximately 30 days for each participant, not including screening. Screening is required within 28 days prior to the start of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20mg [¹⁴C]-LY3337641 | Experimental | Drug: [¹⁴C]-LY3337641Participants received 20 milligrams (mg) oral dose of LY3337641 containing 120 microcuries of radioactivity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Overtly healthy males, as determined by medical history and physical examination
- Have a body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²)
- Have clinical laboratory test results within normal reference range for the population or investigative 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 as per the protocol
- Are able and willing to give signed informed consent
Key exclusion criteria (9 listed)
- Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer, if known) should have passed
- Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI) (cholecystectomy not acceptable), endocrine, hematological, dermatologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to dosing
- Have donated blood of more than 500 milliliter (mL) within the month prior to screening
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]-LY3337641Administered orally | Drug | 20mg [¹⁴C]-LY3337641 |
Primary outcome
Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Time frame: Baseline up to 22 days
Urinary excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in urine samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in urine and feces.
Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Time frame: Baseline up to 22 days
Fecal excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in fecal samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in feces.
7 secondary outcomes
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma LY3337641
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma Radioactivity
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Whole Blood Radioactivity
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma LY3337641
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma Radioactivity
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Whole Blood Radioactivity
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose
Pharmacokinetics: Total Number of Measurable Metabolites of LY3337641 in Plasma, Urine and Feces
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264, and 312 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- 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]-LY3337641 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 6 inclusion and 9 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 25 Aug 2023. 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 25 Aug 2023). 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 Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered (time frame: Baseline up to 22 days). 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?
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 25 Aug 2023.