Healthy VolunteersPhase 1NCT01965782
A Study of [14C]-LY3023703 in Healthy Participants
A Phase 1 study testing [^14C]-LY3023703 in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This type of study is called a radiolabeled study. For this study, LY3023703 (study drug) has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring radioactive form of the element carbon. 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 Volunteers
- What is being tested?
- [^14C]-LY3023703
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2013
- 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
- Participants will either be sterile or, if sexually active, agree to use approved methods of contraception from the day before dosing until 3 months after the follow-up assessment
- Participants will refrain from sperm donation from the day before dosing until 3 months after the follow-up assessment
- Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (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 given written informed consent approved by Lilly and the IRB governing the site
Who cannot join
- Are currently enrolled in, have participated, within the last 30 days, in a clinical trial 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
- Are participants who have previously completed or withdrawn from this study or any other study investigating LY3023703, and have previously received the investigational product
- Have known allergies to LY3023703, related compounds or any components of the formulation, or history of significant atopy
- Have recent or ongoing gastrointestinal (GI) symptoms or illnesses, have a history of GI bleeding or perforation, related to previous nonsteroidal anti-inflammatory drug (NSAID) or cyclooxygenase (COX)2 inhibitor therapy or have active or history of recurrent peptic ulcer/hemorrhage (2 or more distinct episodes of proven ulceration or bleeding)
- Have a history of intolerance to NSAIDs or aspirin
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show all 17Show fewer
- Show evidence of alanine aminotransferase or aspartate aminotransferase levels above the normal ranges, confirmed on repeat, or a history of elevated and abnormal liver tests
- Have intended use of over-the-counter medications or prescription medication within 14 days prior to dosing. Also within 30 days prior to dosing, any drugs and dietary items that are known inducers or inhibitors of cytochrome P450 (CYP) 3A or CYP2J2 or other drugs that may affect the disposition of LY3023703 or increase risk for complications from the study
- Have consumed herbal supplements within 14 days prior to admission or grapefruit juice, grapefruits, grapefruit-containing products, Seville orange juice, Seville oranges, star fruit, or star fruit juice within 7 days prior to dosing or intend to consume during the study
- Have donated blood of more than 500 milliliter (mL) within the last month
- Have participated in a [14C]-study within the last 6 months prior to admission for this study
- 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)
- A positive alcohol breathalyzer test
- A positive cotinine test
- Are unwilling to refrain from consuming xanthine-containing food and drink from 48 hours prior to admission until discharge from the Clinical Research Unit (CRU)
- Have a defecation pattern less than once per 2 days or acute constipation within 3 weeks of the day before dosing
- In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
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]-LY3023703 Following Oral Administration in Healthy Subjects
This type of study is called a radiolabeled study. For this study, LY3023703 (study drug) has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring radioactive form of the element carbon. This study will help understand how the drug appears in the blood, urine, and stool after it is administered to healthy men. Information about any side effects that may occur will also be collected. This study will last up to 15 days for each participant, not including screening. Screening is required within 28 days prior to the start of the study.
- Conditions
- Healthy Volunteers
- Being tested
- [^14C]-LY3023703
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[^14C]-LY3023703Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| [^14C]-LY3023703 | Experimental | Single oral dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution. Receives: Drug: [^14C]-LY3023703 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Excretion of LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Measured: Predose up to 168 hours post dose
Urinary Excretion of LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Measured: Predose up to 168 hours post dose
Secondary outcomes (5)
Pharmacokinetics of LY3023703 and Radioactivity Maximum Observed Concentration (Cmax)
Measured: Predose up to 168 hours post dose
Pharmacokinetics of LY3023703 and Radioactivity Time of Maximum Observed Concentration (Tmax)
Measured: Predose up to 168 hours post dose
Pharmacokinetics of LY3023703 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 168 hours post dose
Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Urine and Feces
Measured: Predose up to 168 hours post dose
Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Plasma
Measured: One hour post-dose up to 72 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Due to safety results from another trial of LY3023703. No participants in this study received study drug.
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT01965782
- Sponsor's protocol ID
- 15097
- Other IDs
- I6H-MC-MCBD
- Status last verified
- Jul 2018
- First submitted
- 16 Oct 2013
- Last updated
- 28 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disposition of [14C]-LY3023703 Following Oral Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01965782
- Acronym / sponsor ID
- 15097
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to safety results from another trial of LY3023703. No participants in this study received study drug.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Posted 16 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This type of study is called a radiolabeled study. For this study, LY3023703 (study drug) has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring radioactive form of the element carbon. This study will help understand how the drug appears in the blood, urine, and stool after it is administered to healthy men. Information about any side effects that may occur will also be collected. This study will last up to 15 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 |
|---|---|---|
| [^14C]-LY3023703 | Experimental | Drug: [^14C]-LY3023703Single oral dose of 15 mg LY3023703, containing approximately 100 µCi [^14C] labeled drug, administered as an oral solution. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants will either be sterile or, if sexually active, agree to use approved methods of contraception from the day before dosing until 3 months after the follow-up assessment
- Participants will refrain from sperm donation from the day before dosing until 3 months after the follow-up assessment
- Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (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 given written informed consent approved by Lilly and the IRB governing the site
Key exclusion criteria (17 listed)
- Are currently enrolled in, have participated, within the last 30 days, in a clinical trial 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
- Are participants who have previously completed or withdrawn from this study or any other study investigating LY3023703, and have previously received the investigational product
- Have known allergies to LY3023703, related compounds or any components of the formulation, or history of significant atopy
- Have recent or ongoing gastrointestinal (GI) symptoms or illnesses, have a history of GI bleeding or perforation, related to previous nonsteroidal anti-inflammatory drug (NSAID) or cyclooxygenase (COX)2 inhibitor therapy or have active or history of recurrent peptic ulcer/hemorrhage (2 or more distinct episodes of proven ulceration or bleeding)
- Have a history of intolerance to NSAIDs or aspirin
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]-LY3023703Administered orally | Drug | [^14C]-LY3023703 |
Primary outcome
Fecal Excretion of LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Time frame: Predose up to 168 hours post dose
Urinary Excretion of LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Time frame: Predose up to 168 hours post dose
5 secondary outcomes
Pharmacokinetics of LY3023703 and Radioactivity Maximum Observed Concentration (Cmax)
Time frame: Predose up to 168 hours post dose
Pharmacokinetics of LY3023703 and Radioactivity Time of Maximum Observed Concentration (Tmax)
Time frame: Predose up to 168 hours post dose
Pharmacokinetics of LY3023703 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 168 hours post dose
Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Urine and Feces
Time frame: Predose up to 168 hours post dose
Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Plasma
Time frame: One hour post-dose up to 72 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Screening Protocol
Pain
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]-LY3023703 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 5 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: stopped early, as of the sponsor's last update on 28 Aug 2018. 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 16 Jul 2018). 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 LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered (time frame: Predose up to 168 hours post dose). 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 28 Aug 2018.