HealthyPhase 1NCT04033341
A Study of LY3214996 in Healthy Participants
A Phase 1 study testing LY3214996 and [14C]-LY3214996 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3214996. This means that a radioactive substance, C14, will be incorporated into the study drug. 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?
- LY3214996 and [14C]-LY3214996
- 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
- 1 Aug 2019to 9 Sep 2019
- 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 health males
- Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
Who cannot join
- Females
- Male participants sexually active with a pregnant partner
- Are currently enrolled in a clinical study or have participated, within the last 30 days, in a clinical study
- Have participated in a radiolabeled drug study within the previous 4 months
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
- Have a history of Gilbert's syndrome
Show all 10Show fewer
- Have history or presence of psychiatric disorders
- Show evidence of human immunodeficiency virus (HIV) infection
- Show evidence of hepatitis C
- Show evidence of hepatitis B
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Inc
Madison, Wisconsin, 53704
About this study
Official title: Disposition of [14C]-LY3214996 Following Oral Administration in Healthy Male Subjects
The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3214996. This means that a radioactive substance, C14, will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to six weeks.
- Conditions
- Healthy
- Being tested
- LY3214996, [14C]-LY3214996
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3214996Drug
Administered orally
[14C]-LY3214996Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY3214996 + [14C]-LY3214996 | Experimental | A single dose of LY3214996 and [14C]-LY3214996 administered orally. Receives: Drug: LY3214996; Drug: [14C]-LY3214996 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
Urinary Excretion of LY3214996 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Measured: Baseline through Day 8 after administration of study drug
Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
Measured: Baseline through Day 8 after administration of study drug
Secondary outcomes (3)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3214996
PK: Cmax of LY3214996
Measured: Predose through Day 8 after administration of study drug
PK: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3214996
PK: AUC(0-∞) of LY3214996
Measured: Predose through Day 8 after administration of study drug
Total Number of Metabolites of LY3214996
Total Number of Metabolites of LY3214996
Measured: Baseline through 48 hours after administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Aug 2019
- Primary completion9 Sep 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- NCT04033341
- Sponsor's protocol ID
- 17199
- Other IDs
- I8S-MC-JUAD
- Status last verified
- Oct 2019
- First submitted
- 24 Jul 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disposition of [14C]-LY3214996 Following Oral Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04033341
- Acronym / sponsor ID
- 17199
- 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
- 1 Aug 2019 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 26 Jul 2019 (actual)
- 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.
The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3214996. This means that a radioactive substance, C14, will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to six weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY3214996 + [14C]-LY3214996 | Experimental | Drug: LY3214996, Drug: [14C]-LY3214996A single dose of LY3214996 and [14C]-LY3214996 administered orally. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Overtly health males
- Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
Key exclusion criteria (10 listed)
- Females
- Male participants sexually active with a pregnant partner
- Are currently enrolled in a clinical study or have participated, within the last 30 days, in a clinical study
- Have participated in a radiolabeled drug study within the previous 4 months
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
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 |
|---|---|---|
| LY3214996Administered orally | Drug | LY3214996 + [14C]-LY3214996 |
| [14C]-LY3214996Administered orally | Drug | LY3214996 + [14C]-LY3214996 |
Primary outcome
Urinary Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
Time frame: Baseline through Day 8 after administration of study drug
Urinary Excretion of LY3214996 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
Time frame: Baseline through Day 8 after administration of study drug
Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
3 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3214996
Time frame: Predose through Day 8 after administration of study drug
PK: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3214996
Time frame: Predose through Day 8 after administration of study drug
Total Number of Metabolites of LY3214996
Time frame: Baseline through 48 hours after administration of study drug
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 29 Oct 2019.
- Individual participant dataSharing planned: No
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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 LY3214996 and [14C]-LY3214996 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 2 inclusion and 10 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 29 Oct 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?
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 Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered (time frame: Baseline through Day 8 after administration of study drug). 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 29 Oct 2019.