Hepatic ImpairmentPhase 1NCT03499041
A Study of LY3314814 in Participants With Liver Impairment
A Phase 1 study testing LY3314814 in people with Hepatic Impairment, run by Eli Lilly and Company at 4 sites in United States.
Trial summary
The purpose of the study is to determine whether LY3314814 can be safely prescribed in participants with liver impairment without a dose adjustment. Participants will be on study for 11 days with follow-up about 7 days afterward. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- LY3314814
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2018to Dec 2018
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a Body Mass Index (BMI) of 18 to 40 kilogram per meter square (kg/m²), inclusive, at the time of screening
Who cannot join
- Have a history of or current significant ophthalmic disease, particularly any eye problem involving the retina
- Have moderate or severe vitiligo or any other clinically significant disorder of skin or hair pigmentation
- Have acute unstable neuropsychiatric disease
- Have active or uncontrolled neurologic disease, or clinically significant head injury
Trial locations and contacts
4 sites in 1 country.
United States4 sites
New Orleans Cntr for Clin Res
Knoxville, Tennessee, 37920
Clinical Pharmacology of Miami
Miami, Florida, 33014
Orlando Clinical Research Ctr
Orlando, Florida, 32809
Orange County Research Center
Tustin, California, 92780
About this study
Official title: Pharmacokinetics of LY3314814 in Subjects With Hepatic Impairment
The purpose of the study is to determine whether LY3314814 can be safely prescribed in participants with liver impairment without a dose adjustment. Participants will be on study for 11 days with follow-up about 7 days afterward.
- Conditions
- Hepatic Impairment
- Being tested
- LY3314814
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3314814Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY3314814 Control | Experimental | LY3314814 administered orally to participants with normal hepatic function Receives: Drug: LY3314814 |
| LY3314814 Mild | Experimental | LY3314814 administered orally to participants with mild hepatic impairment Receives: Drug: LY3314814 |
| LY3314814 Moderate | Experimental | LY3314814 administered orally to participants with moderate hepatic impairment Receives: Drug: LY3314814 |
| LY3314814 Severe | Experimental | LY3314814 administered orally to participants with severe hepatic impairment Receives: Drug: LY3314814 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of LY3314814
PK: AUC(0-∞) of LY3314814
Measured: Baseline through 240 hours after the administration of study drug
PK: Maximum Observed Drug Concentration (Cmax) of LY3314814
PK: Cmax of LY3314814
Measured: Baseline through 240 hours after the 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 posted17 Apr 2018
- Study startJun 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Stopped for futility. Phase 3 studies not likely to meet primary endpoints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- 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
- NCT03499041
- Sponsor's protocol ID
- 16003
- Other IDs
- I8D-MC-AZEJ
- Status last verified
- Jun 2018
- First submitted
- 9 Apr 2018
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of LY3314814 in Subjects With Hepatic Impairment
- ClinicalTrials.gov ID
- NCT03499041
- Acronym / sponsor ID
- 16003
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Stopped for futility. Phase 3 studies not likely to meet primary endpoints.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- Jun 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 17 Apr 2018 (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 purpose of the study is to determine whether LY3314814 can be safely prescribed in participants with liver impairment without a dose adjustment. Participants will be on study for 11 days with follow-up about 7 days afterward.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY3314814 Control | Experimental | Drug: LY3314814LY3314814 administered orally to participants with normal hepatic function |
| LY3314814 Mild | Experimental | Drug: LY3314814LY3314814 administered orally to participants with mild hepatic impairment |
| LY3314814 Moderate | Experimental | Drug: LY3314814LY3314814 administered orally to participants with moderate hepatic impairment |
| LY3314814 Severe | Experimental | Drug: LY3314814LY3314814 administered orally to participants with severe hepatic impairment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have a Body Mass Index (BMI) of 18 to 40 kilogram per meter square (kg/m²), inclusive, at the time of screening
Key exclusion criteria (4 listed)
- Have a history of or current significant ophthalmic disease, particularly any eye problem involving the retina
- Have moderate or severe vitiligo or any other clinically significant disorder of skin or hair pigmentation
- Have acute unstable neuropsychiatric disease
- Have active or uncontrolled neurologic disease, or clinically significant head injury
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 |
|---|---|---|
| LY3314814Administered orally | Drug | LY3314814 Control, LY3314814 Mild, LY3314814 Moderate, LY3314814 Severe |
Primary outcome
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of LY3314814
Time frame: Baseline through 240 hours after the administration of study drug
PK: AUC(0-∞) of LY3314814
PK: Maximum Observed Drug Concentration (Cmax) of LY3314814
Time frame: Baseline through 240 hours after the administration of study drug
PK: Cmax of LY3314814
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3314814 in people with Hepatic Impairment, run by Eli Lilly and Company at 4 sites 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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of LY3314814 (time frame: Baseline through 240 hours after the 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 28 Jun 2018.