Hepatic InsufficiencyPhase 1NCT02387814
A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment
A Phase 1 study testing Abemaciclib in people with Hepatic Insufficiency, run by Eli Lilly and Company at 5 sites in United States.
Trial summary
The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when given to participants with mild, moderate, or severe liver impairment compared to healthy… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Insufficiency
- What is being tested?
- Abemaciclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2015to Aug 2015
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female participants must be of non-child-bearing potential
- Have a body mass index of 18 to 40 kilograms per square meter (kg/m²)
Who cannot join
- No history of cardiovascular, renal, respiratory, gastrointestinal, endocrine or hematological disorders
- Have known allergies to abemaciclib, related compounds, or any components of the formulation
- No human immunodeficiency virus (HIV) infection or antibodies
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Indiana University - Digestive and Liver Diseases
Indianapolis, Indiana, 46202
DaVita Clinical Research
Lakewood, Colorado, 80228
Clinical Pharmacology of Miami (CPMI)
Miami, Florida, 33014
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Orlando Clinical Research Center (OCRC)
Orlando, Florida, 32809
About this study
Official title: A Single-Dose Pharmacokinetic Study of Abemaciclib (LY2835219) in Subjects With Varying Degrees of Hepatic Impairment
The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when given to participants with mild, moderate, or severe liver impairment compared to healthy participants. In addition, the tolerability of the study drug will be evaluated.
This study will last approximately 3 weeks for each participant, including check-in and follow-up.
- Conditions
- Hepatic Insufficiency
- Being tested
- Abemaciclib
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
Also called LY2835219
Administered Orally
| Study group | Role | What they receive |
|---|---|---|
| Abemaciclib: Normal Hepatic Function | Experimental | Single dose of Abemaciclib administered orally on Day 1 to participants with normal hepatic function. Receives: Drug: Abemaciclib |
| Abemaciclib: Mild Hepatic Impairment | Experimental | Single dose of Abemaciclib administered orally on Day 1 to participants with mild hepatic impairment. Receives: Drug: Abemaciclib |
| Abemaciclib: Moderate Hepatic Impairment | Experimental | Single dose of Abemaciclib administered orally on Day 1 to participants with moderate hepatic impairment. Receives: Drug: Abemaciclib |
| Abemaciclib: Severe Hepatic Impairment | Experimental | Single dose of Abemaciclib administered orally on Day 1 to participants with severe hepatic impairment. Receives: Drug: Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Abemaciclib and Active Metabolites
Measured: Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity(AUC[0-inf]) of Abemaciclib and Active Metabolites
Measured: Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2015
- Study completionAug 2015
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 Hepatic InsufficiencyStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT02387814
- Sponsor's protocol ID
- 15538
- Other IDs
- I3Y-MC-JPBV
- Status last verified
- Feb 2019
- First submitted
- 9 Mar 2015
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose Pharmacokinetic Study of Abemaciclib (LY2835219) in Subjects With Varying Degrees of Hepatic Impairment
- ClinicalTrials.gov ID
- NCT02387814
- Acronym / sponsor ID
- 15538
- Conditions
- Hepatic Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Posted 22 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when given to participants with mild, moderate, or severe liver impairment compared to healthy participants. In addition, the tolerability of the study drug will be evaluated.
This study will last approximately 3 weeks for each participant, including check-in and follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Abemaciclib: Normal Hepatic Function | Experimental | Drug: AbemaciclibSingle dose of Abemaciclib administered orally on Day 1 to participants with normal hepatic function. |
| Abemaciclib: Mild Hepatic Impairment | Experimental | Drug: AbemaciclibSingle dose of Abemaciclib administered orally on Day 1 to participants with mild hepatic impairment. |
| Abemaciclib: Moderate Hepatic Impairment | Experimental | Drug: AbemaciclibSingle dose of Abemaciclib administered orally on Day 1 to participants with moderate hepatic impairment. |
| Abemaciclib: Severe Hepatic Impairment | Experimental | Drug: AbemaciclibSingle dose of Abemaciclib administered orally on Day 1 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 (2 listed)
- Female participants must be of non-child-bearing potential
- Have a body mass index of 18 to 40 kilograms per square meter (kg/m²)
Key exclusion criteria (3 listed)
- No history of cardiovascular, renal, respiratory, gastrointestinal, endocrine or hematological disorders
- Have known allergies to abemaciclib, related compounds, or any components of the formulation
- No human immunodeficiency virus (HIV) infection or antibodies
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 |
|---|---|---|
| AbemaciclibAlso: LY2835219Administered Orally | Drug | Abemaciclib: Mild Hepatic Impairment, Abemaciclib: Moderate Hepatic Impairment, Abemaciclib: Normal Hepatic Function, Abemaciclib: Severe Hepatic Impairment |
Primary outcome
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Abemaciclib and Active Metabolites
Time frame: Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity(AUC[0-inf]) of Abemaciclib and Active Metabolites
Time frame: Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- 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
5 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 Abemaciclib in people with Hepatic Insufficiency, run by Eli Lilly and Company at 5 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 2 inclusion and 3 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 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 22 Jan 2019). 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?
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Abemaciclib and Active Metabolites (time frame: Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose). 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 5 Mar 2019.