Normal Hepatic FunctionPhase 1NCT02388620
Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011
A Phase 1 study testing LEE011 in people with Normal Hepatic Function and Impaired Hepatic Function, run by Novartis Pharmaceuticals at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function (based on Child-Pugh classification) as compared to demographically-matched control subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Hepatic Function, Impaired Hepatic Function
- What is being tested?
- LEE011
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Mar 2015to 9 Jan 2017
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Subjects:
- Male or female (sterile or postmenopausal) subjects between 18-75 (both inclusive) years of age and healthy as determined by absence of clinically significant deviation from normal in medical history, physical examination, vital signs, electrocardiograms, and clinical laboratory determinations.
- Subjects must have a BMI between 18 kg/m2 and 36 kg/m2 and weight at least 50 kg and no more than 120 kg.
- Other than hepatic impairment, subjects must be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, (except for additional inclusion criteria described below).
- Subjects in Child-Pugh A, B and C cohorts: Additional inclusion criteria
- Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment
- No change in hepatic status at least one month prior to dosing (i.e. worsening of Child-Pugh score).
Who cannot join
- All Subjects:
- Subject has received a liver transplant at any time in the past and is on immunosuppressant therapy.
- History or presence of impaired cardiac function
- Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism or excretion of drugs
- Administration of CYP3A4/5 inhibitors or inducers or CYP3A4 substrates with narrow therapeutic windows
- Administration of medications that prolong the QT interval
Show all 14Show fewer
- History of immunodeficiency diseases, including HIV, as confirmed by (HIV-1, HIV-2) test.
- Participation in another clinical trial within 4 weeks prior to the study drug administration.
- Subjects with normal hepatic function:
- Additional exclusion criteria A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- Subjects in Child-Pugh A, B and C cohorts:
- Additional exclusion criteria
- Clinical evidence of severe ascites (e.g. requiring regular tapping).
- Bilirubin > 6 mg/dL
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Anaheim Clinical Trials
Anaheim, California, 92801
University of Miami
Coral Gables, Florida, 33124
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Phase I, Open Label, Multi-center, Parallel Cohort, Single Dose Study to Evaluate the Pharmacokinetics of LEE011 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function.
The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function (based on Child-Pugh classification) as compared to demographically-matched control subjects with normal hepatic function.
- Conditions
- Normal Hepatic Function, Impaired Hepatic Function
- Being tested
- LEE011
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEE011Drug
Also called Ribociclib
400 mg
| Study group | Role | What they receive |
|---|---|---|
| Normal Hepatic Function | Experimental | Normal hepatic function; matched demography to hepatic impairment cohorts Receives: Drug: LEE011 |
| Mild Hepatic Impairment | Experimental | Child-Pugh Classification A (score 5-6) Receives: Drug: LEE011 |
| Moderate Hepatic Impairment | Experimental | Child-Pugh Classification B (score 7-9) Receives: Drug: LEE011 |
| Severe Hepatic Impairment | Experimental | Child-Pugh Classification C (score 10-15) Receives: Drug: LEE011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Pharmacokinetic (PK) profile of a single oral dose of LEE011 in subjects with impaired hepatic function as compared to healthy subjects with normal hepatic function.
PK profile includes the following parameters Tmax, Cmax, AUClast, AUCinf, T1/2, CL/F, Vz/F.
Measured: 14 days
Secondary outcomes (1)
Frequency of adverse events (AEs)
Safety profile of a single dose of LEE011 in healthy subjects and subjects with varying degrees of hepatic function includes changes observed in physical examination, changes in vital signs, changes in electrocardiograms (ECGs), abnormal laboratory results.
Measured: From consent to 28 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start25 Mar 2015
- Primary completion9 Jan 2017
- Study completion9 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal Hepatic FunctionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388620
- Sponsor's protocol ID
- CLEE011A2109
- Status last verified
- Dec 2018
- First submitted
- 2 Mar 2015
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Samant TS, Yang S, Miller M, Ji Y. Pharmacokinetics of Ribociclib in Subjects With Hepatic Impairment. J Clin Pharmacol. 2021 Aug;61(8):1001-1009. doi: 10.1002/jcph.1825. Epub 2021 Mar 12.
PubMed 33555033
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Multi-center, Parallel Cohort, Single Dose Study to Evaluate the Pharmacokinetics of LEE011 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function.
- ClinicalTrials.gov ID
- NCT02388620
- Acronym / sponsor ID
- CLEE011A2109
- Conditions
- Normal Hepatic Function, Impaired Hepatic Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2015 (actual)
- Primary completion
- 9 Jan 2017 (actual)
- Study completion
- 9 Jan 2017 (actual)
- First posted
- 17 Mar 2015 (estimated)
- 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 this study is to evaluate the pharmacokinetics (PK), safety and tolerability of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function (based on Child-Pugh classification) as compared to demographically-matched control subjects with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Hepatic Function | Experimental | Drug: LEE011Normal hepatic function; matched demography to hepatic impairment cohorts |
| Mild Hepatic Impairment | Experimental | Drug: LEE011Child-Pugh Classification A (score 5-6) |
| Moderate Hepatic Impairment | Experimental | Drug: LEE011Child-Pugh Classification B (score 7-9) |
| Severe Hepatic Impairment | Experimental | Drug: LEE011Child-Pugh Classification C (score 10-15) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female (sterile or postmenopausal) subjects between 18-75 (both inclusive) years of age and healthy as determined by absence of clinically significant deviation from normal in medical history, physical examination, vital signs, electrocardiograms, and clinical laboratory determinations.
- Subjects must have a BMI between 18 kg/m2 and 36 kg/m2 and weight at least 50 kg and no more than 120 kg.
- Other than hepatic impairment, subjects must be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, (except for additional inclusion criteria described below).
- Subjects in Child-Pugh A, B and C cohorts: Additional inclusion criteria
- Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment
Key exclusion criteria (14 listed)
- Subject has received a liver transplant at any time in the past and is on immunosuppressant therapy.
- History or presence of impaired cardiac function
- Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism or excretion of drugs
- Administration of CYP3A4/5 inhibitors or inducers or CYP3A4 substrates with narrow therapeutic windows
- Administration of medications that prolong the QT interval
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 |
|---|---|---|
| LEE011Also: Ribociclib400 mg | Drug | Mild Hepatic Impairment, Moderate Hepatic Impairment, Normal Hepatic Function, Severe Hepatic Impairment |
Primary outcome
Composite Pharmacokinetic (PK) profile of a single oral dose of LEE011 in subjects with impaired hepatic function as compared to healthy subjects with normal hepatic function.
Time frame: 14 days
PK profile includes the following parameters Tmax, Cmax, AUClast, AUCinf, T1/2, CL/F, Vz/F.
1 secondary outcome
Frequency of adverse events (AEs)
Time frame: From consent to 28 days post-dose
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 19 Dec 2020.
- Derived from this study: PubMed 33555033Samant TS, Yang S, Miller M, Ji Y. Pharmacokinetics of Ribociclib in Subjects With Hepatic Impairment. J Clin Pharmacol. 2021 Aug;61(8):1001-1009. doi: 10.1002/jcph.1825. Epub 2021 Mar 12.
- Results for CLEE011A2109 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Hepatic Impairment
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
3 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 LEE011 in people with Normal Hepatic Function and Impaired Hepatic Function, run by Novartis Pharmaceuticals at 3 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 7 inclusion and 14 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Composite Pharmacokinetic (PK) profile of a single oral dose of LEE011 in subjects with impaired hepatic function as compared to healthy subjects with normal hepatic function. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02388620, which also lists 1 linked publication.
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 19 Dec 2020.