Normal Renal FunctionPhase 1NCT02431481
Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011
A Phase 1 study testing LEE011 in people with Normal Renal Function and Impaired Renal Function, run by Novartis Pharmaceuticals at 4 sites in 4 countries.
Trial summary
The purpose of this study is to characterize the PK and safety profile of LEE011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal renal 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 Renal Function, Impaired Renal Function
- What is being tested?
- LEE011
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 23 Oct 2015to 11 May 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 (except for renal impaired subjects).
- Subjects must have a BMI between 18 kg/m2 and 38 kg/m2 and weight at least 50 kg and no more than 120 kg.
- Additional inclusion criteria for subjects with normal renal function:
- An absolute GFR as determined by MDRD equation and conversion within normal range as determined by GFR > 90 mL/min
- Inclusion Criteria (for subjects with impaired renal function):
- Subjects must have documented stable renal disease without evidence of renal progressive disease (stable renal disease is defined as no significant change, such as a stable absolute GFR, for 4 weeks prior to study entry.
Who cannot join
- Subject has received a renal 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
- Subject has a history of immunodeficiency diseases, including HIV, as confirmed by (HIV-1, HIV-2) test
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- Receipt of investigational product in another clinical trial within 4 weeks of dosing
- Exclusion Criteria (for subjects with impaired renal function):
- Severe albuminuria > 300 mg/day
- Subjects undergoing any method of dialysis
- Subjects with renal impairment due to hepatic disease (hepatorenal syndrome)
- Other protocol-defined Inclusion/Exclusion may apply.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
DaVita Clinical Research
Minneapolis, Minnesota, 55404
About this study
Official title: A Phase I, Open Label, Multicenter, Parallel-group, Single Dose Two-staged Study to Evaluate the Pharmacokinetics and Safety of a Single 400 mg Oral Dose of LEE011 in Subjects With Varying Degrees of Impaired Renal Function Compared to Matched Healthy Volunteers With Normal Renal Function
The purpose of this study is to characterize the PK and safety profile of LEE011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal renal function.
- Conditions
- Normal Renal Function, Impaired Renal Function
- Being tested
- LEE011
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEE011Drug
400 mg
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function | Experimental | Normal renal function; matched demography to renal impariment cohorts Receives: Drug: LEE011 |
| Severe renal impairment | Experimental | Severe decrease in GFR (15-29 ml/min) Receives: Drug: LEE011 |
| End Stage Renal Disease | Experimental | End stage renal disease not on dialysis; GFR <15 ml/min Receives: Drug: LEE011 |
| Mild renal impairment | Experimental | Mild decrease in GFR (60-89 ml/min) Receives: Drug: LEE011 |
| Moderate renal impairment | Experimental | Moderate decrease in GFR (30-59 ml/min) Receives: Drug: LEE011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Pharmacokinetics (PK) parameters of LEE011 when appropriate
Primary composite PK parameters: Cmax, AUClast, AUCinf, and CL/F. To determine the impact of various degrees of renal impairment on primary PK parameters of LEE011 following a single 400mg oral dose
Measured: 14 days
Secondary outcomes (3)
Secondary PK parameters of LEE011 when appropriate
Secondary composite PK parameters of LEE011: Tmax, T1/2, Vz/F, and CLr. To determine the impact of various degrees of renal impairment on secondary PK parameters of LEE011 following a single 400 mg oral dose
Measured: 14 days
PK parameters of LEQ803 (i.e., Cmax, AUClast, AUCinf, Tmax, T1/2)
Composite PK parameters of LEQ803: Cmax, AUClast, AUCinf, Tmax, T1/2. To evaluate the PK profile of LEQ803 in subjects with various degrees of renal impairment following a single 400 mg oral dose
Measured: 14 days
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 posted1 May 2015 (estimated)
- Study start23 Oct 2015
- Primary completion14 Sep 2017
- Study completion11 May 2018
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 Renal 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
- 38 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
- NCT02431481
- Sponsor's protocol ID
- CLEE011A2116
- Status last verified
- Feb 2019
- First submitted
- 2 Apr 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
Ji Y, Yartsev V, Quinlan M, Serra P, Wang Y, Chakraborty A, Miller M. Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials. Clin Pharmacokinet. 2023 Mar;62(3):493-504. doi: 10.1007/s40262-022-01206-2. Epub 2023 Feb 17.
PubMed 36800111
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, Multicenter, Parallel-group, Single Dose Two-staged Study to Evaluate the Pharmacokinetics and Safety of a Single 400 mg Oral Dose of LEE011 in Subjects With Varying Degrees of Impaired Renal Function Compared to Matched Healthy Volunteers With Normal Renal Function
- ClinicalTrials.gov ID
- NCT02431481
- Acronym / sponsor ID
- CLEE011A2116
- Conditions
- Normal Renal Function, Impaired Renal Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2015 (actual)
- Primary completion
- 14 Sep 2017 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 1 May 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 characterize the PK and safety profile of LEE011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal renal function | Experimental | Drug: LEE011Normal renal function; matched demography to renal impariment cohorts |
| Severe renal impairment | Experimental | Drug: LEE011Severe decrease in GFR (15-29 ml/min) |
| End Stage Renal Disease | Experimental | Drug: LEE011End stage renal disease not on dialysis; GFR <15 ml/min |
| Mild renal impairment | Experimental | Drug: LEE011Mild decrease in GFR (60-89 ml/min) |
| Moderate renal impairment | Experimental | Drug: LEE011Moderate decrease in GFR (30-59 ml/min) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 (except for renal impaired subjects).
- Subjects must have a BMI between 18 kg/m2 and 38 kg/m2 and weight at least 50 kg and no more than 120 kg.
- Additional inclusion criteria for subjects with normal renal function:
- Subjects must have documented stable renal disease without evidence of renal progressive disease (stable renal disease is defined as no significant change, such as a stable absolute GFR, for 4 weeks prior to study entry.
Key exclusion criteria (12 listed)
- Subject has received a renal 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 |
|---|---|---|
| LEE011400 mg | Drug | End Stage Renal Disease, Mild renal impairment, Moderate renal impairment, Normal renal function, Severe renal impairment |
Primary outcome
Primary Pharmacokinetics (PK) parameters of LEE011 when appropriate
Time frame: 14 days
Primary composite PK parameters: Cmax, AUClast, AUCinf, and CL/F. To determine the impact of various degrees of renal impairment on primary PK parameters of LEE011 following a single 400mg oral dose
3 secondary outcomes
Secondary PK parameters of LEE011 when appropriate
Time frame: 14 days
PK parameters of LEQ803 (i.e., Cmax, AUClast, AUCinf, Tmax, T1/2)
Time frame: 14 days
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 36800111Ji Y, Yartsev V, Quinlan M, Serra P, Wang Y, Chakraborty A, Miller M. Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials. Clin Pharmacokinet. 2023 Mar;62(3):493-504. doi: 10.1007/s40262-022-01206-2. Epub 2023 Feb 17.
- Results for CLEE011A2116 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
- 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 4 countries: 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 Renal Function and Impaired Renal Function, run by Novartis Pharmaceuticals at 4 sites in 4 countries.
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 6 inclusion and 12 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 4 sites in United States, Bulgaria, Czechia, Germany. 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?
Primary Pharmacokinetics (PK) parameters of LEE011 when appropriate (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 NCT02431481, 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.