Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02431481
• Date of registration: 02/04/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011
• Scientific 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
• Date of first enrolment: October 23, 2015
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02431481
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Bulgaria, Czech Republic, Czechia, Germany, Romania, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria (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 (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.

Exclusion Criteria (All Subjects):

- 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

- 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Normal Renal Function

Impaired Renal Function

Intervention(s)

Drug: LEE011

Primary Outcome(s)

Primary Pharmacokinetics (PK) parameters of LEE011 when appropriate [Time Frame: 14 days]

Secondary Outcome(s)

Secondary PK parameters of LEE011 when appropriate [Time Frame: 14 days]

Frequency of adverse events (AEs) [Time Frame: From consent to 28 days post-dose]

PK parameters of LEQ803 (i.e., Cmax, AUClast, AUCinf, Tmax, T1/2) [Time Frame: 14 days]

Secondary ID(s)

CLEE011A2116

Source(s) of Monetary Support

Please refer to primary and secondary sponsors