Pharmacokinetic Study of Buparlisib in Subjects With Renal Impairment.

NCT ID: NCT02048787

Last Updated: 2020-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-03-31

Brief Summary

To characterize the pharmacokinetics and safety of buparlisib following a single 50 mg oral dose in subjects with moderate and severe renal impairment.

Conditions

Renal Impairment

Keywords

Renal impairment; Healthy volunteers; Clinical pharmacology study

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Moderate renal impairment group

Subjects with moderate renal impairment defined as eGFR of 30-59 mL/min/1.73m2 at screening can be enrolled in this group

Group Type: EXPERIMENTAL

Buparlisib

Intervention Type: DRUG

Subjects will receive a single dose of 50 mg buparlisib.

Severe renal impairment group

Subjects with severe renal impairment defined as eGFR of 15-29 mL/min/1.73m2 at screening can be enrolled in this group

Group Type: EXPERIMENTAL

Buparlisib

Intervention Type: DRUG

Subjects will receive a single dose of 50 mg buparlisib.

Matching healthy control group

Subjects with normal renal function defined as eGFR ≥ 90 mL/min/1.73m2 at screening and matching to the renal impaired subject based on gender, race, age, and weight can be enrolled in this group.

Group Type: EXPERIMENTAL

Buparlisib

Intervention Type: DRUG

Subjects will receive a single dose of 50 mg buparlisib.

Interventions

Buparlisib

Subjects will receive a single dose of 50 mg buparlisib.

Intervention Type: DRUG

Other Intervention Names

BKM120

Eligibility Criteria

Inclusion Criteria

• Subjects must have a BMI between 18 kg/m2 and 34 kg/m2 and weight at least 50 kg and no more than 120 kg.

• Additional criteria for renal impaired subjects: - Subjects must have stable renal disease without evidence of renal progressive disease defined as moderate renal impairment (eGFR 30-59 mL/min/1.73m2) or severe renal impairment (eGFR 15-29 mL/min/1.73m2).
• Additional criteria for matched healthy control subjects: - Matched to at least one renal impaired subject by gender, race, age (± 10 years), and weight (± 20%).
• An estimated GFR as determined by MDRD equation within normal range as determined by eGFR ≥ 90 mL/min/1.73m2

Exclusion Criteria

• Significant illness, including infections, or hospitalization within the 2 weeks prior to dosing, except for the renal impaired subjects who due to their renal disease may be affected by significant medical problems which require frequent hospitalizations.
• Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study
• Subject has a medical history of cardiac disease and/or clinically significant ECG abnormalities within 6 months prior to screening.
• Subject has an active or a history within 6 months prior to screening of clinically significant hematologic, endocrinologic, pulmonary, cardiovascular, hepatic, or allergic disease, medically documented (other than clinical conditions associated with renal impairment for the renal impaired subjects only).
• Subjects undergoing any method of dialysis.
• Subjects with renal impairment due to hepatic disease (hepatorenal syndrome).
• Subjects with clinically significant abnormal findings, not consistent with clinical disease, upon physical examination, ECG or laboratory evaluation.
• Use of any prescription or non-prescription medication that has the potential to interact with buparlisib within two weeks prior to dosing or during the study.
• - Additional criteria for matched healthy control subjects: - Use of any prescription or non-prescription medication or vitamins during 14 days prior to dosing.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Sofia, , Bulgaria

Novartis Investigative Site

Prague, , Czechia

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Bucharest, , Romania

Countries

Russia; Bulgaria; Czechia; Germany; Romania

Related Links

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=14390

Results can be found for CBKM120C2113 on the Novartis Clinical Trial Results Website

Other Identifiers

2013-003384-64

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBKM120C2113

Identifier Type: -

Identifier Source: org_study_id