Back to results

A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

BAF312

About this trial

This is an interventional other trial for Renal Impairment focused on measuring renal impairement, pharmacokinetics

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All subjects:

At least 50 kg and body mass index (BMI) within 18-38 kg/m2.
CYP2C9 wild-type (CYP2C9*1 homozygous carriers)

Renal impairment:

- Subjects must have either mild, moderate or severe renal impairment

Exclusion Criteria:

All subjects

Use of other investigational drugs within certain timelines
Donation or loss of 400 mL or more of blood or plasma within eight (8) weeks prior to initial dosing
History of cardiac rhythm abnormalities or cardiac rhythm abnormalities identified in the 24-h Holter ECG recording including episodes of bradycardia (HR < 50 bpm) during waking hours and/or arrhythmic episodes; subjects with history or presence of ventricular rhythm disturbances (ventricular extra-systoles >100/24h, or higher grade), or supraventricular arrhythmias (other than occasional supraventricular ectopic beats with a maximum of 5 subsequent ectopic beats per event) or subjects with conduction disturbances (higher than AV-block grade 1) or bradycardia or tachycardia.
Women of child-bearing potential
History of malignancy of any organ system
History or presence of symptomatic postural hypotension or syncope.
Total WBC or lymphocyte counts which falls outside the 1.5-fold local laboratory normal range or platelet count < 30,000/μL at screening or baseline.
Clinically significant infection or recent vaccination with live-attenuated vaccines.
History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.

Renal impairment:

History or presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
Any surgical or medical condition other than renal impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study.
Treatment with certain drugs

Healthy subjects:

History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases.
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, drugs, or which may jeopardize the subject in case of participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

severe renal impairmnt

moderate renal impairment

mild renal impairment

healthy subjects

Arm Description

Outcomes

Primary Outcome Measures

Pharmacokinetic parameters of BAF312 and selected metabolites

The pharmacokineticsof BAF312 will be studied in plasma up to 312 (+/-24) hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, and 312 (+/-24) hours post dose. Selected metabolites will also be quantified using the same samples as described above. Free plasma circulating fraction of BAF312 will also be investigated to assess whether protein binding is affected by renal impairment. For this purpose a separate blood sample will be taken at the following time point: 4 hours post-dose.

Secondary Outcome Measures

Number of participants with Adverse Events as a measure of Safety and Tolerability

Physical examination, vital signs, body temperature, standard safety laboratory evaluations (hematology, clinical chemistry, coagulation, Hepatitis B and C and HIV serology, pregnancy test, alcohol and drug screen), standard 12-lead electrocardiogram , cardiac monitoring, 24-h Holter ECG, (serious) adverse event monitoring.

Full Information

NCT ID

NCT01904214

First Posted

July 17, 2013

Last Updated

December 6, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01904214

Brief Title

A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

to quantify the effect of different degrees of renal impairment on the pharmacokinetics of BAF312 (and selected metabolites) and to assess safety and tolerability in order to develop dosing recommendations for subjects with renal impairment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment

Keywords

renal impairement, pharmacokinetics

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

severe renal impairmnt

Arm Type

Experimental

Arm Title

moderate renal impairment

Arm Type

Experimental

Arm Title

mild renal impairment

Arm Type

Experimental

Arm Title

healthy subjects

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BAF312

Intervention Description

Treatment with a single oral dose of 0.25 mg BAF312

Primary Outcome Measure Information:

Title

Pharmacokinetic parameters of BAF312 and selected metabolites

Description

Time Frame

pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, and 312 hours post dose

Secondary Outcome Measure Information:

Title

Number of participants with Adverse Events as a measure of Safety and Tolerability

Description

Time Frame

Day 1 - Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All subjects: At least 50 kg and body mass index (BMI) within 18-38 kg/m2. CYP2C9 wild-type (CYP2C9*1 homozygous carriers) Renal impairment: - Subjects must have either mild, moderate or severe renal impairment Exclusion Criteria: All subjects Use of other investigational drugs within certain timelines Donation or loss of 400 mL or more of blood or plasma within eight (8) weeks prior to initial dosing History of cardiac rhythm abnormalities or cardiac rhythm abnormalities identified in the 24-h Holter ECG recording including episodes of bradycardia (HR < 50 bpm) during waking hours and/or arrhythmic episodes; subjects with history or presence of ventricular rhythm disturbances (ventricular extra-systoles >100/24h, or higher grade), or supraventricular arrhythmias (other than occasional supraventricular ectopic beats with a maximum of 5 subsequent ectopic beats per event) or subjects with conduction disturbances (higher than AV-block grade 1) or bradycardia or tachycardia. Women of child-bearing potential History of malignancy of any organ system History or presence of symptomatic postural hypotension or syncope. Total WBC or lymphocyte counts which falls outside the 1.5-fold local laboratory normal range or platelet count < 30,000/μL at screening or baseline. Clinically significant infection or recent vaccination with live-attenuated vaccines. History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening. Renal impairment: History or presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk. Any surgical or medical condition other than renal impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study. Treatment with certain drugs Healthy subjects: History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, drugs, or which may jeopardize the subject in case of participation in the study. Other protocol-defined inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

Novartis Investigative Site

City

Bucuresti

Country

Romania

12. IPD Sharing Statement

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=14230

Description

Results for CBAF312A2129 can be found on the Novartis Clinical Trial Results website

URL

https://www.ncbi.nlm.nih.gov/pubmed/27841151

Description

Pubmed publication

Learn more about this trial

A Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of BAF312 in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

We'll reach out to this number within 24 hrs