NCT01565902

Brief Summary

This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate and severe hepatic impairment compared to healthy control subjects.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2012

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
10 months until next milestone

Results Posted

Study results publicly available

December 22, 2014

Completed
Last Updated

December 29, 2020

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

March 26, 2012

Results QC Date

December 12, 2014

Last Update Submit

December 6, 2020

Conditions

Hepatic Impairment

Keywords

BAF312PharmacokineticsHepatic impairment

Outcome Measures

Primary Outcomes (3)

  • Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)

    The pharmacokinetics of BAF312 were studied in plasma up to 504 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, 312, 408 and 504 hours post dose.

    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, 312, 408 and 504 hours post dose.

  • Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)

    The pharmacokinetics of BAF312 were studied in plasma up to 504 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, 312, 408 and 504 hours post dose.

    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, 312, 408 and 504 hours post dose.

  • Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax)

    The pharmacokinetics of BAF312 were studied in plasma up to 504 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, 312, 408 and 504 hours post dose

    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, 312, 408 and 504 hours post dose

Secondary Outcomes (1)

  • Number of Patients With Adverse Events, Serious Adverse Events and Death Adverse Events (Frequency of Adverse Events, Serious Adverse Events, and Notable Laboratory Abnormalities) of of BAF312 After a Single Dose of BAF312

    Day -1 to 22

Study Arms (4)

Mild hepatically impaired

EXPERIMENTAL

Treatment with a single oral dose of 0.25 mg BAF312

Drug: BAF312

Moderate hepatically impaired

EXPERIMENTAL

Treatment with a single oral dose of 0.25 mg BAF312

Drug: BAF312

Severe hepatically impaired

EXPERIMENTAL

Treatment with a single oral dose of 0.25 mg BAF312

Drug: BAF312

Matched healthy subjects

EXPERIMENTAL

Treatment with a single oral dose of 0.25 mg BAF312

Drug: BAF312

Interventions

BAF312DRUG

Treatment with a single oral dose of 0.25 mg BAF312

Matched healthy subjectsMild hepatically impairedModerate hepatically impairedSevere hepatically impaired

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects:
  • Male and female Caucasian subjects 18 to 70 years of age
  • At least 50 kg and body mass index (BMI) within 18-35 kg/m2.
  • CYP2C9 wild-type (CYP2C9\*1 homozygous carriers)
  • Hepatic impairment:
  • \- Subjects must have either mild, moderate or severe hepatic impairment

You may not qualify if:

  • All subjects
  • Hepatic impairment due to non-liver disease.
  • 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.
  • History of cardiac catheter ablation.
  • Women of child-bearing potential
  • History of malignancy of any organ system
  • Recent and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease)
  • 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.
  • History or presence of coronary heart disease (stable or unstable), myocardial infarction, myocarditis, cardiomyopathy, heart failure NYHA II - IV.
  • Hepatic impairment:
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novartis Investigative Site

Balatonfüred, 8230, Hungary

Location

Novartis Investigative Site

Budapest, 1076, Hungary

Location

Novartis Investigative Site

Moscow, 115419, Russia

Location

Related Links

MeSH Terms

Interventions

siponimod

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 29, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 29, 2020

Results First Posted

December 22, 2014

Record last verified: 2018-02

Locations

RU(1)HU(2)