Healthy subjects
Conditions
Interventions
Sponsors
Novartis Pharmaceuticals Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy male or female between 18-55 years. - Females of child bearing potential who were willing during the entire study period to use one or more of the acceptable methods of contraception. - Subjects weighing 60-100kg witha body mass index 18-33kg/m² -Serum ferritin >=20ng/mL, total iron-binding capacity in the range of 250-450 ?g/dL, and iron: total iron-binding capacity ratio >= 15% at visit 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History or presence of hematological disorders -History or presence of ophtalmic symptoms or disorders - History or presence of clinical manifestations of postural hypotension. - History or presence of any active medical conditions or clinically significant findings that might have altered the absorption, distribution, metabolism or excretion of deferasirox, as judged to be relevant by the investigator - Use of investigational drugs within 5 elimination half-lives or participation in any other clinical trial within 4 weeks prior to visit 1, whichever was longer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the PK comparability of a reduced dose of the deferasirox granule formulation given with a small amount of a soft food matrix (apple sauce) versus the reference dispersible tablet formulation of deferasirox under fasted conditions in healthy subjects.;Secondary Objective: Evaluate the safety and tolerability of deferasirox granule formulation in comparison to the reference DT formulation. ;Primary end point(s): -Primary PK parameters: AUClast, AUCinf and Cmax. -Secondary PK parameters: Tmax, T1/2, and Lambda_z;Timepoint(s) of evaluation of this end point: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety assessments such as AEs, vitals, ECGs and laboratory parameters;Timepoint(s) of evaluation of this end point: 30 days after End of Treatment Visit | — |
Countries
United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed