Pharmacokinetics, Pharmacodynamics, and Safety Study of Ticagrelor in Hemodialysis Patients and Healthy Subjects
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I, open-label study comparing the pharmacokinetics, pharmacodynamics, safety and
      tolerability of ticagrelor in hemodialysis patients to healthy subjects with normal renal
      function.
    

Detailed description: 
      This will be a single dose, randomised, open label, parallel group study conducted in the US
      to examine the Pharmacokinetics (PK), Pharmacodynamics (PD), safety, and tolerability of
      ticagrelor in end stage renal disease (ESRD) subjects on hemodialysis (HD) compared with
      healthy subjects with normal renal function. Up to a total of 30 male and female adult
      subjects aged 18 to 80 years (inclusive) with a weight of at least 50 kg and a body mass
      index between 18 and 40 kg/m2 (inclusive), will be dosed to assure that there will be 20
      evaluable subjects (10 subjects on HD and in 10 healthy subjects with normal renal function
      (CrCL ≥90 mL/min). The normal renal function groups should have a similar distribution with
      respect to age, weight and gender. Subjects will be required to have an inpatient stay from
      the day prior to dosing until the 48-hour post-dose time-point to ensure that all PK samples
      are collected at the appropriate timepoints. The study will be conducted in two groups: Group
      A consisting of ESRD subjects on HD, Group B consisting of healthy subjects. A crossover
      design will be implemented for Group A subjects as follows: Group A subjects will be
      randomized into two sequences, Sequence 1 and Sequence 2. In Sequence 1, subjects will
      receive treatment A in Period 1 and treatment B in Period 2. There will be washout period of
      at least 7 days between Period 1 and Period 2 in Sequence 1. Similarly in Sequence 2,
      subjects will receive treatment B in Period 1 and treatment A in Period 2. There will be a
      washout period of at least 7 days between Period 1 and Period 2 in Sequence 2 as well.
      Treatment A and treatment B are defined as follows: Treatment A: subjects will be dosed with
      an oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the
      next dialysis session; • Treatment B: subjects will be dosed with an oral 90 mg ticagrelor
      tablet just prior to dialysis session.(NB: Treatment B dosing should occur within 5 minutes
      of dialysis start). Group B subjects (healthy subjects) with normal renal function (CrCL of ≥
      90 mL/min) will receive just an oral 90 mg ticagrelor referred to as treatment H. All doses
      will be administered in an open-label design.
    

Intervention name(s): ticagrelor; ticagrelor; ticagrelor
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Group A is hemodialysis subjects. Crossover design will be implemented for Group A subjects. Group A will be randomized into 2 sequences, Sequence 1 and Sequence 2. In Sequence 1, subjects will receive treatment A in Period 1 and treatment B in Period 2. Washout period of at least 7 days between Period 1 and Period 2 in Sequence 1. Treatment A and Treatment B are defined as follows: Treatment A subjects will be dosed with oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session. Treatment B will be dosed with oral 90 mg ticagrelor tablet just prior to dialysis session.; Group A is hemodialysis subjects. Crossover design will be implemented for Group A subjects. Group A will be randomized into 2 sequences, Sequence 1 and Sequence 2. In Sequence 2, subjects will receive treatment B in Period 1 and treatment A in Period 2. Washout period of at least 7 days between Period 1 and Period 2 in Sequence 2. Treatment A and Treatment B are defined as follows: Treatment A subjects will be dosed with oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session. Treatment B will be dosed with oral 90 mg ticagrelor tablet just prior to dialysis session.; Group B is healthy subjects. Group B healthy subjects will receive oral 90 mg ticagrelor referred to as Treatment H.
Other intervention name(s): Brilinta; Brilinta; Brilinta
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment