Bioequivalence study for Lu AF35700 (Study Lu 17481A)

• Research type

  Research Study

• Full title

  Interventional, randomized, open-label, three-group, two-sequence crossover, single-dose, bioequivalence study of Lu AF35700 in healthy subjects comparing the 5, 10 and 20 mg commercial tablet (test) to the 5, 10 and 20 mg clinical tablet (reference)

• IRAS ID

  232532

• Contact name

  Firas Almazedi

• Contact email

  firas.almazedi@covance.com

• Sponsor organisation

  H. Lundbeck A/S (Lundbeck)

• Eudract number

  2017-001335-39

• Duration of Study in the UK

  0 years, 6 months, 11 days

• Research summary

  Lu AF35700 is a new medicine that is being developed as a potential antipsychotic therapy in patients with treatment-resistant schizophrenia (TRS). Schizophrenia is a condition characterised by disturbances in thinking, perception and emotion. Lu AF35700 acts on several receptors (proteins) in the body (known as serotonergic, dopaminergic and alpha-adrenergic receptors).
  The purpose of this study is to establish if the current clinical and new commercial formulations of Lu AF35700 work in the same way for three tablet strengths: 5, 10 and 20mg i.e. to see whether the clinical and commercial formulations are 'bioequivalent'. The study will determine whether the levels in the blood are the same (equivocal) with each formulation of the study drug and will be used to obtain safety and tolerability information on each formulation.
  The study is a randomized open-label, three group, two sequence crossover, single dose bioequivalence study in healthy subjects. There will be 3 groups of 30 subjects. Within each group, subjects will be randomised to one of two treatment sequences and receive a single dose of the commercial tablet formulation (test treatment [A]) and the clinical tablet formulation(reference treatment [B]) on day 1 of period 1 and 2.
  All Subjects will be confined to the clinic from day -1 (Baseline) until day 6 (120 hours post dose). Each of the dosing periods (1 and 2) will be separated by a washout period of 6 weeks.
  All subjects will be seen for a follow up visit on Day 29 of period 2. Total study duration from period 1 baseline to the end of follow-up will be 13 weeks

• REC name

  North East - York Research Ethics Committee

• REC reference

  17/NE/0261

• Date of REC Opinion

  30 Nov 2017

• REC opinion

  Further Information Favourable Opinion