Pharmacokinetic Study of NPSP795 in Healthy Subjects (QBR116751)

• Research type

  Research Study

• Full title

  An open-label, 3-period, non-randomised study in healthy subjects designed to evaluate the pharmacokinetic profile of NPSP795 following oral administration

• IRAS ID

  158179

• Contact name

  Pui Man Leung

• Contact email

  pui.leung@quotientclinical.com

• Sponsor organisation

  NPS Pharmaceuticals, Inc.

• Eudract number

  2014-000403-27

• Research summary

  The Sponsor is developing the study drug, NPSP795, for the potential treatment of a rare hormone disorder called Autosomal Dominant Hypocalcaemia.

  The study will try to identify how the body processes the study drug, comparing an intravenous (into the vein) formulation with 2 formulations given orally.

  The study will consist of 3 study periods involving up to 12 healthy male and female subjects. Each subject will receive the following formulations (one per study period with a minimum washout period of 2 days between each administration of the study drug):
  • Regimen A: 5.0 mg NPSP795 HCl Injection (0.87 mg/mL) for Intravenous Administration (reference)
  • Regimen B: 200 mg NPSP795 HCl Solution for Oral Administration
  • Regimen C: 200 mg NPSP795 HCl Drug in Capsule

• REC name

  Wales REC 2

• REC reference

  14/WA/1063

• Date of REC Opinion

  5 Aug 2014

• REC opinion

  Further Information Favourable Opinion