Metabolites & pulmonary deposition of CS-8958 in male HVs (QBR110166)

• Research type

  Research Study

• Full title

  An Open Label, Single Dose, Study in Healthy Male Subjects Designed to Identify and Quantify Metabolites after Administration of CS-8958 and to Assess the Pulmonary Deposition of CS-8958 after Inhaled Delivery

• IRAS ID

  113322

• Contact name

  Sharan Sidhu

• Sponsor organisation

  Biota Scientific Management Pty Ltd.

• Eudract number

  2012-002904-42

• Research summary

  The Sponsor is developing the study drug, CS-8958, for the potential treatment of flunzaflu caused by virus types A and B. The study will try to identify the metabolites (breakdown products) after administration of the study drug, and to assess pulmonary deposition (drug deposited into the lungs) after inhaled delivery. This study will dose CS-8958 in two regimens to 6 healthy male subjects: Regimen A: 40mg CS-8985 administered via oral inhalation using the TwinCaps© Drug Powder Inhaler (DPI), as ?½2 x 10 mg CS-8958, followed by ?½2 x 10mg CS-8958 radiolabelled with not more than (NMT) 20MBq 99mTc Radiolabelled CS-8958 will only be included following successful completion of the radiolabelling validation programme. Regimen B: 100æg [14C]-CS-8958, containing NMT 10kBq (270nCi) 14C, administered as an IV infusion

• REC name

  Scotland A REC

• REC reference

  12/SS/0178

• Date of REC Opinion

  8 Nov 2012

• REC opinion

  Further Information Favourable Opinion