Safety, tolerability and PK of CHF 5993 in HV

• Research type

  Research Study

• Full title

  A single-center, randomized, double-blind, single dose, 4-way cross-over, placebo-controlled ethnic sensitivity study to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of different dosages of CHF 5993 pressurized metered dose inhaler (pMDI) in Caucasian and Japanese healthy subjects

• IRAS ID

  257260

• Contact name

  Jorg Taubel

• Contact email

  j.taubel@richmondpharmacology.com

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2018-003310-40

• Clinicaltrials.gov Identifier

  NCT03859414

• Duration of Study in the UK

  0 years, 4 months, 13 days

• Research summary

  Chiesi has developed CHF5993; an inhaled drug combining glycopyrronium bromide (GB) with a high strength fixed combination of both beclomethasone dipropionate (BDP) and formeterol fumarate (FF) for use in asthmatic patients that would benefit from an inhaled Long acting Muscarinic antagonist (LAMA) combined with corticosteroid (ICS) /Long acting B2 agonists (LABA).

  These drugs are licensed both individually and in combination, are safe, and are well tolerated with wide clinical usage. This same combination but at a lower dose of 100/6/12.5 micrograms (metered dose) was authorised by the European commission in July 2017 under the tradename Trimbow for treatment of chronic obstructive pulmonary disease.
  
  This trial, involving 32 healthy volunteers with equal numbers of Japanese and Caucasians, will compare the pharmacokinetic and pharmacodynamic profiles as well as assessing the safety and tolerability of three different doses of CHF5993 (200/12/25 micrograms, 400/12/25 micrograms, and 800/48/100 micrograms).

  There are four treatment periods, each with a single dose administration that will be separated by at least 21 days. In three of these periods volunteers will receive single doses of CHF5993 and one will be placebo. The order of these periods will be randomised.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  19/SC/0037

• Date of REC Opinion

  11 Mar 2019

• REC opinion

  Further Information Favourable Opinion