* Optimization of oral formulations of BI 685509 (QSC204968)

• Research type

  Research Study

• Full title

  Formulation selection and subsequent optimization of oral formulations of BI 685509 in healthy male subjects (open-label, randomized, single-dose design study in up to three parts; trial part 1: five-period crossover; optional trial parts 2 & 3: four period crossover)

• IRAS ID

  296519

• Contact name

  Dr Andreas Hünnemeyer

• Contact email

  andreas.huennemeyer@boehringer-ingelheim.com

• Sponsor organisation

  Boehringer Ingelheim Pharma GmbH & Co. KG

• Eudract number

  2020-005550-18

• Clinicaltrials.gov Identifier

  NCT04926246

• Duration of Study in the UK

  0 years, 5 months, 9 days

• Research summary

  Summary of research
  The Sponsor is developing the test medicine, BI 685509, for the potential treatment of chronic kidney disease and clinically significant portal hypertension (abnormally high pressure in the vein running from the stomach to the liver). The study is designed to identify an optimal recipe of the tablet form of BI 685509.

  The study will consist of up to 3 parts, Part 1 and optional Parts 2 & 3 (all randomised), enrolling a total of 39 healthy male volunteers. In Part 1, 15 volunteers will participate in five treatment periods, during each period they will receive a single dose of 3 mg BI 685509. Administration will be in fasted conditions for four treatment periods, and fed in the remaining one. After Part 1, the trial may be stopped or continue to Part 2. In Part 2, 12 volunteers will participate in four treatment periods; in one they will receive a 3 mg dose of BI 685509 and in each of the others they will receive a dose between 2 and 20 mg of the test medicine. Administration will be in fasted conditions for three treatment periods, and fed in the remaining one. After Part 2, the trial may be stopped or continue to Part 3. Part 3 will follow the same study design as Part 2, in a different group of 12 volunteers. For all parts, after each dosing occasion, blood samples for pharmacokinetic analysis (what the test medicine does to the body) will be collected and safety monitoring will be conducted.

  For all study parts, volunteers will be admitted to the clinical unit before their first treatment period and will remain resident until they finish their last treatment period. Volunteers will be required to attend an end of study visit 1-7 days after their final dose for safety assessments.

  Summary of Results
  Given that this is a phase 1 trial, no lay summary of results has been provided for reasons of commercial confidentiality

• REC name

  London - Brent Research Ethics Committee

• REC reference

  21/FT/0060

• Date of REC Opinion

  27 May 2021

• REC opinion

  Further Information Favourable Opinion