* A Mass Balance, PK, and Metabolite Profile study of [14C]INCB086550

• Research type

  Research Study

• Full title

  An Open-Label Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB086550

• IRAS ID

  292857

• Contact name

  Samuel Israel

• Contact email

  samuel.lsrael@labcorp.com

• Sponsor organisation

  Incyte Corporation

• Eudract number

  2020-005879-12

• Clinicaltrials.gov Identifier

  REC Reference, 21/FT/0140

• Duration of Study in the UK

  0 years, 2 months, 3 days

• Research summary

  Summary of Research
  INCB086550 inhibits PD-L1 (CD274). PD-1 (CD279) is a cell-surface receptor expressed on activated T cells, natural killer T cells, B cells (cell types of the immune system), and PD-1 functions as an intrinsic negative feedback system to prevent the activation of T cells, which in turn reduces autoimmunity and promotes self-tolerance. In addition, PD-1 is known to play a critical role in the suppression of antigen-specific T-cell response in diseases such as cancer and viral infection. PD-1 binds to PD-L1, which is highly upregulated on many types of tumor cells as well as immune cells; therefore, targeting PD-L1 is an approach for the treatment of some types of cancer.

  Oral anti–PD-L1 agents such as INCB086550 may have significant advantages over biologics administered by other routes. A series of in vitro studies demonstrated that INCB086550 binds to human PD-L1 and disrupts the PD-L1 - PD-1 interaction.

  This is a Phase 1, single-centre, open-label mass balance study of [14C]-INCB086550. Study treatment will consist of a single 400 mg oral dose of INCB086550 with 240 mL of water followed 10 minutes later by an oral dose of approximately 100 μCi (3.7 MBq) [14C] INCB086550 (approximately 3.47 mg). Healthy male participants will receive study treatment on Day 1 after an 8 hour overnight fast, with food intake allowed no sooner than 4 hours post-dose.
  
  Participants will enter the CRU on Day –1 and remain until approximately Day 5 to Day 11, based on satisfying both of the following discharge criteria:
  •A minimum of 90% of the administered radioactive dose is recovered.
  •< 1% of the administered radioactive dose is recovered in excreta (urine and faeces combined) in 2 consecutive 24-hour urine and fecal collection samples.

  If the discharge criteria are not met, then participants will be discharged no later than Day 11.

  Summary of Results
  Not currently available

• REC name

  London - Central Research Ethics Committee

• REC reference

  21/FT/0140

• Date of REC Opinion

  4 Nov 2021

• REC opinion

  Further Information Favourable Opinion