Safety, tolerability and PK of NNC0113-0987 (QBR110395)

• Research type

  Research Study

• Full title

  Investigation on safety, tolerability, and pharmacokinetics of single doses of NNC0113-0987 in healthy male subjects

• IRAS ID

  110798

• Contact name

  Joanne Collier

• Sponsor organisation

  Novo Nordisk

• Eudract number

  2012-000047-27

• Clinicaltrials.gov Identifier

  NCT01690169

• Research summary

  The Sponsor is developing the study drug, NNC0113-0987, for the potential treatment of type 2 diabetes. The study will try to identify the safety, tolerability and pharmacokinetics (PK), meaning how well it is absorbed into the bloodstream, of the study drug. This study will dose a range of single oral doses of NNC0113-0987 to healthy male subjects. This will be dosed as a SNAC tablet formulation - SNAC (sodium N-[8-(2-hydroxybenzoyl)amino]caprylate) is an absorbtion enhancer. Subjects will be randomised to recieve either the IMP or matching placebo. A total of 7 cohorts are planned, with 7 dose levels being investigated.

• REC name

  HSC REC A

• REC reference

  12/NI/0110

• Date of REC Opinion

  7 Aug 2012

• REC opinion

  Favourable Opinion