Safety, Tolerability, PK and PD of INT-767 in Healthy Males (117073)

• Research type

  Research Study

• Full title

  A Two Part, Single and Multiple Ascending Dose, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INT-767 in Healthy Male Subjects.

• IRAS ID

  188989

• Contact name

  Tessa Beecher-Jones

• Sponsor organisation

  Intercept Pharmaceuticals, Inc

• Eudract number

  2015-003100-23

• Duration of Study in the UK

  0 years, 8 months, 5 days

• Research summary

  The Sponsor is developing the study drug, INT-767 capsule, for the potential treatment of Primary Biliary Cirrhosis (PBC). \n\nThe study will try to identify the safety, tolerability and pharmacokinetics (how the drug is taken up by the body) of single ascending doses and multiple ascending doses of the study drug.\n\nThe study will consist of 2 study parts involving up to 91 healthy male subjects. In part 1, it is planned that 8 sequential groups, comprising of 8 male subjects, will participate in the SAD phase of the study. The proposed doses range between 1mg and 100mg and will be provide in capsule form.\n\nIn part 2 it is planned that up to 3 sequential groups, comprising of 9 subjects, will receive multiple ascending doses of study drug or placebo. Subjects will receive the study drug or matching placebo once daily for up to 14 days. The dose level will be determined from emerging data from Part 1 of the study.\n

• REC name

  Wales REC 2

• REC reference

  15/WA/0295

• Date of REC Opinion

  7 Oct 2015

• REC opinion

  Further Information Favourable Opinion