A Phase 1, First-in-Human Study of an Oral Formulation of Z944

• Research type

  Research Study

• Full title

  A Phase 1, First-in-Human, Double-Blind, Placebo Controlled Study to Determine the Safety, Tolerability, and Pharmacokinetics of an Oral Formulation of Z944 in Healthy Male Subjects in the Fasted and Fed State. Part I: Safety, Tolerability, and Pharmacokinetics of Single, Ascending Doses of an Oral Formulation of Z944 in the Fasted and Fed State. Part II: Safety, Tolerability, and Pharmacokinetics of Two Ascending, Repeated Doses of an Oral Formulation of Z944 in the Fasted State.

• IRAS ID

  92811

• Contact name

  Stuart Mair

• Sponsor organisation

  Zalicus Pharmaceuticals Ltd

• Eudract number

  2011-004828-35

• Research summary

  The study drug Z944 is being developed by the sponsor, Zalicus Pharmaceuticals, Ltd., for the potential treatment of chronic pain. This will be the first time the study drug has been dosed to humans. The objective of the study is to look at the safety of Z944 (study drug), how the body tolerates the drug and how the drug is taken up by the body when administered at different doses, by analysing multiple blood samples at various times after dosing with the study drug. The study has been split into two parts. Part 1 will look at the safety of Z944, and will assess how the body tolerates a single administration of one dose of Z944. Part 1 will be carried out in up to 90 healthy male subjects. The results from Part 1 will determine the doses of study drug to be investigated in Part 2. Part 2 will look at multiple administrations of different doses of Z944 in up to 16 healthy male subjects.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0181

• Date of REC Opinion

  8 Dec 2011

• REC opinion

  Further Information Favourable Opinion