Safety, Tolerability and PK of OMS182399 (QCL117765)

• Research type

  Research Study

• Full title

  A Phase 1 Study in Healthy Subjects and Cigarette Smokers to Assess OMS182399 Safety, Tolerability and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses, and the PK of Alternative Formulations

• IRAS ID

  245202

• Contact name

  Soyoung Han

• Contact email

  shan@omeros.com

• Sponsor organisation

  Omeros Corporation

• Eudract number

  2018-001338-16

• Duration of Study in the UK

  0 years, 9 months, 6 days

• Research summary

  The Sponsor is developing the test medicine, OMS182399, for the potential treatment of various types of addiction, including addiction to nicotine (found in tobacco, cigarettes, and cigars). \n\nThis is the first time OMS182399 will be dosed in humans.\n\nThis multi-part study will try to identify the safety, tolerability and pharmacokinetics (PK; how well OMS182399 is taken up by the body) of single and multiple doses of OMS182399 in healthy volunteers. The PK of OMS182399 in the fed state (given with food), with alcohol, and alternative tablet formulations (recipes) may be assessed in optional groups/parts. The effect of OMS182399 on cravings in regular smokers will also be investigated as an exploratory objective.\n\nIn Part 1, single increasing doses of OMS182399 or placebo (dummy medicine) will be given to healthy volunteers as a solution to drink in the fasted and fed (optional) state. Up to 8 groups of 8 volunteers will be dosed. Each volunteer will remain in the clinical unit until 48 hours after dosing.\n\nPart 3 may commence before, in parallel or after Part 2.\n\nIn Part 2, multiple increasing doses eg 2 doses a day of OMS182399 or placebo will be given for 14 consecutive days. Up to 5 groups of 12 healthy volunteers and 1 group of 12 healthy regular smokers will be dosed with either a solution or alternative tablet formulation (chosen from Part 3). Volunteers will remain in the clinical unit until 48 hours after final dosing (Day 16).\n\nIn optional Part 3, the safety, tolerability and PK of alternative tablet formulations of OMS182399 may be tested in healthy volunteers. These may be given in the fasted or fed state or in the presence of alcohol. One group of 12 healthy volunteers will receive 6 single doses, with each volunteer remaining in the clinical unit until 48 hours after each dose.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  18/LO/0968

• Date of REC Opinion

  21 Jun 2018

• REC opinion

  Further Information Favourable Opinion